NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	924-42-5
Chemical Name	N-Methylolacrylamide
Substance ID	m-nite-924-42-5_v2
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	- -	-	-	There are chemical groups (unsaturated bond) present in the molecule associated with self-reactive properties. 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	Classification not possible	- -	-	-	No data available.	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 (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	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 rat LD50 value of 563 mg/kg bw (NTP TR 352 (1989)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit LD50 value of approximately 16000 mg/kg bw (NTP TR 352 (1989)), the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	The rat LC50 value of > 0.319 mg/L/6hrs (= 0.478 mg/L/4hrs) was reported (IUCLID (2000)). This data did not provide information to specify an appropriate category, thus, the classification was not possible. Since the test concentration (0.319 mg/L) was higher than the saturated vapor pressure concentration (0.001 mg/L), it was judged that the substance state was dust.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	In the rabbit test, the substance caused mild to marked irritation after 24-hour application of 2,000 - 16,000 mg/kg (NTP TR352 (1989)). In this study, however, the substance was used with extremely high dose and the application time is longer than four hours. Because it was suggested that milder irritation would be detected in the ordinary test method, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 3 in the UN-GHS classification).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	The substance was classified as Category 2 based on the documented case of "mild to marked irritation" resulted from rabbit test (NTP TR352 (1989)). In another rabbit test, instillation of 3 mg of the test substance to conjunctival sac caused slightly irritating (IUCLID (2000)).	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	- -	-	-	No data available.	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 the negative results in the micronucleus test using bone marrow cells obtained from mice orally or intraperitoneally administered (in vivo mutagenicity test in somatic cells) (NTP DB (Access on Jul. 2010)). As relevant information, as for in vitro studies, negative results in the Ames test, and positive results in the chromosome aberration test using CHO cells were reported (NTP DB (Access on Jul. 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), although it was with one animal species (mice) in a proper test, since an increase in the incidence of tumors including malignant ones in both males and females (alveolar-bronchiolar adenomas and carcinomas (combined) in males and females) was observed and it was judged that there was sufficient evidence for carcinogenicity in animal tests, it was classified in Category 1B. Based on a new evaluation, the classification result was changed. [Evidence Data] (1) It was reported that, in a two-year oral administration test using mice, with doses of 25 mg/kg/day and 50 mg/kg/day, the incidences of tumors of the Harderian gland (adenomas in males and females), the liver (hepatocellular adenomas and carcinomas (combined) in males, hepatocellular adenomas in females), the lung (alveolar/bronchiolar adenomas and carcinomas (combined) in males and females), and the ovary (benign granulosa cell tumors in females) increased (NTP TR352 (1989), IARC 60 (1994), CLH report (2017)). (2) From (1), the NTP and the EU concluded that there was clear evidence in mice for the carcinogenicity and the IARC concluded that there was limited evidence in mice for the carcinogenicity (NTP TR352 (1989), IARC 60 (1994), CLH report (2017)). (3) As for the classification results by domestic and international evaluation organizations, the IARC classified it in Group 3 (IARC 60 (1994)) since there was limited evidence in experimental animals and there were no findings in human based on (1), and the EU classified it in Carc. 1B (EU-CLP Classification Results (Accessed Jan. 2022)) based on (1), and additionally, since acrylamide (CAS RN 79-06-1), which is a structural analog, has been classified in Carc. 1B. [Reference Data, etc.] (4) It was reported that, in a two-year oral administration test using rats, with doses of up to 12 mg/kg/day, no carcinogenic effects were observed (NTP TR352 (1989), IARC 60 (1994), CLH report (2017)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In the two-generation study in mice by oral administration in accordance with the protocol of reproductive assessment by continuous breeding (RACB), no apparent systemic toxicity was seen in F0 generation. In F0 and F1 generations, the decreased pups per litter, prolongation of inter-litter interval and increased postimplantation loss were seen. It was concluded that the exposure of the test substance produced the moderate reproductive toxicity (NTP RACB 90017 abstract (1993)). Moreover, it was also presumed that since this substance has a dominant-lethal effect, all of the reproductive toxicity in F0 generation might be related to the dominant lethal effects (NTP RACB 90017 abstract (1993)). As mentioned above, because reproductive effects were noted at the doses that were not shown general toxicity in parental animals, the substance was classified as Category 1B.	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	It was reported that the substance induced peripheral neuropathy of the same type as that induced by acrylamide in both rats and mice (IARC 60 (1994)). And it was also reported that ataxia, loss of pain and righting reflexes, and mild tonic and clonic convulsions prior to death were observed at the dose levels within the range of LD50 (350 - 510 mg/kg) following oral administration to mice (IUCLID (2000)). Thus, the substance was classified as Category 2 (nervous system). In addition, no adverse effects were described at the doses within the range of the guidance values in both inhalation and dermal routes (IUCLID (2000)).	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 13-week repeated dose oral toxicity studies in rats and mice, as for rats, hind limb ataxia was observed and progressed to hind limb paralysis in 50 mg/kg/day or more. In the neurobehavioral assessments, decreased grip strength of forelimb and hind limb as well as decreased startle response was seen at the doses of 12.5 mg/kg/day or higher, and increased incidence of degeneration of axonema and myelin sheath in the brain stem, spinal cord and peripheral nerves was seen at 25 mg/kg/day and higher (NTP TR352 (1989)). In mice, decreased grip strength of forelimb was seen at the doses of 25 mg/kg/day and higher, and exaggerated startle response and reduction in muscle coordinated movements were seen at 100 mg/kg/day (NTP TR352 (1989)). Since the effects described above were observed at the doses equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (nervous system). In addition, in above 13-week repeated oral dose study in rats, distension of urinary bladder, inflammation, hemorrhage and edema of mucous membrane of the urinary bladder were observed at 25 mg/kg/day or higher. However, because there was a description in the report stating that these lesions were probably a secondary effect (NTP TR 352 (1989)), the information was not adopted for the evidence of classification.	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 = 356 mg/L for fish (Oncorhynchus mykiss) (IUCLID, 2000).	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 its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility = 653 g/L (PHYSPROP Database, 2011)).	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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