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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	2579-20-6
Chemical Name	1,3-Bis(aminomethyl)cyclohexane
Substance ID	24A6130
Classification year (FY)	FY2012
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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point of 106 deg C [closed-cup] (MSDS (Sigma-Aldrich) (Access on Oct. 2012)) is above 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	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).
13	Oxidizing liquids	Not applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

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	It was classified in Category 4 based on LD50 values for rats of > 300-2,000 mg/kg (OECD TG423) (JECDB (2007)) and 200-2,000 mg/kg (OECD TG 401) (NICNAS (2001)).
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	It was classified in Category 4 based on an LD50 value of 1,700 mg/kg for rabbits (OECD TG) (NICNAS (2001)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Category 1A	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In a skin irritation test in which 0.5 mL of the test substance was applied to one rabbit for 3 minutes, Draize irritation scores after 1 hour were 4 for erythema and 0 for edema, and green-colored necrosis, loss of elasticity, and dryness were observed in the skin, and it was assessed to be corrosive (NICNAS (2001)). Therefore, it was classified in Category 1A.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It was classified in Category 1 because this substance was corrosive to the rabbit skin (NICNAS (2001)), and it was corrosive to the skin.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Not classified	- -	-	-	It was classified as "Not classified" because the positive rate was 0% (0/10) in a maximization test with guinea pigs (OECD TG406), and it was not sensitizing (NICNAS (2001)).
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after oral administration to mice (in vivo somatic cell mutagenicity test) (JECDB (Access on Oct. 2012)). Besides, as for in vitro tests, it is reported that it was negative in an Ames test (JECDB (2006)) and positive in a chromosomal aberration test with Chinese hamster CHL cells (JECDB (2006)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats (OECD TG 422), parent animals showed general toxicity such as salivation, reduced weight gain (males), and lesions in the stomach on pathological examination in the high dose group (300 mg/kg), but there were no abnormalities in estrous cycle, copulation index, fertility index, delivery index, gestation length, the number of corpus lutea, the number of implantations, implantation index, gestation index, and parturition and lactation behavior, and as for neonates, no changes related to the test substance were observed in the number of offspring born, live birth index, sex ratio, viability index on day 4, external appearance, general conditions, body weights, and necropsy (JECDB (2007)). From the above results, it was judged that there were no adverse effects on sexual function/fertility. However, due to lack of data on effects on the development of offspring including teratogenicity, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 2 (systemic toxicity)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In a single oral administration test with rats (OECD TG 423) (doses: 300, 2,000 mg/kg bw), there were no deaths at 300 mg/kg, and no changes related to the test substance were observed in general conditions, body weights, or necropsy. However, at 2,000 mg/kg, hypoactivity, ptosis, hypothermia, irregular respiration, bradypnea, and abnormal body position (prone position, supine position, crouching position) were found, all the animals died by two days after the administration, and necropsy revealed reddish changes and edema in the forestomach and glandular stomach, and accumulation of abnormal contents in the gastrointestinal tract (JECDB (2007)). The above findings were within the guidance value range for Category 2, but because it was hard to specify the target organ, it was classified in Category 2 (systemic toxicity). Besides, the lesions in the stomach were considered to be local effects due to irritation by oral administration of a corrosive substance and were not used for classification.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats (OECD TG 422) (doses: 10, 60, 300 mg/kg/day), in the 300 mg/kg group (converted guidance value: about 150 mg/kg/day), death of one male, reduced weight gain, and salivation were observed, and pathological examination revealed lesions in the stomach such as focal hyperplasia and hyperkeratosis in the squamous epithelium in the forestomach, and atrophy of the seminiferous tubules in males. Furthermore, increases in reticulocyte counts and leukocyte counts, decreased total protein, increases in ALAT (GPT) and ALP activities, and increased weights of the kidney and adrenal gland were seen in the 300 mg/kg group, and the NOEL was reported to be 60 mg/kg/day (converted guidance value: about 30 mg/kg/day) (JECDB (2007)). And in a 28-day repeated oral administration test with rats (OECD TG 407) (doses: 0, 50, 250, 1,000 mg/kg/day), decreased food consumption and reduced weight gain, as well as weight changes of the brain, spleen, and liver, were observed in the high dose group (1,000 mg/kg/day, converted guidance value: 311 mg/kg/day), but there were no visual or microscopic findings suggesting toxicity, and the NOEL was reported to be 250 mg/kg/day (converted guidance value: about 77.8 mg/kg/day) (NICNAS (2001)). From the results of the above two tests, there were no findings to show adverse effects at doses within the guidance value range, and it corresponds to "Not classified" in the oral route. However, because effects are unknown in the other routes due to no data, it was classified as "Classification not possible" for this hazard class.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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