GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 1761-71-3
Chemical Name 4,4'-Methylenebis(cyclohexan-1-amine)
Substance ID R01-A-025
Classification year (FY) FY2019
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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)  
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 *
-
-
- - Liquid (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 *
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5 Gases under pressure *
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6 Flammable liquids *
-
-
- - It was classified as "Not classified" from a flash point of 159 deg C (closed cup) (GESTIS (Access on September 2019)).
7 Flammable solids *
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8 Self-reactive substances and mixtures *
-
-
- - There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9 Pyrophoric liquids *
-
-
- - No data available.
10 Pyrophoric solids *
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11 Self-heating substances and mixtures *
-
-
- - Test methods applicable to liquid 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 *
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - Liquid (GHS definition). 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 *
-
-
- - No data 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) 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))
1 Acute toxicity (Dermal) *
-
-
- - [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))
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 Category 1B-C
-
-
- - [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)).
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).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [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)).
5 Germ cell mutagenicity *
-
-
- - [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)).
6 Carcinogenicity *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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)).
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)).
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)).
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) 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)).
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.
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.

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