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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	60-35-5
Chemical Name	Acetamide
Substance ID	25B0058
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2009 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
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 <= 140 deg C) 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 in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" based on reports on LD50 values for rats of 10,300 g/kg (IARC 7 (1974)) and 7,000 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is described in the Environmental Risk Assessment for Chemical Substances vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006) that as effects in humans, it irritates the skin and causes redness and pain in contact with the skin.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported in the Environmental Risk Assessment for Chemical Substances vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006) that as effects in humans, it irritates the eye and causes redness and pain in contact with the eye.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, it was marginally positive in one out of three micronucleus tests with mouse bone marrow cells, but negative results were obtained in the other two tests at higher doses, which were reported later (IARC 71 (1999)). As for in vitro, it was negative in a bacterial reverse mutation test (NTP DB (Access on September 2013), IARC 71 (1999)). Besides, there are no data in in-vitro chromosomal aberration tests.
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 based on Group 2B in IARC's classification (IARC (1999)), "Carc. Cat. 3; R40" in EU DSD classification, and "Carc. 2 H351" in EU CLPclassification.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a developmental toxicity test with rabbits in the oral route (gavage), a decreased survival rate and lower body weights of fetuses in the groups of 1,000 mg/kg/day or above and increased resorptions in the 3,000 mg/kg/day group were observed (Environmental Risk Assessment for Chemical Substances vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). As a result of investigating whether there was maternal toxicity in the test, slight toxicity (details unknown) at 1,000 mg/kg bw/day and reduced weight gain, respiratory distress, and restlessness at 3,000 mg/kg/day were found (Markle, J. and H. Zeller (1980)). It was classified in Category 2 because a decreased survival rate of fetuses was observed at the dose where effects were seen in maternal animals from the above.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is described that maximum tolerated doses by oral exposure for rats and mice were 7.5 g/kg and 8.0 g/kg, respectively (IARC 7 (1974)). Because the dose that causes toxicity effects was estimated to be at least equal to or higher than the maximum tolerated doses, it falls under "Not classified" in the oral route. However, because of no information on the other routes, it was classified as "Classification not possible."
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, effects on the liver were observed in diet administration tests in which rats were administered higher doses equivalent to "Not classified" for 35 weeks (5%: equivalent to 2,500 mg/kg/day), or one year (2.36%: equivalent to 1180 mg/kg/day) (Environmental Risk Assessment for Chemical Substances vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)).
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 24-hour EC50 > 10000 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 13300 mg/L for fish (Gambusia affinis) (both AQUIRE, 2013).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (water solubility = 2.25x 10^6 mg/L, Howard, 1997), and it was classified as "Not classified" in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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