GHS Classification Result

Chemical Name:triclosan; 2,4,4'-trichloro-2'-hydroxy-diphenyl-ether; 5-chloro-2-(2,4-dichlorophenoxy)phenol
CAS:3380-34-5

Result:
ID: 20A2228
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

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 solid 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 <= 140degC) substances are not available. (melting point: 54-57.3degC (Merck (14th, 2006)), melting point: 60-61degC (Ullmanns(E) (6th, 2003)), melting point: 54-57.3degC (Howard (1997)))
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 - - - - Organic compounds containing chlorine and oxygen (but not fluorine), which are chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
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 - - - - Its rat LD50 = 3700 mg/kg (RTECS (2003)) and its mouse LD50 = 4530 mg/kg (RTECS (2003)). Since the difference of these LD50 values between two animal species is small, the substance was categorized into "Not classified" in the JIS classification (Category 5 in the United Nations classification).
1 Acute toxicity (Dermal) Classification not possible - - - - Its LD50 value = 9300 mg/kg (RTECS (2003)), which indicates that the substance is to be classified into "Not classified". However, since this dataset is of List 3, the substance was classified into "Classification not possible" due to lack of data.
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 - - - - Since Draize tests concluded that the substance causes mild irritation in both rabbits and humans (RTECS (2003)), it was classified into "Not classified" (Category 3 in the United Nations classification).
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - There are no reports on animal tests; but as medical cases and epidemiological information, negative results were obtained in sensitization tests in humans who used soapy water containing the test substance (HSDB (2004)). On the other hand, in blind half-side usage tests, itching and erythema was induced, indicating that the test substance is a possible sensitizer (HSDB (2004)). In addition, positive results were obtained in patch tests in which the test substance was applied to patients with allergic contact dermatitis caused by the use of deodorant foot powder containing the test substance. Although the positive results indicate that the test substance is possibly a sensitizer, judgment between positive and negative reactions cannot be made. Thus, the substance was classified into "Classification not possible".
5 Germ cell mutagenicity Classification not possible - - - - In vivo data documented include a mouse spot test, which was conducted using a range of administration doses that is known to cause toxic effects. In this test, a significant increase in mutation of somatic cells in treated groups was not observed compared with control groups that were administered with methanol (HSDB (2004)). Since this test was conducted within a range of toxic exposure, the substance was classified into "Classification not possible" based only on this test.
6 Carcinogenicity Classification not possible - - - - There is a report that in 18-month dermal toxicity tests using mice, signs of carcinogenicity, pathological abnormality or abnormal tumorigenesis were not detected (HSDB (2004)). However, since no proper information other than this dataset is available, classification is not possible.
7 Reproductive toxicity Classification not possible - - - - In oral administration tests using female rats that were treated for 7 to 17 days during the gestational period, effects on embryos and mortality of fetuses were documented (RTECS (2008)), but detailed descriptions on observations of toxic effects are not available. Thus, classification is not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - There is a description that histopathological examinations were conducted in 4-week oral administration tests using rats (HSDB (2004)); however, detailed data are not provided. In subacute dermal toxicity tests using rats, it is documented that signs of systemic toxicity were not detected in observations of the substance's toxic effects (HSDB (2004)). Overall, classification is not possible based on this information only.
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 ...
Based on its 72-hour EC50 of 0.0034 mg/L for algae (Pseudokirchneriella subcapitata) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2001), the substance was classified into Category 1.
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 ...
Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (non-biodegradable, BOD degradability: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), the substance was classified into Category 1.


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)


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