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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1477-55-0
Chemical Name	m-Xylylenediamine
Substance ID	24B6501
Classification year (FY)	FY2012
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)	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 113 deg C [closed-cup] (MSDS (Sigma-Aldrich, 2010)) 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	- -	-	-	There is the information that it attacks many metals (IMDG (2010)), and that aluminum is an unsuitable material for containers (GESTIS (Access on Apr. 2012)). However, due to no test data on the corrosion rate, the classification is not possible.

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	There are reports on five LD50 values for rats of 930 mg/kg, 660 mg/kg (above ACGIH (2001)), 980 mg/kg (females), 1,090 mg/kg (males), and 1,180 mg/kg (above SIDS (Access on Apr. 2012)), all of which correspond to Category 4. Therefore, it was classified in Category 4.
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Two LD50 values for rabbits of 2,000 mg/kg (ACGIH (2001)) and > 2,000 mg/kg (SIDS (Access on Apr. 2012)) are reported, one of them corresponds to Category 4, and the other corresponds to "Not classified" including "Not classified" in the Classification JIS. It was classified in Category 4 by adopting a more hazardous category.
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)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	LC50 values for rats by 4-hour exposure are reported to be >1.42 mg/L for males and 0.8 mg/L for females (Directive 84/449/EEC, B.2.; GLP-compliant) (SIDS (Access on Apr. 2012)), corresponding to Category 4 or "Not classified" for males and Category 3 for females. It was classified in Category 3 by adopting a more hazardous category for females.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	IIn tests in which 1 mL/kg b.w. of undiluted this substance was applied to rats and mice for 4 hours, necrosis appeared after 5 minutes for rats and 10-20 minutes for mice, necrosis was very severe, and it was assessed as corrosive for both animal species (SIDS (Access on Apr. 2012)). Therefore, it was classified in Category 1. Besides, it was reported to be corrosive also in tests with rabbits or guinea pigs, although the details are unknown (ACGIH (2001), SIDS (Access on Apr. 2012)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It was classified in Category 1 because it was classified as corrosive in skin corrosion/irritation.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	In a maximization test with guinea pigs (Directive 92/69/EEC Method B6: GLP-compliant), a positive rate was 70% (7/10), and it was concluded that it was classified as a strong sensitizer (SIDS (Access on Apr. 2012)). Therefore, it was classified in Category 1. Besides, this substance was reported as a potent dermatologic sensitizer of workers in plastic manufacturing (ACGIH (2001)), and an Sh mark was assigned as a skin sensitizer by DFG (Deutsche Forschungsgemeinschaft) (MAK/BAT (2011)).
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) (SIDS (Access on Apr. 2012)). Besides, as for in vitro mutagenicity tests, it is reported that it was negative in both an Ames test and a chromosomal aberration test with Chinese hamster CHL/IU cells (JECDB (1994)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a reproduction/developmental toxicity screening test by oral administration to rats (OECD TG421; GLP-compliant), parent animals showed general toxicity such as deaths, salivation, irregular respiration, abdominal distention and reduced weight gain, and pathological findings of various changes in the stomach (including forestomach ulcers and proliferation of the squamous epithelium) at or above the middle dose (150 mg/kg) or at the high dose (450 mg/kg). On the other hand, as for reproductive toxicity, no anomalies were observed in copulation ability, fertility, estrous cycle, and parturition status, and no abnormalities were found in the external examination of neonates (JECDB (2000)). Therefore, it was estimated that there were no adverse effects on sexual function/fertility, but there were no data on the examination of fetuses at the end of gestation. Due to insufficient 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 1 (lung), Category 2 (systemic toxicity)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	It is reported that in an acute toxicity test by 4-hour inhalation exposure (mist) of rats (Directive 84/449/EEC, B.2. GLP-compliant), various degrees of inflammatory changes in the lung such as bronchiolitis, alveolar macrophage aggregation, occasionally, exudative inflammation were observed in many animals at concentrations of 0.74 mg/L or above (SIDS (Access on Apr. 2012)). Furthermore, it is described that in another test by 1-hour inhalation exposure to concentrations of 1.74-6.04 mg/L of rats (mist; converted 4-hour equivalent value 0.435-1.51 mg/L), macroscopic abnormalities were found primarily in the lung (ACGIH (2001)). Because effects occurred at a concentration range corresponding to the guidance values for Category 1, it was classified in Category 1 (lung). On the other hand, in acute oral toxicity tests with rats and mice (LD50 value: rats 980-1,090 mg/kg, mice 1,180 mg/kg), the decline of spontaneous movement, and blepharoptosis were seen, and ataxia and oppression in breathing occurred additionally in dead animals. Doses were estimated to correspond to the guidance values Category 2 from the LD50 values, but because it was hard to specify the target organ, it was classified in Category 2 (systemic toxicity). Besides, tissue damage in the digestive organs was observed after oral administration, but they were not adopted as the target organ by judging that it was a local effect of the corrosivity of this substance.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day repeated oral administration test with rats, there is a report on the occurrence of signs such as decreased locomotor activity and deaths, pathological changes of ulceration in the mucous membranes primarily in the forestomach portion, hyperplasia of the stratified squamous epithelium in the stomach, and decreases in hemoglobin and hematocrit values, a decrease in serum total protein, etc. in blood or biochemical tests at the highest dose of 600 mg/kg/day (converted guidance value: 187 mg/kg/day), but no toxicity effects were reported at or below 150 mg/kg/day, the next lower dose (JECDB (1994)). On the other hand, in a reproduction/developmental toxicity screening test by oral administration to rats from 2 weeks before mating, throughout the mating and gestation period, until lactation day 3 (OECD TG421; GLP-compliant), deaths and signs also occurred, but no effects were reported except for changes in the stomach such as forestomach ulcers and proliferation of the squamous epithelium observed at the highest dose of 450 mg/kg (converted guidance value: 225 mg/kg/day) (JECDB (2000)). From the above, the primary toxicity was disorders in the mucous membranes in the stomach and changes accompanying them, but they were not adopted for the rationale for classification because this substance is corrosive and the changes in the stomach were estimated to be local effects on oral administration of this substance. Furthermore, because they were the effects at doses above the guidance value range, 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 specific target organ toxicity (repeated exposure).
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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 15 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2009)).
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (not readily degradable (a 4-week degradation rate by BOD: 22%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and 21-day NOEC = 4.7 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (not readily degradable (a 4-week degradation rate by BOD: 22%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and 96-hour LC50 = 75 mg/L for fish (Leuciscus idus) (SIDS, 2003). By drawing a comparison between the above results, it was classified in Category 3.
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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