Technical information GPS Safety Summary Chlorhexidine digluconate This Product Safety Summary is intended to provide a general overview of the chemical substance in the context of ICCA Global Product Strategy. The information on the summary is basic information and is not intended to provide emergency response information, medical information or treatment information. Substance name Chlorhexidine digluconate CAS-No. 18472-51-0 General statement Chlorhexidine digluconate is a chemical antiseptic substance with a number of commercial and industrial uses. The environmental effects, ecotoxicology and toxicology information available for this chemical is provided based on studies and/or a reliable evaluation of its hazardous properties. See Health and Environmental Effects. This chemical should not enter surface water, groundwater water and soil. See Risk Management Recommendations. Chemical identity Chemical name (IUPAC) N,N''-bis(4-chlorophenyl)-3,12- diimino-2,4,11,13- tetraazatetradecanediamidine digluconate Brand name Chlorhexidine digluconate CAS number 18472-51-0 EC number 242-354-0 Synonyms 1,6-bis-(5-(p-chlorphenyl)- biguanidino)-hexan-digluconate; chlorohexidine gluconate Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 1/6
Uses and application Chlorhexidine digluconate solution is used as a topical antiseptic and disinfectant as well as a preservative. It is used in pharmaceutical, medicinal, biocidial and cosmetic products. Physical/chemical properties Chlorhexidine digluconate is a colorless to light yellow powder with no odor. It is manufactured solely as 20% w/v solution in water (clear liquid). Property Value (pure substance) Physical state solid Color white to yellowish Odor none Density 1.3778 g/cm 3 Melting / boiling point 53 C / 157 C Flammability Not flammable Explosive Properties No Vapor pressure 5.1 10-5 hpa Molecular weight 897.8 g/mol Water solubility >75% (w/w) Octanol-water partition -1.81 (20.7 C) coefficient Health effects Chlorhexidine digluconate has low toxicity if swallowed or in skin contact. There is no data available for inhalation exposure. Due to the chemical character of the substance eye and skin irritation / damage may occur after contact. It is not a skin sensitizer. Standard tests indicate Chlorhexidine digluconate is neither mutagenic nor genotoxic. Data shows no evidence that Chlorhexidine digluconate is a reproductive toxin. Data available show no evidence of carcinogenicity. Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 2/6
Effect Assessment Result Acute toxicity (oral, dermal and inhalation) Irritation / corrosion skin / eye / respiratory tract Sensitization Toxicity after repeated exposure dermal / inhalation Genotoxicity/mutagenicity Carcinogenicity Toxicity for reproduction Low toxicity if swallowed or in skin contact. No data available for inhalation exposure. Risk of serious eye damage. Slightly irritating to the skin. Not a sensitizer. Repeated exposure consistant with acute oral, dermal and inhalation toxicity Not mutagenic / genotoxic No evidence that the material is carcinogenic based on available data. No evidence that the material is a reproductive toxin based on available data. Environmental effects Ecotoxicological studies for the aquatic compartment were performed on sewage sludge, fish, daphnia and algae, as well as on benthic and terrestrial organisms. Chlorhexidine digluconate is very toxic to aquatic organisms. It is highly adsorptive to soil, sediment and sewage sludge but does not bioaccumulate in environmental organisms. Experimental data on biodegradability of Chlorhexidine digluconate are inconclusive, but do not generally exclude biodegradability. Effect Assessment Aquatic toxicity Result very toxic to aquatic organisms - may cause long-term adverse effects in the aquatic environment.. Fate and Behavior Biodegradation Bioaccumulation potential PBT / vpvb conclusion Result Inconclusive data No bioaccumulation expected Not considered to be either PBT or vpvb Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 3/6
Exposure Human health Personnel exposure to this chemical in the manufacturing facilities is low because the process, storage and handling operations are enclosed. Normal industrial practices assure limited workplace exposures. These practices include handling with good ventilation. When containers and tanks are cleaned, residues are captured and treated. All workers are trained in the properties and safe practices of using chemicals including using personal protective clothing. It is concluded that there is no risk for any of the exposures considered for Chlorhexidine digluconate containing products for professional users and consumers. Therefore, it can be used safely within its low concentrations in medicinal, biocidal or consumer products. Environment The manufacture is a closed and automated process and no exposure to the environment are intended during production. The environmental concentrations have been calculated for releases from production, formulation and all known uses. All identified uses (including production as well as formulation of Chlorhexidine digluconate) are assessed as safe for human health and the environment during the performed risk assessment. Risk management recommendations When using chemicals make sure that there is adequate ventilation. Always use appropriate chemical resistant gloves to protect your hands and skin and always wear eye protection such as chemical goggles. All releases that may include the substance must be directed to a wastewater treatment plant that removes the substance from the final releases to the receiving water. Releases to air are not expected and therefore no specific recommendations are required. Waste is disposed of according to local authority regulations. State agency review Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) EU-GHS Regulation (EC) No 1272/2008 ICCA Global Product Strategy initiative Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 4/6
Regulatory information/classification and labelling GHS-Labeling Statutory basis GHS as per Regulation (EC) No 1272/2008 Symbol(s) Signal word(s) Hazard statement(s) Danger H318 - Causes serious eye damage. H410 - Very toxic to aquatic life with long lasting effects Precautionary statement(s) P273 Avoid release to the environment. P280 Wear protective gloves. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes.remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER or doctor/physician. P391 - Collect spillage. Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 5/6
This GPS Safety Summary is based on Evonik s present knowledge and experience as of the date of issue. However, it implies no liability or other legal responsibility on the part of Evonik, including with regards to existing third party intellectual property rights, especially patent rights. In no event shall Evonik be responsible for damages of any nature whatsoever resulting from the use of or reliance upon the information herein or the chemical to which that information refers. In particular, no warranty, whether express or implied, or guarantee in the legal sense is intended or implied by Evonik. This GPS Safety Summary is only intended to provide general information about the chemical referred to herein but not any in-depth health and safety information. The information in this GPS Safety Summary is supplied on the condition that the persons receiving the same will make their own determination as to its suitability for their purposes prior to use. This GPS Safety Summary does not supersede or replace required regulatory and/or legal communication documents. Performance of the chemical described herein should be verified by testing which should be carried out only by qualified experts. Evonik reserves the right to make any changes to this GPS Safety Summary in accordance with technological progress or further developments. Reference to trade names used by other companies is neither a recommendation, nor does it imply, that similar products could not be used. November 2011 Glossary Acute toxicity Biodegradable Bioaccumulation Carcinogenicity Chronic toxicity GHS Mutagenicity PBT Reprotoxicity Sensitizing Teratogenic vpvb harmful effects after a single exposure breakdown of materials by a physiological environment accumulation of substances in the environment effects causing cancer harmful effects after repeated exposures Global Harmonized System on Classification and Labeling effects that change genes Persistent Bioaccumulative Toxic teratogenicity, embryotoxicity and harmful effects on fertility allergenic effects on foetal morphology very Persistent very Bioaccumulative Contact information within company Email address sds-info@evonik.com Emergency Telephone number +49 (0)2365 49-2232 (Fire Brigade, Infracor GmbH) Emergency Telefax number +49 (0)2365 49-4423