GHS Classification Result

Chemical Name：Chlorhexidine
CAS：55-56-1

Result：
ID: 21A3619
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance contains chlorine which is chemically bonded only to carbon.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Based on a LD50 value of 5000 mg/kg bw for rats (HSDB (2004)), the substance was classified into "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - Based on a result of "not irritating" in a rabbit test (OECD TG404) (IUCLID (2000)), the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		Based on a report that all 3 rabbits showed corneal opacities (score: 2 or more), iritis (score: 1 or more) and chemosis (score: 2 or more) at 24-hour after application of 100 mg to the eyes, that the effects were not reversible until 48-hour after application, and the MMAS (correspond to AOI) was calculated to be 82.3 (ECETOC TR48 (1998)), the substance was classified into Category 1. As relevant information, there is a result of "highly irritating" in another rabbit test (OECD TG405) (IUCLID (2000)).
4 Respiratory sensitization Category 1 Danger H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled P304+P341: IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P285: In case of inadequate ventilation wear respiratory protection.
P501: Dispose of contents/container to ... 		There is a report that occupational asthma in two health care workers, as a result of exposure to this substance and alcohol aerosols (HSDB (2004)). The first case involved a 54-year-old nursing auxiliary who experienced frequent attacks of cough and wheezing within minutes after using an aerosol containing this substance, and in a challenge test with this substance, her forced expiratory volume in 1 second fell, accompanied by chest tightness and cough. The second case involved a 43-year-old midwife with a 6 month history of chest tightness after exposure to this substance and alcohol aerosol. A bronchial provocation test showed a fall in forced expiratory volume in 1 second. Neither woman had a history of asthma and no increased airways responsiveness to histamine was demonstrated in either case. The use of this product was stopped, and both nurses remain free of symptoms. It is concluded that the diagnosis of occupational asthma was confirmed (HSDB (2004)). Additionally, there are reports that following intermittent or repetitive use of chlorhexidine, asthma and anaphylactic shock occur as instant responses (FROCH, TEXTBOOK OF CONTACT DERMATITIS). The substance was classified into Category 1.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		Eczema patients were tested with chlorhexidine-gluconate and chlorhexidine-acetate by patch test and positive reactions were found in 52 (5.4%) of the 1063 subjects. Of these subjects, 29 patients were still found to have positive reactions in retest and a use test resulted in all of them developing dermatitis (HSDB (2004)). Additionally, there is a report that after intermittent or repetitive use of chlorhexidine, contact dermatitis, photosensitivity reaction and eczema can occur, and contact urticaria and anaphylactic shock may occur as instant responses (FROCH, TEXTBOOK OF CONTACT DERMATITIS). Additionally, there are reports of "shock symptoms" in information on adverse reaction and "hypersensitivity (such as skin rash)" in other adverse effects (JAPIC prescription drug database (access on Feb. 2010)). Based on these information, the substance was classified into Category 1.
5 Germ cell mutagenicity Classification not possible - - - - No data available.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Classification not possible due to lack of data. In a drug package insert for a topical disinfectant containing the substance, it was reported that direct application to the auditory nerve and central nerve may cause hearing impairment and neurological disorder. Additionally, application of chlorhexidine preparation to the mucous membrane of the vagina, urinary bladder and oral cavity can cause shock symptoms (initial symptoms: nausea, discomfort, cold sweat, dizziness, chest discomfort, dyspnea and flare) (e-Phama (access on Feb. 2010)). Anaphylactic shock can occur as instant responses (FROCH, TEXTBOOK OF CONTACT DERMATITIS). However, the effects on central nerve can be caused by unconventional exposure routes and the shock symptoms may not be acute effects.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - No data available.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 from its 96h-LC50 = 0.0013 mg/L for fish (Rainbow trout) (HSDB, 2004).
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (BIOWIN).


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information