NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1477-55-0
Chemical Name	m-Xylylenediamine
Substance ID	R02-B-009-MHLW, MOE
Classification year (FY)	FY2020
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 FY2012
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" from a flash point of 142 deg C (closed cup) (GESTIS (Access on April 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
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."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Besides, there is information that aluminum is an unsuitable material (GESTIS (Access on April 2020)).
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	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] It was classified in Category 4 from (1), (2). [Evidence Data] (1) LD50 for rats: 660 mg/kg (ACGIH (7th, 2019)) (2) LD50 for rats: 930 mg/kg (ACGIH (7th, 2019), GESTIS (Access on April 2020), REACH registration dossier (Access on May 2020))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] It was classified in Category 4 from (1). [Evidence Data] (1) LD50 for rabbits: 2,000 mg/kg (ACGIH (7th, 2019), GESTIS (Access on April 2020))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1), (2). Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (0.220 mg/L), a reference value in the unit of mg/L was applied as mist. [Evidence Data] (1) LC50 for rats (4 hours): males: > 1.42 mg/L, females: 0.8 mg/L (SIAP (2001)) (2) LC50 for rats (4 hours, aerosol): 1.34 mg/L (REACH registration dossier (Access on May 2020)) (3) Vapor pressure of this substance: 0.03 mmHg (25 deg C) (converted value for the saturated vapor pressure concentration: 0.220 mg/L) (HSDB (Access on April 2020))
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	[Rationale for the Classification] It was classified in Category 1 from (1), (2). [Evidence Data] (1) Undiluted this substance was corrosive to the guinea pig skin, and a 50% emulsion in acetone/dioxane was severely irritating, but a 10% emulsion produced little effect. And a topical application of a 10% aqueous solution caused severe erythema and edema (ACGIH (7th, 2019)). (2) This substance is corrosive to the rat and mouse skin (SIAP (2001), REACH registration dossier (Access on May 2020)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1). [Evidence Data] (1) This substance was classified in Category 1 in skin corrosion/irritation.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1A from (1) - (5). [Evidence Data] (1) This substance was assigned as occupational skin sensitizers Group 1 by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), September 2019)). (2) This substance was a sensitizer in a skin sensitization test with guinea pigs (maximization test) (SIAP (2001)). (3) This substance was reported to be a potent dermatologic sensitizer of workers in plastics manufacturing (ACGIH (7th, 2019)). (4) This substance causes skin sensitization in workers at concentrations equal to and below 0.1 mg/m3 (SIAP (2001)). (5) It was determined to be positive in a mouse local lymph node assay (LLNA) according to TG429 (REACH registration dossier (Accessed on October 2019)). [Reference Data, etc.] (6) Mild sensitization was found following repeated application of this substance to guinea pigs, but this could not be duplicated (ACGIH (7th, 2019)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a micronucleus test with mouse bone marrow cells (ACGIH (7th, 2019), SIAP (2001)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test and a chromosomal aberration test with cultured mammalian cells (ACGIH (7th, 2019), SIAP (2001), JECDB (Access on April 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] No data available.
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was generally judged that this substance has no harmful effects on sexual function/fertility and development and it was classified as "Not classified." Since the new information was obtained, the classification result was changed from the previous classification. [Evidence Data] (1) In a reproduction toxicity screening study with rats dosed by gavage (OECD TG 421), even at a dose at which toxicity effects (death, reduced body weight gain, a decrease in food consumption, forestomach lesions (ulcer, hyperplasia of the squamous epithelium with hyperkeratosis, etc.)) were observed in parental animals, no effect on fertility or pups was observed (JECDB (Access on April 2020)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 19 of gestation (OECD TG 414), even at a dose at which toxicity effects (a decrease in body weight, sacrifice in emergency (3/25 cases), labored respiration, dark red discoloration of the lungs, etc.) were observed in dams, no effect was observed in embryos/fetuses (REACH registration dossier (Access on June 2020)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (3), the main acute effects of this substance were considered to be effects on the respiratory organs caused by its corrosiveness. Therefore, this substance was classified in Category 1 (respiratory organs). In the previous classification, a decrease in locomotor activity and blepharoptosis that were observed in acute oral toxicity tests with rats and mice, and ataxia and labored breathing that were observed in dead animals were adopted as the basis for the classification. However, as the effects such as a decrease in locomotor activity and blepharoptosis were recoverable and the ataxia and labored breathing were observed in dead animals, these findings were not adopted as the basis for the classification, and the classification result was changed from the previous classification. [Evidence Data] (1) The toxicity of this substance was due to its corrosiveness at the site of first contact (SIAP (2001)). (2) As a result of inhalation exposure of rats to an aerosol of this substance at 1.74 to 6.04 mg/L for one hour (converted 4-hour equivalent value: 0.44 to 1.51 mg/L, within the range for Category 1 to Category 2), ocular irritation, lacrimation, and dyspnea were observed, and at necropsy, lesions in the lungs were observed (ACGIH (7th, 2019)). (3) In an acute inhalation toxicity test with rats exposed to an aerosol of this substance at 0.74 to 5.2 mg/L for 4 hours (OECD TG 403), at 0.74 mg/L (within the range for Category 1), accelerated respiration, pulmonary respiration sounds, squatting posture, piloerection and contaminated fur were observed; and at necropsy, diffuse red discoloration and edema of the lung lobes were observed in surviving animals in the 0.74 mg/L group and diffuse red discoloration of the lung lobes was observed in dead animals in the groups at or above 1.35 mg/L (REACH registration dossier (Access on May 2020)). [Reference Data, etc.] (4) It was reported that in a case study with workers at a manufacturing plant of this substance, irritation of the gastrointestinal tract caused by the caustic nature of this substance was observed (ACGIH (7th, 2019)). (5) In acute oral toxicity tests with rats and mice, symptoms such as a decline of locomotor activity and blepharoptosis were observed several hours after the administration but disappeared after 3 to 7 days. Animals that died during observation showed ataxia and labored breathing before their death. At necropsy, intense ulceration or necrosis was observed in the stomach and intestinal tract of dead animals, but no extreme changes were observed in any other organs (REACH registration dossier (Access on May 2020))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1), in an inhalation exposure test with experimental animals, effects on the respiratory organs were observed at doses within the range for Category 1. Therefore, the substance was classified in Category 1 (respiratory organs). The classification was conducted based on the new information, and the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that in an inhalation exposure test with rats by nasal exposure to an aerosol of this substance for 13 weeks (6 hours/day, 5 days/week), degeneration of the bronchial epithelium (loss of cilia, attenuation of the epithelium, increased cytoplasmic basophilia, pyknotic nuclei) were observed at or above 5 mg/m3 (converted guidance value: 0.004 mg/L, within the range for Category 1) and squamous metaplasia in the bronchial epithelium and subacute inflammation of the lungs were observed at 30 mg/m3 (converted guidance value: 0.022 mg/L, within the range for Category 2) (REACH registration dossier (Access on May 2020)). [Reference Data, etc.] (2) It was reported that in a 28-day repeated dose toxicity study with rats by oral administration, at 600 mg/kg/day (converted guidance value: 187 mg/kg/day, exceeding Category 2), symptoms such as a decrease in locomotor activity appeared and death occurred, and pathological changes such as ulceration and hyperplasia of the stratified squamous epithelia were observed in the stomach, mainly in the forestomach mucosa. Furthermore, in blood or biochemical tests, decreases in hemoglobin and hematocrit, a decrease in total serum protein, etc. were reported. At a lower dose of 150 mg/kg/day or below, no toxicity effects were reported (JECDB (Access on April 2020), SIAP (2001)).
10	Aspiration hazard	Classification not possible	- -	-	-	[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 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 Environment Agency in Japan (Environment Agency, 1999)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" because it was not rapidly degradable (a 4-week degradation rate by BOD: 22% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1984)) and due to 21-day NOEC = 4.7 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999), SIAP, 2001). 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 because it was not rapidly degradable (a 4-week degradation rate by BOD: 22% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1984)) and due to 96-hour LC50 = 75 mg/L for fish (Leuciscus idus) (SIAP, 2001). 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.
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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