Technical information GPS Safety Summary Chlorhexidine base 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 Chlorohexidine base CAS-No 55-56-1 General statement Because Chlorohexidine base is used as an intermediate in the chemical industry under strictly controlled conditions, exposure is very limited. Consumer risk and exposure is very unlikely as Chlorohexidine base is manufactured and handled in industrial settings only. The environmental effects, ecotoxicology and toxicology information available for Chlorohexidine base is provided based on studies and/or a reliable evaluation of its hazardous properties. Chlorohexidine base should not enter surface water, groundwater water and soil. General and substance specific operational conditions and risk management measures are in place preventing exposure to workers and release to the environment. Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 1/7
Chemical identity Chemical name (IUPAC) 1,1'-Hexamethylenebis[5-(pchlorophenyl)biguanide] Brand name Chlorhexidine Base CAS number 55-56-1 EC number 200-238-7 Synonyms 2,4,11,13- Tetraazatetradecanediimidamide, N1,N14-bis(4-chlorophenyl)-3,12- diimino- Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 2/7
Uses and application Chlorhexidine base is used primarily as the starting material in the manufacture of other chemicals such as pharmaceuticals, antiseptic or biocides. Physical/chemical properties Chlorhexidine base is a white to yellow powder with no odor. Property Physical state Color Odor Density Melting / boiling point Explosive Properties Self-ignition temperature Molecular weight Water solubility Flash point Value solid white to yellow none 300-400 kg/m3 130 148 C / Not applicable If dust develops explosive dust/air mixtures may be formed. > 600 C 505.45 g/mol < 0.01 g/l Not applicable; solid Health effects Chlorhexidine base 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 base is neither mutagenic nor genotoxic. Data shows no evidence that Chlorhexidine base is a reproductive toxin. Data available show no evidence of carcinogenicity. Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 3/7
Effect Assessment Result Acute toxicity (oral, dermal and inhalation) Irritation / corrosion skin / eye 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. Chlorhexidine base is toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment. Chlorhexidine base is not readily biodegradable and no bioaccumulation is expected. Effect Assessment Aquatic toxicity Result Toxic to aquatic organisms. Fate and Behavior Biodegradation Bioaccumulation potential PBT / vpvb conclusion Result Not readily biodegradable. No bioaccumulation expected. Not considered to be either PBT or vpvb. Evonik Industries AG GPS Safety Summary November 2011 Version 1 page 4/7
Exposure Human health Chlorhexidine base is used as an intermediate in the chemical industry in closed systems under strictly controlled conditions. Worker exposure to this chemical in the manufacturing facilities is low because the process, storage and handling operations are enclosed. Specific operational conditions and risk management measures assure limited workplace exposures. These practices include handling with good ventilation. When containers and tanks are cleaned, residues are disposed of as hazardous waste. All workers are trained in the safety measures of handling the substance including using personal protective equipment. Consumers will not come in contact with Chlorhexidine base. Environment Chlorhexidine base is manufactured and used in the chemical industry in closed systems and therefore no release to the environment is expected. Direct use by consumers is not intended. Risk management recommendations Chlorhexidine base is transferred and handled in closed systems. Apparatus and pipelines are free from leaks. There is no ventilation to atmosphere. The emissions are minimized by appropriate technical measures. All personal protective measures (respiratory protection, hand protection, eye protection, skin and body protection) are strictly observed. All work is done by regularly trained personnel. The requirements for disposal are strictly monitored. 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 5/7
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) Precautionary statement(s) Danger H318 - Causes serious eye damage. H411 - Toxic to aquatic life with long lasting effects. P273 - Avoid release to the environment. P280 - Wear protective gloves/protective clothing/eye protection/face protection. 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 6/7
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