GHS Classification Result （Revision of the past classification result）

Chemical Name：Acetamide
CAS：60-35-5

Result：
ID: 21B3072
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 is an organic compound containing oxygen (but not fluorine or 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 LD50 values of 7000 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol. 5 (2006)) and 10300 mg/kg (IARC vol. 7 (1974)) for rats, the substance was classified into "Not classified".
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 - - - - In regard to the effect of the substance on human skin, these are reports that the substance is irritating to the skin and causes erythema and pain (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 5 (2006)) and relative lack of irritant effects on the skin and mucosa (HSDB (2002)). Based on these information, skin irritancy of the substance is considered to be mild and the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		In regard to the effect of this substance on human eyes, there are reports that the substance is irritating to the eyes and causes redness and pain (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 5 (2006)) and the substance is irritating to the eyes in short-term exposure (ICSC (1997)). Based on these reports, eye irritancy of the substance is considered to be mild and the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - In bone marrow micronucleus tests by oral administration to mice (in vivo somatic cell mutagenicity tests), one of three tests reported a "marginally positive" result (IARC 71 (1999)) and the other 2 tests (conducted with higher doses) reported negative results (IARC 71 (1999)). The substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there is a report of a negative reverse mutation test using Salmonella typhimurium (IARC 71 (1999)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the classification of "Group 2B" in IARC (IARC vol. 71 (1999)), the substance was classified into Category 2. As relevant information, the substance is classified into Category 2B in Japan Society For Occupational Health (JSOH) and as Category 3 in EU classification (Recommendations for allowable concentrations (2004), JETOC No. 188 (2004)). There are more than one report that an increase in the incidence of liver tumours was found in rats by oral (feeding) exposure (IARC vol. 71 (1999)). In a 1-year feeding test in mice, an increase in the incidence of malignant lymphomas was observed (IARC vol. 71 (1999)).
7 Reproductive toxicity Classification not possible - - - - In a rabbit oral test, a decrease in fetal viability was observed at dose levels of 1000 mg/kg/day and higher, and an increase in embryo resorptions was observed at a dose level of 3000 mg/kg/day (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 5 (2006)). However, since the same report was estimated to be negative in another document (Birth Defects (3rd, 2000)), classification was not possible.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Maximum tolerated doses after oral exposure are reported to be 7.5 and 8.0 g/kg in rats and mice, respectively (IARC vol. 7 (1974)). Significant toxic effects are considered to occur at levels higher than the maximum tolerated doses, which exceed the guidance value range for Category 2 (2000 mg/kg). The substance corresponds to "Not classified" with the oral route, however classification was not possible due to lack of data with other exposure routes.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - Classification not possible due to lack of data. In 35-week or 1-year feeding tests in rats, light microscopic findings (proliferation of smooth endoplasmic reticulum and abnormal nuclei in the liver) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 56 (2006)) and electron microscopic finding (fatty degeneration) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 56 (2006)) were observed. These findings were noted at 5% (approximately 2500 mg/kg/day) or 2.36% (approximately 1180 mg/kg/day) dose levels which exceed the guidance value range.
10 Aspiration hazard Classification not possible - - - - Classification was not possible due to lack of animal data or human case report.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Not classified - - - - Classified into Not classified from its 24h-EC50 >10 g/L for Crustacea (Daphnia magna) (AQUIRE, 2010).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility = 2250000 mg/L (PHYSPROP, Database, 2009).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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