GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 924-42-5
Chemical Name N-Methylolacrylamide
Substance ID R03-C-067-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2010  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 -
-
-
- - -
2 Flammable gases -
-
-
- - -
3 Aerosols -
-
-
- - -
4 Oxidizing gases -
-
-
- - -
5 Gases under pressure -
-
-
- - -
6 Flammable liquids -
-
-
- - -
7 Flammable solids -
-
-
- - -
8 Self-reactive substances and mixtures -
-
-
- - -
9 Pyrophoric liquids -
-
-
- - -
10 Pyrophoric solids -
-
-
- - -
11 Self-heating substances and mixtures -
-
-
- - -
12 Substances and mixtures which, in contact with water, emit flammable gases -
-
-
- - -
13 Oxidizing liquids -
-
-
- - -
14 Oxidizing solids -
-
-
- - -
15 Organic peroxides -
-
-
- - -
16 Corrosive to metals -
-
-
- - -
17 Desensitized explosives -
-
-
- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) -
-
-
- - -
1 Acute toxicity (Dermal) -
-
-
- - -
1 Acute toxicity (Inhalation: Gases) -
-
-
- - -
1 Acute toxicity (Inhalation: Vapours) -
-
-
- - -
1 Acute toxicity (Inhalation: Dusts and mists) -
-
-
- - -
2 Skin corrosion/irritation -
-
-
- - -
3 Serious eye damage/eye irritation -
-
-
- - -
4 Respiratory sensitization -
-
-
- - -
4 Skin sensitization -
-
-
- - -
5 Germ cell mutagenicity -
-
-
- - -
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)).
7 Reproductive toxicity -
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-
- - -
8 Specific target organ toxicity - Single exposure -
-
-
- - -
9 Specific target organ toxicity - Repeated exposure -
-
-
- - -
10 Aspiration hazard -
-
-
- - -

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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