Decanoic acid Product-type 4 (Food and feed area disinfectants)

Transcription

1 Draft Competent Authority Report Work Programme for Review of Active Substances in Biocidal Products Pursuant to Council Directive 98/8/EC Inclusion of active substances in Annex I to Directive 98/8/EC Document I Decanoic acid Product-type 4 (Food and feed area disinfectants) Rapporteur Member State Austria

2 COTETS 1. STATEMET OF SUBJECT MATTER AD PURPOSE Purpose for which the competent authority report was prepared Active substance: ame and address of applicant and manifacturers: Applicant Manufacturer of the active substance Manufacturer of the biocidal product Acceptance of the dossier and evaluation work OVERALL SUMMAR AD COCLUSIOS Presentation of the Active Substance Identity, Physico-Chemical Properties & Methods of Analysis Intended Uses and Efficacy Classification and Labelling of the active substance Classification and Labelling of the biocidal product Summary of the Risk Assessment Risk arising from physico-chemical properties Human Health Risk Assessment Hazard identification Effects assessment Exposure assessment Risk characterisation Environmental Risk Assessment Fate and distribution in the environment Effects assessment PBT assessment Exposure assessment Risk characterisation List of endpoints DECISIO Background to the Decision Decision regarding Inclusion in Annex I Elements to be taken into account by Member States when authorising products Requirement for further information Updating this Assessment Report Appendix I: List of endpoints Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling Chapter 2: Methods of Analysis Chapter 3: Impact on Human Health Chapter 4: Fate and Behaviour in the Environment Chapter 5: Effects on on-target Species Chapter 6: Other End Points Appendix II: List of Intended Uses Appendix III: List of studies Appendix IV-1: Standard terms and abbreviations Appendix IV-2: Abbreviations of Organisation and Publications... 62

3 1. STATEMET OF SUBJECT MATTER AD PURPOSE 1.1. Purpose for which the competent authority report was prepared This competent authority (CA) report and supporting Documents II-A, II-A confidential, II-B, II-B confidential, II-C, III-A and III-B have been prepared for submission to the European Commission to enable a decision to be made on the inclusion of Decanoic acid, as producttype (PT) 4, in Annex I of Directive 98/8/EC as a part of the review programme referred to in Article 16(2) of the Directive Active substance: Common name: Decanoic acid CAS-o.: EIECS- o: Molecular formula: C 10 H 20 O 2 OH Structural formula: O Molecular weight: Minimum degree of purity: g/mol 98.5%w/w 1.3. ame and address of applicant and manifacturers: Applicant ame: FATT ACIDS Consortium, p.a..v. Address: Rue de Trazegnies 199 B-6180 Courcelles Belgium Phone: Fax: Designated as confidential by the applicant Designated as confidential by the applicant Designated as confidential by the applicant 3

4 Manufacturer of the active substance ame: Cognis GmbH Address: Henkelstrasse 67 D Düsseldorf Germany Phone: Fax: Designated as confidential by the applicant Designated as confidential by the applicant Designated as confidential by the applicant Manufacturer of the biocidal product ame:.v. Address: Rue de Trazegnies 199 B-6180 Courcelles Belgium Phone: Fax: Designated as confidential by the applicant Designated as confidential by the applicant Designated as confidential by the applicant 1.4. Acceptance of the dossier and evaluation work This Evaluation Report was prepared by the Austrian Competent Authority. The dossier, including study reports and summaries, was accepted as if it was complete for evaluation on 14 August

5 2. OVERALL SUMMAR AD COCLUSIOS 2.1. Presentation of the Active Substance Identity, Physico-Chemical Properties & Methods of Analysis The active substance Decanoic acid is attributed the CAS-o and the EC-o The molecular formula is C 10 H 20 O 2, and the molecular weight is g/mol. The minimum degree of purity is 98.5%w/w. Structural formula: OH O The structure of Decanoic acid is confirmed by all spectra (IR, MR, UV/VIS and MS). The physico chemical properties are studied for the purified active substance of stated specification (min. 99%w/w Decanoic acid) according to the demands of the data requirements. Decanoic acid is a white crystal solid and has a rancid smell. Its melting point is in a range of C, and the boiling point range is C (10 mm Hg). The relative density is ρ = at 20 C. The vapour pressure of the active substance is 2.17 x 10-4 Pa at 25 C and x 10-4 Pa at 20 C. The calculated Henry s law constant is Pa x m 3 x mol -1 at 25 C. The water solubility of the water test item is 43 mg/l (20 C, unpuffered), 31 mg/l (20 C, ph 4), and 1843 mg/l (20 C, ph 7) and 2882 mg/l (20 C, ph 9). The water solubility at 35 C and at 50 C is not measurable. The dissociation constant of Decanoic acid in water is extrapolated to be in the range from 4.89 to 5.03.The solubility of Decanoic acid is >1kg/L Hexane at 22 C in g/l at > 1kg/L Ethanol 22 C. The active substance as manufactured does not include any organic solvent. The calculated partition coefficient octanol-water is 4.02 for the undissociated acid. Due to the similar molecular structure to Octanoic acid which is surface active, it is expected that Decanoic acid may also be surface active. The viscosity is 6.5 mpa s at 45 C. The active substance does not contain structural elements such as peroxide, nitro-group known to cause explosions. It is unlikely that Decanoic acid shows oxidizing properties under the condition of the test as described in the EU method A.14. Its flash point is 178 C. The heat of combustion is kj/mol, therefore auto flammability is not expected. The substance is stable up to the boiling point (146.8 C). Decanoic acid starts to decompose at C. Uncoated metal containers should be avoided. Plastic containers made of polyethylene or polypropylene and certified for use with acid are recommended The identification and quantification of Decanoic acid in the active substance as well as in the biocidal products SEPTACID B and SEPTACID B-PS is performed by using a GC system with FID detection. The method has been validated and shown to be sufficiently specific, accurate and sensitive. Due to the natural occurrence of Decanoic acid in the environment and its rapid metabolism and degradation in soil an analytical method for the determination of residues of Decanoic 5

6 acid in soil is not required according to the TsG on Data Requirements, Addendum to Chapter 2, Point 4 Analytical Methods for Detection and Identification. Due to the low vapour pressure of Decanoic acid no significant concentrations of Decanoic acid in air will occur. In accordance with the provisions given in the TsG on Data requirements no analytical method for Decanoic acid in air has been submitted. Deacnoic acid has been found to occur naturally in low concentrations in water. Although the degradation of Decanoic acid applied to water happens rapidly a GC/MS method has been developed to analyse residues in water with a limit of quantification of 0.1 µg/l. As Decanoic acid is not classified as toxic or very toxic, analytical methods for detection and identification of residues in animal and human body fluids and tissues were not assessed. An analytical method for the determination of residues of Decanoic acid in/on food or feedstuffs is not required because the active substance is not used in a manner that may cause contact with food or feedstuffs Intended Uses and Efficacy The assessment of the biocidal activity of the active substance demonstrates that it has a certain level of efficacy against the target organism(s). However, concerning efficacy of the representative biocidal product containing the active substance there were some experimental shortcomings which shall be amended at product authorisation stage. (See chapter 3.3 of this document). In addition, in order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the intended uses of the substance, as identified during the evaluation process, are listed in Appendix II of this document. 6

7 Classification and Labelling of the active substance Current classification according to Directive 67/548/EEC This substance is not classified in the Annex I of Directive 67/548/EEC. Proposed classification and labelling Table : Proposed classification and labelling according to Directive 67/548/EEC Hazard symbol Indication of danger Xi Irritating Dangerous for the environment R phrases S phrases Classification Labelling R38 R41 Irritating to skin Risk of severe damage to eyes R51/53 Toxic to aquatic organisms, may cause long-term adverse S26 effects in the aquatic environment. In case of contact with eyes rinse immediately with plenty of water and seek medical advice S36/37/39 Wear suitable protective clothing, gloves and eye/face protection S61 Avoid release to the environment. Refer to special instructions/safety data sheets. Xi; R38-R41 ; R51/53 Xi; ; R: /53 S: 26-36/37/

8 Table : Proposed classification and labelling according to Reg. 1272/2008/EC Classification and Labelling Justification GHS Pictograms Signal words Classification Hazard statements Danger Serious eye damage Hazard Category 1 Skin irritation Hazard Category 2 Aquatic Chronic Hazard Category 2 H318: Causes serious eye damage H315: Causes skin irritation H411: Toxic to aquatic life with long lasting effects Weight of evidence evaluation supporting skin irritation and risk for serious eye damage. Specification of Prevention Phrases according to Regulation (EC) o 1272/2008 General - Prevention P264 Wash thoroughly after handling P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection. Precautionary Statements Response P305 + P351 + P338: IF I EES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISO CETER or doctor/physician P302 + P352: IF O SKI: Wash with plenty of soap and water. P332 + P313: If skin irritation occurs, get medical advice/attention P362 Take off contaminated clothing and wash before reuse. P391 Collect spillage Storage - Disposal P501 Dispose of contents/container to 8

9 Classification and Labelling of the biocidal product Proposed classification and labelling Table : Proposed classification and labelling of the PT 4 biocidal product by RMS according to Directive 1999/45/EC Hazard symbol Indication of danger C corrosive R phrases S phrases Classification Labelling R34 Causes burns (calculation method and ph < 1) R52/53: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. S20/21 When using do not eat, drink or smoke S26 S36/37/39 S2 S61 C; R34 R52/53 C R: 34-52/53 S: /37/39-61 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing, gloves and eye/face protection Keep out of the reach of children Avoid release to the environment. Refer to special instructions/safety data sheets. 9

10 Table : Proposed classification and labelling of the PT 4 biocidal product by RMS according to Reg. 1272/2008/EC GHS Pictograms GHS05 Signal words Danger Classification Serious eye damage - Hazard Category 1 Hazard statements Prevention H314 Causes severe skin burns and eye damage (calculation m. and ph < 1) P260 - Do not breathe dust/fume/gas/mist/vapours/spray. P264 - Wash thoroughly after handling. P280 - Wear protective gloves/protective clothing/eye protection/face protection. Precautionary statement Response P301 + P330 + P331: IF SWALLOWED rinse mouth, do OT induce vomiting. P303 + P361 + P353: IF O SKI (or hair) remove/take off immediately all contaminated clothing, rinse skin with water/shower. P304 + P340: IF IHALED remove victim to fresh air and keep at rest in a position comfortable for breathing. P310: Immediately call a POISO CETER or doctor/physician. P305 + P351 + P338: IF I EES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Storage Disposal P405: Store locked up. P501: Dispose of contents/container in accordance with local/regional/ national/international regulation (to be specified). 10

11 2.2. Summary of the Risk Assessment Risk arising from physico-chemical properties In conclusion, no physico-chemical hazards could be identified for the active substance. Hence no classification is required on the base of physico-chemical properties (see also chapter of this document) Human Health Risk Assessment Hazard identification The only toxicological concern evident is the severely irritating property of the medium chain fatty acids. The overall evidence in literature, including a negative in vitro TER test with human skin (for skin corrosion) and positive human patch tests (for skin irritation), support the classification for skin irritation. According to OECD guideline 405 the severe skin irritation excludes further eye irritation testing with animals and should result in classification as severely eye damaging. Furthermore two publications were identified (Smyth et al. 1962, Briggs et al 1976) attributing score 9 from 10 for corneal necrosis or indicating corneal opacity and no reversibility up to 72 hours for Decanoic acid as well as Octanoic acid Effects assessment Decanoic acid and Octanoic acid are linear saturated fatty acids and they are ubiquitous in nature. The metabolic pathways are well established, they are similar for all fatty acids: complete catabolism for energy supply or conversion to fat suitable for storage. Due to this knowledge the evaluation was largely based on literature data and the toxicological hazard assessment for Decanoic acid and Octanoic acid is presented in a common chapter. either the available data for Decanoic acid and Octanoic acid on acute oral, dermal and inhalation toxicity, nor the publications with Medium Chain triglycerides and free fatty acids on subchronic rat dietary exposure or on developmental and reproductive toxicity give rise to concern for systemic toxicity, in spite of the high dose levels tested (all 1000 mg/kg bw day). These findings are in line with the acute, subacute and developmental toxicity data evaluated for onanoic acid in the context of the BPD 98/8/EC Annex I inclusion, which are owned by the respective applicant W.eudorff GmbH KG (see respective CAR). The Local Lymph ode Assay (LLA) with Decanoic acid is borderline positive, but the weight of evidence evaluation for skin-sensitisation resulted negative with regard to Decanoic and Octanoic acid. The absence of genotoxicity is supported by the evaluation of bacterial mutation tests, in vitro chromosomal aberration tests with the CHO cell line and in vitro gene mutation tests with mouse lymphoma cells, each of the three assays are available for Decanoic acid as well as Octanoic acid. Clearly long term irritation is stimulating cell replication and can present as such a promoting effect that is increasing cancer risk. But such tumour promoting effects without tumour 11

12 inducing (genotoxic) effects are not triggering classification. The conduct of a carcinogenicity study was considered not to be necessary; no new toxicological information is expected. The available publications with regard to reproductive toxicity do not indicate any toxicologically relevant maternal or foetal effects. A systemic short, medium and long term AEL of > 10 mg/kg bw/day is estimated based on no toxicological effects relevant for humans at 1000 mg/kg bw/day in an oral, 28 day rat study with the structurally related onanoic acid and consideration of daily uptake and metabolism of fatty acids as natural food content. However given the innocent character of linear saturated medium chain fatty acids with regard to systemic toxicity this AEL shall be considered as reference for a qualitative risk assessment, rather than a strict cut off value for un/acceptability of exposure estimates. The only toxicological concern evident is the severely irritating property of the medium chain fatty acids. The overall evidence in literature, including a negative in vitro TER test with human skin (for skin corrosion) and positive human patch tests (for skin irritation), support the classification for skin irritation. According to OECD guideline 405 the severe skin irritation excludes further eye irritation testing with animals and should result in classification as severely eye damaging. Furthermore two publications were identified (Smyth et al. 1962, Briggs et al 1976) attributing score 9 from 10 for corneal necrosis or indicating corneal opacity and no reversibility up to 72 hours for Decanoic acid as well as Octanoic acid. These irritant properties of Decanoic acid and Octanoic acid require also consideration of acceptable exposure concentrations (AECs) for local effects at the port of entry. A local oral medium and long term AEC of 1% is derived from the local forestomach OAEC of a 28 day rat study. The available data are insufficient for the derivation of local dermal and local inhalation medium or long term AECs. Therefore a qualitative risk assessment for local effects of the product was preferred 12

13 Exposure assessment Human exposure towards the active substance from its use in the biocidal product can take place via different routes of exposure, i.e. via inhalation, dermal contact and/or ingestion (see table ). Table : Main paths of human exposure to Decanoic acid as SEPTACID B (PS) Exposure path Primary (direct) exposure, during use of b.p. Professional use Secondary (indirect) exposure Incidental contact after application General public General Public Via the environment General Public Inhalation o 1 ot relevant ot relevant ot relevant 2 Dermal o 1 ot relevant ot relevant ot relevant 2 Oral o 1 ot relevant ot relevant ot relevant 2 1 As realistic worst case, dermal and inhalative exposure were assessed. 2 From TsG on Human Exposure, 2007: Exposure via the environment is an element of secondary exposure. It includes bystanders and consumers, including children, who are inadvertently exposed to biocides by inhalation of plumes drifting off-site and ingesting contaminated food. Those scenarios are not considered relevant in this case. The assessment of human exposure to the active substance Decanoic acid follows the recommendations of TsG on Human Exposure, The biocidal product is intended to be applied by professional workers for the cleaning of process installations by CIP (cleaning in place) in breweries. The whole cleaning processes are expected to be performed in closed apparatuses preventing any contact of the operators with the biocidal product. o primary exposure is expected during the application. Direct contact with the biocidal product was assessed as realistic worst case scenario, resulting in dermal and inhalation exposure. Subsequent to the use of the biocidal product, exposure for a consumer drinking beer which was processed in a brewery where the processing installations were disinfected with SEPTACID B (PS) may occur. (Secondary exposure; dietary exposure). Exposure calculations show that this scenario can be considered as not relevant. Also combined exposure (i.e. total exposure via all exposure routes arising from individual tasks through different phases of use), as well as aggregate exposure (i.e. exposure to a single chemical from multiple sources i.e. through primary exposure and secondary exposure) are assessed. Cumulative exposure which covers concurrent exposure to the same active substance from different biocidal products was not evaluated at present for Decanoic acid. Exposure of pets is considered to be not relevant. The exposure values relevant for risk characterisation are presented in chapter of this document. 13

14 Risk characterisation The representative products SEPTACID B and SEPTACID B-PS containing Decanoic and Octanoic acid with 1.5% each are corrosive due to the low ph of about 1 which is achieved with addition of co-formulants. Consequently the risk for local effects is clearly the major concern and the risk for systemic effects of the active substances from biocidal product exposure is comparably negligible. For application the corrosive products are diluted via pipe installations to concentrations of to 0.03%w/w a.s. each. The disinfectant solutions are finally applied as CIP (cleaning in place) in closed systems for processing installations in breweries. In exceptional situations where direct contact is not fully excluded, e.g. in case of exceptional maintenance work, application of protective gloves/ clothing and eye/face protection is necessary. The product is not marketed for general public. Within professional workplace environments including the proper application of the precautionary (GHS/CLP P-) phrases the risk for local effects is considered as acceptable. The diluted application solution is not corrosive but just skin and eye irritant. Anyway this solution is still used within closed systems. Only exceptional maintenance work may lead to exposure and this case appropriate personal protective equipment has to be used. Exposure to the irritant application solution could theoretically also lead to systemic effects. Therefore a risk estimate for systemic effects from SEPTACID B exposure is provided covering risk from exposure to the application solution. The respective exposure/ael ratio is clearly below 0.1. Thus the risk for local and systemic effects is considered acceptable with the intended use in professional workplace environments also for the diluted application solution. Table : Risk for systemic effects of the substance from application of the product Exposure Scenarios: Combined Scenarios for primary exposure during application Exposure to Decanoic acid via SEPTACID B Estimated Internal Exposure [mg/kg bw/day] Estim. oral uptake Estim. inhal. uptake Estim. dermal uptake Estim. total uptake (combined exposure) Relevant OAEL/ LOAEL [mg/kg b.w/day] & Reference Value AF MOEref MOE Exposur e / AEL Adult, tier 2 Dermal Exposure, Tier 2: Adult Contamination of both hands with SEPTACID B- Use of gloves OAEL: 1000 AEL system.: > > 3740 < Inhalation, Tier 1: Adult: Inhalation of air saturated with a.s.- 8 hours According to the estimates provided in Doc. II-B 4.4 the cleaning in place (CIP)-process contributes to 0.40 µg Decanoic acid per liter beer to the natural amount of Decanoic acid present in beer. Taking into consideration the toxicological reference value of 10 mg/kg bw day or 60 mg/person day the additional amounts present in beer as a consequence of the CIP process are clearly below any toxicological significance. 14

15 Environmental Risk Assessment Fate and distribution in the environment Decanoic acid is readily biodegradable (92% at day 28; pass level reached at day 5). The principal way of degradation of fatty acids under aerobic conditions is the microbial shortening by C2 pieces (β-oxidation of fatty acids). In addition the DT 50 soil from onanoic acid of 2.1 days at 12 C (Draft Competent Authority Report, Document I, onanoic acid, Product Type 19, 2008) was used for read across in order to refine the risk characterisation for the soil compartment of PT 4. Hydrolysis can be excluded by its structure, since Decanoic acid does not contain any functional group or reactive centre, which can be hydrolysed by nucleophilic OH - ions (at high ph values) or by electrophilic H 2 O + ions (at low ph values). Photolytic degradation in water is excluded for Decanoic acid, as it does not contain any functional group or reactive centre which displays chromophore properties at wavelengths above 290 nm. An estimation of photochemical degradation of Decanoic acid in air according to TGD resulted in a half-life of 34.5h (k deg, air = d -1 ; c(oh) air = 5x10 5 molecules/cm 3 ). Based on this result an accumulation of Decanoic acid in air is not expected. o adsorption equilibrium could be reached since Decanoic acid rapidly degraded in the test soils despite of soil sterilisation. Therefore K oc values could not be calculated. There is negligible likelihood for leakage of Decanoic acid to groundwater due to rapid degradation Effects assessment Aquatic compartment (fish, daphnids, algae, micro-organisms): The acute toxicity was investigated in zebra fish (Brachydanio Rerio) in a semi-static study for 96 hours conducted with Octanoic acid. The OEC was 22 mg/l (which corresponds to 26.3 mg/l Decanoic acid), the LC 0 46 (which corresponds to 55 mg/l Decanoic acid). The calculated LC 50 is 68 mg/l (corresponding to 81.2 mg/l Decanoic acid). Acute toxicity of Decanoic acid to daphnids (Daphnia magna) was investigated in a semistatic study. The highest tested nominal concentration causing no mortality after 48 hours was 10 mg/l. The EC 50 was 46 mg /L. A static study was conducted to estimate the the toxicity of Decanoic acid to the algae Scenedesmus subspicatus. The highest initial concentration tested at which the measured parameters do not show a significant inhibition of cell growth rate relative to control values is 0.57 mg/l (OE r C). The E r C 50 was 2 mg/l. As the test item decreases during the test period, the results are given in mean measured concentrations. o inhibitory effects against aquatic micro-organisms were found up to a nominal concentration of 1000 mg/l Decanoic acid. The respiration rates were enhanced up to the highest concentration. The OEC was determined with 1000 mg/l (nominal). 15

16 Air compartment: The half-life of Decanoic acid is estimated to be 34.5h. Based on this result an accumulation of Decanoic acid in air is not expected. On the basis of its physical and chemical properties, as e.g. absence of absorption bands in the so-called atmospheric window ( nm), short atmospheric lifetime and absence of Cl, F, or S substituents in the molecule, Decanoic acid is not expected to display adverse abiotic effects on the atmospheric environment. Therefore, no adverse biotic effects of Decanoic acid in atmosphere are expected. Terrestrial compartment: o initial terrestrial toxicity tests were submitted. According to the intended uses of the biocidal products only indirect exposure of the active substance to the terrestrial compartment is expected. Therefore, according to the TsG on data requirements no initial terrestrial toxicity tests are needed. However, a PEC for the terrestrial compartment was calculated according to the equilibrium partitioning method (TGD 2003) PBT assessment Persistence: Decanoic acid is readily biodegradable (91-92% mineralization after 28 days). At the end of the 10 days window at day 11 the mineralization rate was already 79-80%. The P-criterion is not met: ot P Bioaccumulation: BCF fish = 598 (calculated) The B-criterion is not met: ot B Toxicity: Chronic toxicity is available for algae only, the OEC is 0.57 mg/l. Endocrine disrupting effects and CMR effects: o specific test for potential endocrine disruption was carried out. From the available CMR studies and the repeated dose studies there is no evidence for endocrine disruption or for CMR effects (see Doc. II-A sections 3.5, 3.6, 3.7 and 3.8). The T-criterion is not met: ot T Conclusion: Decanoic acid does not meet the PBT criteria. 16

17 Exposure assessment The environmental exposure assessment has been performed in accordance with the Draft Emission Scenario Document for Product Type 4 (Disinfectants used in food and feed areas) 1 as well as the Technical Guidance Document (TGD II, European Commission 2003) 2 and the EUSES Background report (EC 2004) 3 and is based on information relating to the Intended Use. The environmental exposure assessment was conducted for the local scale only. In the ESD for PT 4 the environmental release pathway for substances used as disinfection in food, drink and milk industries (FDM) is described. According to the Intended Use the disinfection is performed by CIP (Cleaning in Place = disinfectant is added to the circulating water) treatment. It is assumed that the CIP treatment is only used once and then poured into the sewage. According to the ESD most of the disinfectant applied by CIP ends up in a sewage treatment plant. In the exposure scenario emission estimation is based on the annual tonnage of the active substance and the annual waste-water amount discharged by the plant. According to the ESD this is based on an industry survey, which showed that breweries have the lowest annual waste water release, thus representing a worst case with regard to the active substance concentration in the waste water. As recommended in the ESD two different default values for Temission (number of days for emission) were considered: 231 and 300 days. Predicted Environmental Concentrations (PECs) for the active substance for the relevant compartments are calculated for the influent (Clocal inf ) and effluent (Clocal eff = PEC STP ) of a sewage treatment plant and for the environmental compartments surface water (PEC sw ) and sediment (PEC sed ). In addition to that concentration in STP sludge (C sludge ) and the PECs for the active substance in soil after 30 and 180 days after sludge application (PEC soil ) and the porewater concentration (PEC gw ) are calculated. Subsequent to the use of the biocidal product secondary poisoning may occur. Therefore, the concentration of contaminated food (e.g. earthworms or fish) via ingestion by birds and/or mammals is calculated according to the TGD II (EC 2003). The exposure values relevant for risk characterization are presented in the following chapter. 1 Technical otes for Guidance: Supplement to the methodology for risk evaluation of biocides. Emission Scenario Document for Product Type 4: Disinfectants used in food and feed areas. 2 EC (2003)Technical Guidance Document in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) o 1488/94 on Risk Assessment for existing substances and Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Part II. 3 EC (2004) European Union System for the Evaluation of Substances 2.0 (EUSES 2.0). Prepared for the European Chemicals Bureau by the ational Institute of Public Health and the Environment (RIVM), Bilthoven, The etherlands (RIVM Report no ). Available via 17

18 Risk characterisation Air compartment: The PEC of Decanoic acid in air from its use may be considered negligible (see Doc. II-B, chapter 5.2.1). Moreover, Decanoic acid is not expected to have adverse biotic or abiotic effects on the atmosphere (see Doc. II-A, chapters and 4.2.2). Conclusion: Decanoic acid poses an acceptable risk for the air compartment. Aquatic compartment (including sediment): STP: Use of Decanoic acid as a disinfectant by CIP treatment will lead to emissions to sewage treatment plants, which are considered as the main receiving compartment. PECs were calculated for release of the waste water to an off-site STP (Scenario 2a) for 300 and 231 days of emission (see Doc. II-B, chapters 5.1 Fate and distribution in the environment and PEC in STP). The PEC for aquatic micro-organisms was determined with 100 mg/l (nominal) (see Doc. II-A, chapter Aquatic compartment). The PEC/PEC ratio for STP is calculated by dividing the PEC STP by the PEC aquatic microorganisms (see table ). Table : PEC/PEC ratios for STP Exposure scenario PEC STP (mg/l) PEC/PEC Sewage treatment plant (PEC aquatic micro-organisms 100 mg/l) Scenario 2a (231 days of emission) Scenario 2a (300 days of emission) x x10-3 Conclusion: Decanoic acid poses an acceptable risk to aquatic micro-organisms in sewage treatment plants. 18

19 Surface water incl. sediment: According to the Intended Use (Doc. II-B), no direct exposure to surface water, only indirect exposure via STP is possible assuming that the effluent of the sewage treatment plant is diluted into the surface water (see Doc. II-B, chapter 5.2.3). The concentrations in the solid phase of the sediment can be derived from the concentrations in surface water (see Doc. II-B, chapter 5.2.4). The PEC/PEC ratios for the aquatic ecosystem are derived by dividing the local PEC in surface water by the PEC for aquatic organisms. For the estimation of the PECs for aquatic and benthic organisms see Doc. II-A. Table : Local PEC/PEC ratios for aquatic compartment PEC in mg/l or mg/kg PEC/PEC Water/local (PEC water : mg/l) Scenario 2a (231 days of emission) Scenario 2a (300 days of emission) Scenario 2a (231/300 days of emission) annual average Sediment/local (PEC sediment : mg/l) Scenario 2a (231 days of emission) Scenario 2a (300 days of emission) The risk of Decanoic acid to sediment dwelling organisms is acceptable. A slight risk to aquatic organisms could be identified, since PEC/PEC ratios of 2.3 to 3.7 were calculated. However, based on the following reasons this calculated exceedance is acceptable. According to the worst case exposure scenario, the release of the disinfectant to waste water is by default 100%. A degradation during or after application (before release to the sewer system) is not considered, but expected because Decanoic acid is mixed with water and will therefore be degraded, since microorganisms use fatty acids for nutrition. o degradation in surface water was considered though Decanoic acid is ready biodegradable and degrades rapidly (DT 50 of 2.1 day at 12 C in soil, see Doc II-A, chapter ). A Further dilution in a river is also not considered. 19

20 Conclusion: Considering the arguments above, Decanoic acid poses an acceptable risk to aquatic organisms and the aquatic environment. Drinking water: If surface water is intended for the abstraction of drinking water during the emission period to an off-site STP, which is the relevant scenario, the local concentration calculated for Decanoic acid is above the parametric value of 0.1 µg/l according to Directive 98/83/EC (see table ). However, based on the reasons listed above (surface water concentrations) and mentioned below, this calculated exceedance of 21 µg/l or 13 µg/l (considering the annual average) is acceptable. Decanoic acid is a fatty acid. Fatty acids are important naturally occurring biological molecules, found in all living organisms. They may be regarded as having fundamental roles (i.e. they are the building blocks of structurally important molecules in cellular membranes and also serve as sources of energy for biological systems). According to the TDG II (EC 2003) the concentration in pore water of soil is taken as an indication for potential groundwater levels. The calculation of the predicted environmental concentration of Decanoic acid in groundwater after continuous sludge application over 10 years and taking into account degradation gives a value of 0.4 µg/l to 0.5 (see Doc. II-B, section 5.2.6). This slight above the parametric value of 0.1 µg/l according to Directive 98/83/EC. However, Decanoic acid has a low K oc (264 L/kg), which indicates that it will adsorb weakly onto soil. The calculation of the concentration according to formula 68 TGD neglects transformation and dilution in deeper soil layers. Thus this slight calculated exceedance is acceptable. Conclusion: Decanoic acid is not likely to have unacceptable effects on groundwater and the requirements of Directive 80/68/EC, 98/83/EC and 2006/118/EC are complied with. Terrestrial compartment: According to the intended use as a disinfectant applied by CIP in a closed system, direct emissions to the soil compartment are considered negligible. However indirect exposure of agricultural soils through fertilization with sludge from a STP is considered relevant. PECs were calculated for scenario 2a (off-site STP) for arable soil and grassland as the average concentrations over certain time-periods in agricultural soil fertilized with sludge from a STP. Additionally PECs were calculated for 300 and 231 days of emission to STP (see Doc. II-B, chapters 5.1 Fate and distribution in the environment and PEC in soil). The PEC for soil organisms with mg/kg wwt was calculated according to the equilibrium partitioning method on the basis of the PEC water (see Doc. II-A, chapter Terrestrial compartment). The PEC/PEC ratio for soil was calculated by dividing the PEC soil by the PEC soil (see table ). 20

21 Table : Local PEC/PEC ratios for the terrestrial compartment exposed via sewage sludge Exposure scenario PEC soil (mg/kgwwt) PEC/PEC PEC soil : mg/kg wwt Arable soil (averaged over 30 days) Scenario 2a (231 days of emission to STP) Scenario 2a (300 days of emission to STP) Arable soil (averaged over 180 days) Scenario 2a (231 days of emission to STP) 2.55x Scenario 2a (300 days of emission to STP) 1.96x Grassland (averaged over 180 days) Scenario 2a (231 days of emission to STP) 1.02x Scenario 2a (300 days of emission to STP) 7.84x Conclusion: Indirect exposure to Decanoic acid via sludge application poses an acceptable risk to soil organisms. 21

22 Secondary poisoning (on compartment specific effects relevant to the food chain): As the calculated octanol-water partition coefficient for Decanoic acid indicates a potential for bioaccumulation, a standard assessment for secondary poisoning was conducted. Risk for fish eating and worm eating predators o toxicity tests in birds were submitted for Decanoic acid. However, data of tests conducted with onanoic acid are available for read across. (Doc. I, chapter Effects assessment of the Draft-CAR onanoic acid, PT 19, 2008). For secondary poisoning, an initial standard assessment according to the TGD on risk assessment Part II (2003) was conducted. The risk to the fish- and worm eating predators is calculated in Table as the ratio between the concentration in their food (fish or earthworms) (see Doc. II-B, chapter 5.2.7) and the predicted no-effect concentration for long term oral intake (PEC oral chron ) (see Doc II-A, chapter 4.2.4). Table : PEC/PEC ratios for non compartment specific effects (secondary poisoning) Exposure scenario PEC PEC/PEC PEC oral chron a.s. mg/kg diet Aquatic food chain: 3.96 mg a.s./kg wet fish 12 Terrestrial food chain: Scenario 2a (231 days of emission) mg a.s./kg wet earthworm 0.11 Scenario 2a (300 days of emission) mg a.s./kg wet earthworm 0.08 The PEC/PEC ratio for secondary poisoning calculated for the terrestrial food chain indicates a low risk. The PEC/PEC ratio for secondary poisoning calculated for the aquatic food chain is above 1 indicating that a risk might be possible. Although the value is greater than 1, the risk can be seen as acceptable for the following reasons: The PEC oral chron is derived from studies where at the maximum test concentration no effects could be seen. The PEC oral chron is based on EC 50 values and not on OECs (but no mortalities or any other effects could be observed at the maximum test concentration). Decanoic acid is a fatty acid. Fatty acids are important naturally occurring biological molecules, found in all living organisms. They may be regarded as having fundamental roles (i.e. they are the building blocks of structurally important molecules in cellular membranes and also serve as sources of energy for biological systems). 22

23 Thus in predators no negative effects would be expected in concentrations higher than the concentrations tested and used for risk assessment accordingly. The PEC oral,predator is is based on the P ow only, not taking into account the metabolism of the substance and that Decanoic acid is readily degradable. Conclusion: Considering all the arguments above, the risk for fish eating and worm eating predators is considered to be acceptable. So the non compartment specific effects of secondary poisoning are low for the aquatic and terrestrial food chain List of endpoints In order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the most important endpoints, as identified during the evaluation process, are listed in Appendix I. 23

24 3. DECISIO 3.1. Background to the Decision On the basis of the proposed and supported uses and the evaluation conducted as summarised in this assessment report, it can be concluded that Decanoic acid fulfils under the conditions listed in chapter 2.2 the requirements laid down in Article 5 (1) (b), (c), and (d) of Directive 98/8/EC. Decanoic acid is proposed to be included in Annex I of the Directive Decision regarding Inclusion in Annex I The active substance Decanoic acid shall be included in Annex I to Directive 98/8/EC as an active substance for use in product-type 4 (food and feed area disinfectants), subject to the following specific provisions: Common name: IUPAC name: Decanoic acid (synonym: Capric acid). n-decanoic acid CAS-o.: EC- o: Minimum degree of purity: Product type: Specific provisions: 98.5%w/w 4 (food and feed area disinfectants) o special provisions are required Elements to be taken into account by Member States when authorising products 1) At product authorisation stage, a hazard and risk assessment for additional active substances and relevant components contained in the representative biocidal product should be performed. 2) Human exposure assessment: Rinsing efficiency of the post-rinse cycles is given by the applicant with 60% per cycle for small vessels and with 80% per cycle for big vessels without any justification for the provided numbers. The efficiency of the postrinse process should be substantiated by data at product authorisation stage as residues of active substance remaining on the walls of the vessels are transferred to the manufactured beer resulting in secondary exposure of consumers. 3) The evaluation has shown that the efficacy of Decanoic acid could not be fully demonstrated under the test conditions used. Therefore it is necessary that products based on Decanoic acid have to be tested at product authorisation stage to show a sufficient level of efficacy. 4) Information on suitable packaging material of the representative biocidal product should be submitted at product authorization stage. 24

25 3.4. Requirement for further information It is considered that the evaluation has shown that sufficient data have been provided to verify the outcome and conclusions, and permit the proposal for the inclusion of Decanoic acid in Annex I to Directive 98/8/EC Updating this Assessment Report This assessment report may need to be updated periodically in order to take account of scientific developments and results from the examination of any of the information referred to in Articles 7, 10.4 and 14 of Directive 98/8/EC. Such adaptations will be examined and finalised in connection with any amendment of the conditions for the inclusion of Decanoic acid in Annex I to the Directive. 25

26 APPEDIX I: LIST OF EDPOITS Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling Active substance Product-type PT 4 Decanoic acid Identity Chemical name (IUPAC) Chemical name (CA) n-decanoic acid Capric acid CAS o EC o Other substance o. Minimum purity of the active substance as manufactured (g/kg or g/l) Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg) n.a. 98.5%w/w Molecular formula C 10 H 20 O 2 There are no constituents in the substance which are classified as toxic, highly toxic or dangerous for the environment. Molecular mass Structural formula g/mol OH O Physical and chemical properties Melting point (state purity) Boiling point (state purity) Temperature of decomposition Appearance (state purity) Relative density (state purity) Surface tension Vapour pressure (in Pa, state temperature) C C ormal pressure Decanoic acid starts to decompose at C Solid; White crystal; Rancid density ρ= kg/l; Octanoic acid is surface active. Due to the similar molecular structure, it is expected that Decanoic acid may also be surface active x 10-4 Pa (25 C) x 10-4 Pa (20 C) Henry s law constant (Pa m 3 mol -1 ) Pa x m 3 x mol -1 (calculated) at 25 C Solubility in water (g/l or mg/l, state temperature) Water: 43 mg/l; ph 4: 31 mg/l; ph 7: 1843 mg/l; ph 9: 2882 mg/l. Solubility at 35 C and 50 C not measurable 26

27 Solubility in organic solvents (in g/l or mg/l, state temperature) Solubility in organic solvents of Decanoic acid is >1kg/L Hexane at 22 C and > 1kg/L Ethanol at 22 C Stability in organic solvents used in biocidal products including relevant breakdown products Expert Statement; ot relevant. The active substance as manufactured does not include any organic solvent Partition coefficient (log P OW ) (state temperature) Calculated with KOWWI: Log Kow = 4.02 Reference in the Program KOWWI: Log Kow = 4.09 for the undissociated acid Dissociation constant UV/VIS absorption (max.) (if absorption > 290 nm state ε at wavelength) Flammability The reported dissociation constant (pk. value at 25 C) of n-octanoic acid is 4.89 (Handbook of Chemistry and Physics, 79' edition , pp. 8-46/56). The dissociation constant (pk value at 25'C) of Decanoic acid in water is extrapolated from known pk values of other alkyl homologues and is expected to be in the range from 4.89 to The test substance shows an absorption maximum at nm and an minimum at nm in methanol, a maximum at nm and an minimum at nm In 1 HCl/methanol (90/10 v/v/) ad no absorption maximum or minimum in 1 aoh/methanol (10/90 v/v/) The heat of combustion is kj/mol (Kirk-Othmer Encyclopedia of Chemical Technology, 4th ed. Volumes 1: 1991), therefore auto flammability is not expected Explosive properties Decanoic Acid does not contain structural elements such as peroxide, nitro-group known to cause explosions. Classification and proposed labelling with regard to physical/chemical data with regard to toxicological data one Directive 67/548/EEC Xi; R38 - Irritating to skin, R4 - Risk of severe damage to eyes S26 In case of contact with eyes rinse immediately with plenty of water and seek medical advice S36/37/39 Wear suitable protective clothing, gloves and eye/face protection Reg. 1272/2008/EC Serious eye damage Hazard Category 1 Skin irritation- Hazard Category 2 H318: Causes serious eye damage H315: Causes skin irritation P264 Wash thoroughly after handling P280 Wear protective gloves/protective clothing/eye protection/face protection. P305 + P351 + P338: IF I EES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISO CETER or doctor/physician P302+P352: IF O SKI: Wash with plenty of soap and 27

28 with regard to fate and behaviour data ecotoxicological data and water. P332 + P313: If skin irritation occurs, get medical advice/attention P362 Take off contaminated clothing and wash before reuse. Classification: Directive 67/548/EEC ; R51/53 Toxic to aquatic organisms, may cause longterm adverse effects in the aquatic environment. S61 Avoid release to the environment. Refer to special instructions/safety data sheets. Reg. 1272/2008/EC Aquatic Chronic 2 H411: Toxic to aquatic life with long lasting effects P273 Avoid release to the environment. P391 Collect spillage P501 Dispose of contents/container to Chapter 2: Methods of Analysis Analytical methods for the active substance Technical active substance (principle of method) Impurities in technical active substance (principle of method) GC/FID method GC/FID method Analytical methods for residues Soil (principle of method and LOQ) Air (principle of method and LOQ) Water (principle of method and LOQ) Body fluids and tissues (principle of method and LOQ) Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) ot required according to the TsG on Data Requirements, Addendum, Part A, Chapter 2, Point 4 Analytical Methods for Detection and Identification ot required according to TGD on data requirements GC/MS method with a LOD of 0.1 µg/l for Decanoic acid ot required according to TGD on data requirements ot required according to TGD on data requirements ot required according to TGD on data requirements Chapter 3: Impact on Human Health Absorption, distribution, metabolism and excretion in mammals Rate and extent of oral absorption: Rate and extent of dermal absorption: Rate and extent of inhalative absorption: Fast and complete (no primary data, expected from textbook knowledge) Fast and complete (no primary data, expected from physchem and irritation) Fast and complete (no primary data, expected from 28