IMO EVALUATION OF NEW PRODUCTS. Fatty Acids, C12+ Submitted by the European Chemical Industry Council (CEFIC)

Transcription

1 ITERATIOAL MARITIME ORGAIZATIO E IMO BLG WORKIG GROUP O THE EVALUATIO OF SAFETY AD POLLUTIO HAZARDS OF CHEMICALS 12th session Agenda item 2 ESPH 12/2/14 19 July 2006 EGLISH OLY EVALUATIO OF EW PRODUCTS Fatty Acids, C12+ Submitted by the European Chemical Industry Council (CEFIC) Executive summary: Action to be taken: Paragraph 3.1 Related document: SUMMARY Fatty Acids, C12+ are proposed for inclusion in Chapter 17 of the IBC Code BLG.1/Circ.20 1 Background 1.1 Fatty Acids, C12+ are proposed for inclusion in Chapter 17 of the IBC Code. 1.2 At its forty-third session, the GESAMP/EHS Working Group on the Evaluation of the Hazards of Harmful Substances Carried by Ships considered the available data on the products Fatty Acids, C12+ provided by industry and the resultant hazard profile was shown in annex 4 of the document EHS 43/10, as attached to BLG.1/Circ The GESAMP Hazard Profile under the revised evaluation procedure is found hereunder: A1 A2 B1 B2 C1 C2 C3 D1 D2 D3 E1 E2 E3 Remarks 0 (R) 0 I (0) (0) (2) (1) (2) I I 2 2 Details of the proposal 2.1 Based on data provided by industry, it is proposed that Fatty Acids, C12+ be included in Chapter 17 of the revised IBC Code with the following carriage requirements: For reasons of economy, this document is printed in a limited number. Delegates are kindly asked to bring their copies to meetings and not to request additional copies.

2 - 2 - Column Entry a. Product name: Fatty Acids, C12+ c. Pollution category: Y d. Hazards: S/P e. Ship type: 2 f. Tank type: 2G g. Tank vents: Open h. Tank environmental control: o i. Electrical equipment: i Class; - i Group; - i Flash Point > 60 C Yes j. Gauging: O k. Vapour detection: o l. Fire protection: AB n. Emergency equipment: o o. Specific and operational requirements: , , In addition Chapter 19 of the IBC Code containing the Index of Products Carried in Bulk should be updated to include associated synonyms for these products. A separate proposal dealing with synonyms for a broad range of products has been submitted (ESPH 12/6/1). 2.3 The data related to this product are set out at annex to this document. 3 Action requested of the Working Group 3.1 The Working Group is invited to consider the data associated with these products and assign carriage requirements as indicated in 2.1 and 2.2 above. ***

3 BLG Product Data Reporting Form (Characteristics of Products proposed for Bulk Marine Transport) 1: Product Identity Product ame: Fatty Acids, C12+ (Dodecanoic Acid) The product name shall be used in the shipping document for any cargo offered for bulk shipments. Any additional name may be included in brackets after the product name 1.1: Other ames and Identification umbers Main Trade ame : Main Chemical ame : Chemical Formula : C 12 H 24 O 2 C.A.S umber : EHS umber : 2261 Structure CH 3 (CH 2 ) 10 CO 2 H BMR umber : RTECS umber : 1.2: Associated Synonyms Synonym ame Lauric Acid Laurostearic Duodecylic Acid 1- undecanecarboxylic acid Type trivial names 1.3: Composition Component ame % Type Single substance

4 Page 2 2: Physical Properties Property Units Qual Lower value Upper value Reference/ comments Molecular weight ºC (kg/m3) 869 Flash Point (cc) ( C) 160 Boiling Point ( C) 290 Melting Point/Pour Point ( C) 44 Water 20ºC (mg/l) 55 20ºC Vap. 20ºC (mpa.s) (Pa) AutoIgnitionTemp ( C) E Explosion Limits (% v/v) Carriage Temperature (ºC) E > 50 Unloading Temperature (ºC) E > 50 MESG (mm) 3: Relevant Chemical Properties Industry experience Water Reactivity (0-2) 0 0=o Reactivity 1=Reactive 2=Highly Details Does the product react with air to cause a potentially hazardous situation If so, provide details Reference

5 Page 3 Is an Inhibitor or Stabilizer needed to prevent a hazardous reaction? If so, provide details Reference Is refrigeration needed to prevent a hazardous reaction? If so, provide details Reference 4: Mammalian Toxicity 4.1 Acute Toxicity Qual Lower Val. Upper Val. Species Reference/ Comments Oral LD50 (mg/kg) > 10,000 Rat SDA report Dermal LD50 (mg/kg) E Rabbit R (See Other Tox Data) Inhalation LC50 (mg/l/4h) E Rat R (See Other Tox Data) 4.2 Corrosivity and Irritation Skin Corrosion time (hours) Resultant Species observation Reference/Comments Skin Irritation (4h exposure) ot Irritant Rabbit FADB Eye Irritation Irritant Rabbit FADB ot irritating, Slightly irritating, Mildly irritating, Moderately irritating, Severely irritating or Corrosive

6 Page Sensitization Respiratory Sensitizer (in humans) Skin Sensitization o known effects industry experience R o human sensitization reactions (See Other Tox Data) 4.4 Other Specific Long-Term Effects Carcinogen See Other Tox Data Mutagen S. typhimurium +/- activation (SDA) Toxic to Reproduction: Other Long term 4.5 Other Relevant Mammalian Toxicity Acute Mammalian Dermal Toxicity Data Taken Into Account Effect Qual Lower Val Upper Val Units Species Reference E> 6000 Rabbit Dodecandioc acid (SDA) Acute Mammalian Inhalation Toxicity Data Taken Into Account Effect Qual Lower Val Upper Val Units Species Reference LCO SVC Rat R onanoic acid (SDA) LCO SVC Rat R Decanoic acid (SDA) Additional otes on Mammalian Toxicity 1. Skin Sensitization R R o reactions in humans for C10 acid (1% in petrolatum) (FADB) o reactions in humans for C18 acid (7% in petrolatum) (FADB) 2. Carcinogenicity Swiss-Webster mice (F) were administered lauric acid in tricaprylin by sc injection 2/3 times per week for a total of 12mg or 125mg/animal. Observations were made twice per week for tumors for months no significant differences from control group were recorded. Lauric acid not considered to be a carcinogen (SDA).

7 Page 5 3. SDA Report Summary Points The following general points are noted in the SDA Report on Aliphatic Acids: Genetic toxicity in vitro; available data indicate that the chemicals in the category of aliphatic acids do not induce genetic toxicity under in-vitro conditions. Genetic toxicity in-vivo; based on structural properties, the lack of genotoxicity under in-vitro conditions and negative in-vivo results for the food oil castor oil, it is not expected that the chemicals in the category of aliphatic acids are genotoxic. Repeated dose toxicity; the category of aliphatic acids can be characterized as having a low order of repeated dose toxicity. Reproductive and Developmental toxicity; available data are consistent with the generally accepted low toxicity of these chemicals and the category can be characterized as possessing little potential for inducing reproductive or developmental toxicity.

8 Page 6 BLG Product Data Reporting Form (Characteristics of Products proposed for Bulk Marine Transport) 1: Product Identity Product ame: Fatty Acids, C12+ (Fatty Acids; linear C12+ saturated with C12+ unsaturated) The product name shall be used in the shipping document for any cargo offered for bulk shipments. Any additional name may be included in brackets after the product name 1.1: Other ames and Identification umbers Main Trade ame : Main Chemical ame : Chemical Formula : C.A.S umber : Various, e.g. Palm Oil FA , Veg. Oil FA EHS umber : 2261 BMR umber : RTECS umber : Structure Mixture of fatty acids (see composition) 1.2: Associated Synonyms Synonym ame Range of fatty acids/mixtures E.g. Palm Oil FA Veg; Oil FA Type trivial names 1.3: Composition Component ame % Type Various (see FADB)

9 Page 7 2: Physical Properties Property Units Qual Lower value Upper value Reference/ comments Molecular weight 20ºC Flash Point (cc) ( kg/m3) ( C) Boiling Point ( C) Melting Point/Pour Point ( C) Water 20ºC (mg/l) 70 20ºC (mpa.s) Vap. 20ºC (Pa) 7.2 E E-06 AutoIgnitionTemp Explosion Limits ( C) (% v/v) Carriage Temperature (ºC) E > 50 Unloading Temperature (ºC) E > 50 MESG (mm) # For additional information on component acids, see submissions for Fatty Acids; saturated, linear C12+ and Fatty Acids; unsaturated, linear C16+ 3: Relevant Chemical Properties Industry experience Water Reactivity (0-2) 0 0=o Reactivity 1=Reactive 2=Highly Details Does the product react with air to cause a potentially hazardous situation If so, provide details Reference

10 Page 8 Is an Inhibitor or Stabilizer needed to prevent a hazardous reaction? If so, provide details Reference Is refrigeration needed to prevent a hazardous reaction? If so, provide details Reference 4: Mammalian Toxicity Additional data for specific mixtures or veg. oil derived fatty acids are presented where available. For details of individual component acids see accompanying submissions for Fatty Acids; saturated, linear C12+ and Fatty Acids; unsaturated, linear C Acute Toxicity Qual Lower Val. Upper Val. Species Reference/ comments Oral LD50 (mg/kg) > 2000 Rat C14-18 and C16-18 unsat (SDA) Dermal LD50 Inhalation LC50 (mg/kg) (mg/l/4h) 4.2 Corrosivity and Irritation See component acids Skin Corrosion time (hours) Resultant observation Skin Irritation (4h exposure) ot irritant Species Reference/ comments R (from component acids) Eye Irritation ot irritant R (from component acids) ot irritating, Slightly irritating, Mildly irritating, Moderately irritating, Severely irritating or Corrosive

11 Page Sensitization See component acids Respiratory Sensitizer (in humans) Skin Sensitization 4.4 Other Specific Long-Term Effects Carcinogen See component acids Mutagen C14-18 and C16-18 unsat, S. typhimurium +/- activation (SDA) Toxic to Reproduction: See component acids Other Long term 4.5 Other Relevant Mammalian Toxicity Additional otes on Mammalian Toxicity 1. See comments for component acids. 2. SDA Report Summary Points. The following general points are noted in the SDA Report on Aliphatic Acids: Genetic toxicity in vitro; available data indicate that the chemicals in the category of aliphatic acids do not induce genetic toxicity under in-vitro conditions. Genetic toxicity in-vivo; based on structural properties, the lack of genotoxicity under in-vitro conditions and negative in-vivo results for the food oil castor oil, it is not expected that the chemicals in the category of aliphatic acids are genotoxic. Repeated dose toxicity; the category of aliphatic acids can be characterized as having a low order of repeated dose toxicity. Reproductive and Developmental toxicity; available data are consistent with the generally accepted low toxicity of these chemicals and the category can be characterized as possessing little potential for inducing reproductive or developmental toxicity.

12 Page 10 Fatty Acids, C12+ 5: GESAMP Hazard Profiles and Carriage Requirements 5.1: GESAMP Hazard Profiles Column Property Value A1 Bioaccumulation 0 A2 Biodegradation (R) B1 Acute Aquatic Toxicity 0 B2 Chronic Aquatic Toxicity I C1 Acute Oral Toxicity (0) C2 Acute Dermal Toxicity (0) C3 Acute Inhalation Toxicity (2) D1 Skin Irritation/Corrosivity (1) D2 Eye Irritation/Corrosivity (2) D3 Specific Health Concerns E1 Tainting and Odour I E2 Wildlife and Seabeds I E3 Beaches and Amenities 2 F Remarks

13 Page : Proposed Carriage Requirements Column in the IBC Code Property c Pollution Category Y d Safety/Pollution Properties S/P e Ship Type 2 f Tank Type 2G g Tank Vents Open h Tank Environmental Control o I Electrical Equipment - Class - I Electrical Equipment - Group - I Electrical Equipment Flashpoint > 60ºC Yes j Gauging O k Vapour Detection o l Fire Protection AB n Emergency Escape o Value o Special Requirements , ,