NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	101-61-1
Chemical Name	4,4'-Methylenebis(N,N-dimethylaniline)
Substance ID	R01-B-096
Classification year (FY)	FY2019
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	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	There is information that it is combustible (GESTIS (Access on September 2019)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because 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	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for mice: 3,160 mg/kg (DFGOT vol.1 (1991), HSDB (Access on October 2019)) [Reference Data, etc.] (2) LDLo for rats: 500 mg/kg (DFGOT vol.1 (1990))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] There is a description in (1), however, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) This substance may be irritating to the eyes, skin and mucous membranes, but there are no data in humans or experimental animals to confirm this (GESTIS (Access on October 2019)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] There is a description in (1), however, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) This substance may be irritating to the eyes, skin and mucous membranes, but there are no data in humans or experimental animals to confirm this (GESTIS (Access on October 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, positive results were reported in bacterial reverse mutation tests and mouse lymphoma assays, and a negative result was reported in a chromosomal aberration test (DFGOT vol.1 (1991), NTP DB (Access on October 2019)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1B. The classification result was changed by considering the revision of the GHS classification guidance for the Japanese Government and the results in experimental animals. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as R by NTP (NTP RoC (14th, 2016)), as B2 by EPA (IRIS (1989)) and in Carc.1B in EU CLP (EU CLP classification (Access on October 2019)). In addition, IARC concluded that there is sufficient evidence in experimental animals for the carcinogenicity of this substance (Michael's base) (IARC 99 (2010)). (2) On administration by feeding of this substance, increased incidences of follicular cell carcinomas of the thyroid in rats of both sexes, and increased incidences of a combination of benign hepatocellular adenomas and malignant hepatocellular carcinomas in mice of both sexes, were noted (NTP TR186 (1979)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Category 2 (thyroid)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2 (thyroid). As a result of reviewing information from the information sources and considering the classification, the classification result was changed from the previous classification. [Evidence Data] (1) In a 59-week repeated dose toxicity test with rats dosed by feeding, follicular cysts of the thyroid in males and females and decreased body weight and hyperplasia of the thyroid in females at or above 375 ppm (converted guidance value: 18.75 mg/kg/day, within the range of Category 2) and decreased body weight and hyperplasia of the thyroid in males at 750 ppm (converted guidance value: 37.5 mg/kg/day, within the range of Category 2) were observed (NTP TR186 (1979)). [Reference Data, etc.] (2) In a 4-week repeated dose toxicity test with rats dosed by feeding, reduced body weight gain in males at or above 315 ppm (converted guidance value: 4.9 mg/kg/day, within the range of Category 1), reduced body weight gain in females at or above 680 ppm (converted guidance value: 10.6 mg/kg/day, within the range of Category 2), and rough hair and arched backs in females at 3,155 ppm (converted guidance value: 49 mg/kg/day, within the range of Category 2) were observed (NTP TR186 (1979), DFGOT vol.1 (1991)). (3) In a 78-week repeated dose toxicity test with mice dosed by feeding, at or above 1,250 ppm (converted guidance value: 187.5 mg/kg/day, exceeding Category 2), increased incidences of papillary and focal hyperplasia in the thyroid were observed (NTP TR186 (1979), DFGOT vol.1 (1991)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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.

To GHS Information