NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1761-71-3
Chemical Name	4,4'-Methylenebis(cyclohexan-1-amine)
Substance ID	m-nite-1761-71-3_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. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" from a flash point of 159 deg C (closed cup) (GESTIS (Access on September 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 380 mg/kg (SIDS (2016), REACH registration dossier (Access on October 2019)) (2) LD50 for rats: >670-<1,000 mg/kg (SIDS (2016), REACH registration dossier (Access on October 2019))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: 2,110 mg/kg (SIDS (2016)) (2) LD50 for rabbits: > 1,000 mg/kg, no death cases (SIDS (2016))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1B	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1B-C. [Evidence Data] (1) In a skin irritation test with rabbits according to OECD TG 404, the 3-minute exposure did not result in necrosis at the 1-hour observation period, but one out of three animals exhibited necrosis at the 24-hour observation. The 2.75-hour exposure resulted in necrosis by the 1-hour post exposure observation (REACH registration dossier (Access on November 2019)). (2) This substance is considered to be severely irritating to corrosive to the skin and eyes (GESTIS (Access on September 2019)). (3) This substance is also considered to be corrosive since all of its analogues are corrosive substances (SIDS (2016)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1)-(4), it was classified in Category 1. [Evidence Data] (1) In an eye irritation test in which this substance (0.01 mL) was applied to the eyes of rabbits, dense corneal scarring, inflammation and lenticular opacity, etc. were observed and it was judged to be a corrosive substance (REACH registration dossier (Access on November 2019)). (2) This substance is considered to be severely irritating to corrosive to the skin and eyes (GESTIS (Access on September 2019)). (3) This substance is considered to be corrosive (SIDS (2016)). (4) This substance was classified as Skin corrosion (Category 1).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Although there are Data in (1) and (2), these are insufficient data for classification. Therefore, it was classified as "Classification not possible." [Reference Data, etc.] (1) In a skin sensitization test with guinea pigs, it was judged to be a weak sensitizer (REACH registration dossier (Access on November 2019)). (2) Since similar compounds of this substance did not show sensitization, this substance is also expected to lack a sensitizing potential (SIDS (2016)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] According to (1) and (2), based on the weight of the evidence, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, negative or positive results are reported in mouse micronucleus tests by a single intraperitoneal injection (SIDS (2016)). (2) As for in vitro, negative results are reported in bacterial reverse mutation tests, a chromosome aberration test and a gene mutation test with cultured mammalian cells (SIDS (2016), NTP DB (Access on September 2019), REACH registration dossier (Access on November 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, reproductive and developmental effects (a reduced number of implantation sites, decreased gestation index, and a reduction in the viability index, etc.) were observed at doses where general toxicity (vacuolation of the stomach musculature, centrilobular vacuolation of the liver, vacuolar myofiber degeneration of the skeletal muscle, and vacuolation of the cuboidal epithelium of the iris of the eyes, etc.) was observed in parental animals (SIDS (2016)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] There are no reports on single exposure to this substance in humans. Based on information in (1) in experimental animals, it was classified in Category 2 (central nervous system). [Evidence Data] (1) There is a description that in a single oral dose study with rats, piloerection, conversions, lethargy, and a comatose appearance were observed at or above 562 mg/kg in males and at or above 398 mg/kg in females (both are corresponding to Category 2) (SIDS (2016), REACH registration dossier (Access on October 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (central nervous system, eye, liver, muscle, gastrointestinal tract)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2 (central nervous system, eye, liver, muscle, gastrointestinal tract). [Evidence Data] (1) As a result of a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats, clinical signs (hunched posture, yellow feces, piloerection, lean appearance, ptosis, lethargy, chromodacryorrhoea, rales, etc.), increased AST, reduced creatinine, vacuolation of the stomach musculature, centrilobular vacuolation of hepatocytes, degeneration of the skeletal muscle, vacuolation of the cuboidal epithelium of the iris, etc. were observed at or above 50 mg/kg/day (converted guidance value: male: 20 mg/kg/day; female: 27 mg/kg/day, within the range of Category 2), and effects on the brain (vacuolation of the choroid plexus) were observed at 100 mg/kg/day (converted guidance value: male: 40 mg/kg/day; female: 53 mg/kg/day, within the range of Category 2) (SIDS (2016)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 6.84 mg/L for crustacea (Daphnia magna) (SIDS, 2016, Environmental Risk Assessment for Chemical Substances Vol. 15 (Ministry of the Environment, 2017)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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