NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	79-39-0
Chemical Name	Methacrylamide
Substance ID	m-nite-79-39-0_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It contains chemical groups (unsaturated bond) associated with self-reactive properties in the molecule. Since no test results are available, classification is not possible.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	Since it is reported that the substance is not pyrophoric [product zeigt keine selbstentzundung] (IUCLID (2000)), the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 degC) substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen which is chemically bonded only to carbon.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the seven LD50 values for rats of 1789 mg/kg, 1774 mg/kg (the above data from "Toxicity Testing Report of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)), 459 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) Vol. 7 (2009)), 1938 mg/kg, 1653 mg/kg, 1580 - 1950 mg/kg and 1750 mg/kg (the above data from SIDS (Access on Jul. 2010)), the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Insufficient data were available. The rat LDLo value of > 1600 mg/kg was reported (SIDS (Access on Jul. 2010)). Since this value did not provide the basis for classification, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Although it was reported that 8-hour exposure for rats at the saturated vapor pressure concentration caused no toxic effects (SIDS (Access on Jul. 2010)), the classification was not possible due to lack of data.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	There were two test data in conformity with OECD TG 404 and GLP. In the first test, slight erythema in all 3 rabbits was reported after patch removal, but symptoms were reversible after 24 hours. The primary irritation index score was 0.0 and resulted as "not irritating" (SIDS (Access on Jul. 2010)). In the second study, slight to well defined erythema was noted in all 3 rabbits after patch removal, and very slight edema was noted in 1 animal. These symptoms recovered within 7 days. The primary irritation index score was 1.11 and resulted as "slightly irritating" (SIDS (Access on Jul. 2010)). Based on the information, the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In the rabbit tests (OECD TG 405, GLP-compliant), instillation of 0.1g of test substance caused corneal opacity (Grade 1) in all 3 animals, iritis (Grade 1) in 1 animal, redness and chemosis of conjunctiva (Grade 2) in all 3 animals. Symptoms recovered in 7 days. The primary irritation index score was 3.38/13 and resulted as moderately irritating (SIDS (Access on Jul. 2010)). Based on the information, the substance was classified as Category 2B.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	There were two test data of sensitization using guinea pigs. One showed slightly sensitizing, and the other revealed not sensitizing reciprocally (SIDS (Access on Jul. 2010)). In the human case, two out of the 5 patients who contacted with 1% solution showed positive reaction. However, the authors described that these reactions were not distinguished between irritative and sensitizing reaction (SIDS (Access on Jul. 2010)). The substance was classified as "Classification not possible" because sufficient data is not available on skin sensitization.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The classification was concluded as "Not classified" based on negative results in the dominant lethal test in mice administered via drinking water (in vivo inheritable mutagenicity test in germ cells) with no early embryonic death and post-implantation death (SIDS (Access on Jul. 2010)). As relevant information, as for in vitro studies, negative results in the Ames test (OECD TG 471, GLP-compliant) and the chromosome aberration test using CHL/IU cells (OECD TG 473, GLP-compliant) ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the oral administration study using pregnant mice during the organogenetic period, increased postimplantation death was observed at doses at which decreased body weight gain was observed in maternal animals (SIDS (Access on Jul. 2010)). In the study using pregnant mice injected intraperitoneally on days 11 - 15 of gestation, increased resorption and abortions were observed at doses at which decreased body weight gain was observed in maternal animals (SIDS (Access on Jul. 2010)). Therefore, the substance was classified as Category 2. In the studies mentioned above, no treatment-related occurrence of morphological abnormalities was seen. In addition, in the one generation oral administration study of rats or two generation oral administration study of mice, no effects on sexual functions and fertility of parental animals were observed ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Jul. 2010), SIDS (Access on Jul. 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In the single dose oral toxicity study in rats, the effects observed in dose groups at 1512 mg/kg or more included the clinical signs such as staggering gait, tremors, salivation, sitting position, and histopathological alterations in surviving animals in both sexes as follows: degeneration or necrosis of neuronal cells in central nerves as well as degeneration of peripheral nerve fibers ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)). Thus, the classification was determined as Category 2 (nervous system). In addition, it was reported that sedation and piloerection at 1000 mg/kg or higher and signs such as ataxia, prone position or somnolence at 2000 mg/kg or higher were observed in another oral study in rats (SIDS (Access on Jul. 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system)	Warning	H373	P260 P314 P501	In the 28-day repeated oral dose study in rats, the animals exhibited neural signs at 300 mg/kg/day (converted dose level as that of 90-day study: 98.3 mg/kg/day), and showed histopathological findings containing degeneration of sciatic nerve fibers and axonal swelling in cerebellar peduncle. Neurotoxic effects were not reversible after 14-day recovery period ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)). Moreover, in the 12-month study by drinking water in rats or mice, reduction in the rotarod performance in both species at 800 ppm (19.5 mg/kg/day) or higher, peripheral neuropathy in rats at 1200 ppm (31.6 mg/kg/day) or higher and in mice at 800 ppm (120 mg/kg/day) or higher, paralysis of hind limbs in rats at 1200 ppm (31.6 mg/kg/day) and in mice at 400 ppm (49.6 mg/kg/day) or higher were observed, respectively. Histopathological examinations revealed shrinkage and loss of myelinated fibers of the sciatic nerve at 800 ppm (19.5 - 120 mg/kg/day) or higher in both species (SIDS (Access on Jul. 2010)). As stated above, neurotoxicity was demonstrated in multiple studies at the doses equivalent to Category 2 within the range of the guidance values. Thus, the substance was classified as Category 2 (nervous system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	Classified as "Not classified" from its 96h-LC50 > 100 mg/L for fish (Oryzias latipes), 48h-EC50 > 1000 mg/L for crustacea (Daphnia magna) and 72h-EC50 > 1000 mg/L for algae (Selenastrum capricornutum) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1999).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since it is not non-water soluble (water solubility = 213 g/L (PHYSPROP Database, 2011)) and its acute toxicity is "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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