NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	124-09-4
Chemical Name	Hexamethylenediamine
Substance ID	23B5516
Classification year (FY)	FY2011
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 & 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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	There is information that it is combustible (Weiss (1986)), but the classification is not possible due to no data.
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	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 305 deg C (ICSC (1998)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Besides, it is described in ICSC (J) (1998) that it attacks many metals in the presence of water. And it is classified as corrosive in UNRTDG (UN2280), but because the classification includes skin corrosion, it was impossible to judge whether it is corrosive to metals.

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	All five LD50 values for rats (980 mg/kg, 792 mg/kg, 1,127 mg/kg, 800 mg/kg, 750 mg/kg) (SIDS (Access on Oct. 2011)) correspond to Category 4.
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 1,110 mg/kg bw for rabbits (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	There is a report on an LC50 value of > 0.95 mg/L (4 hours, dust) for rats (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)), but because the category cannot be determined with this value, it was classified as "Classification not possible" due to lack of data.
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	Pain reactions were observed within one minute after application of the test substance containing 85% of this substance to the skin of three rabbits, and erythema with small vesicles was seen immediately after the removal of the patch (after 15 minutes) (SIDS (Access on Oct. 2011)). Furthermore, as a result of the 24-hour application of the powders of the test substance to three rabbits, the irritation score was 8 for all three animals at all observation points (maximum 8), and it was judged as corrosive (USEPA/HPV (2003), corresponding to List 1). From the above, it was classified in Category 1. Besides, it is described that the pH of this substance (100 g/L an aqueous solution) was 12.4 (GESTIS (Access on Sept. 2011)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It was classified in Category 1 because extreme irreversible irritation occurred in a test in which 0.1 mL of a 25% aqueous solution was applied to the rabbit eye for 30 seconds, and the irritation score was 110 (/110) at all observation points (USEPA/HPV (2003)). Besides, it is described that the pH of this substance (100 g/L an aqueous solution) was 12.4 (GESTIS (Access on Sept. 2011)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available. Besides, it is described that signs typical of pulmonary sensitization were observed in guinea pigs that received an injection and subsequent exposure to saturated vapours (ACGIH (2001)), although details are unknown.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	In humans, it is reported that an eruption occurred after wearing underwear, and as a result of solvent fractionation and patch testing of detected components, the person had a positive reaction to hexamethylenediamine and was diagnosed with allergic contact dermatitis (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)), and it is listed as an allergen in Contact Dermatitis (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1). Therefore, it was classified in Category 1. Besides, a negative result was reported in a skin sensitization test with guinea pigs (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)).
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" because it was reported to be negative in both in vivo somatic cell mutagenicity tests of a chromosomal aberration test with bone marrow cells after oral administration to rats (USEPA/HPV (2003)) and a micronucleus test with mouse peripheral blood (ACGIH (2001)). Besides, as for in vitro tests, it was reported to be negative in all of an Ames test (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)), a chromosomal aberration test with Chinese hamster CHO cells (NTP DB ID780219 (1982)), and a gene mutation test with Chinese hamster CHO/K1 cells (USEPA/HPV (2003)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation reproductive test by oral administration to rats (GLP-compliant), both F0 and F1 showed a decrease in litter size at a dose where reduced weight gain was seen in F0 and F1 paternal animals (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)). Therefore, it was classified in Category 2. Besides, in developmental toxicity tests (GLP: yes) by oral administration to rats during a gestation period, including the organogenesis period, no effects on the development of offspring, including teratogenicity, were observed at doses where reduced weight gain was found in maternal animals (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008), SIDS (Access on Oct. 2011)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs), Category 2 (systemic toxicity)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	It is reported that in humans, this substance is corrosive to the eye, skin, and respiratory tract, and inhalation causes a burning sensation, cough, labored breathing, shortness of breath, and sore throat (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), and in a test in which rats were given 6-hour inhalation exposure to the vapour of this substance at 2100 ppm (9.984 mg/L) two times (converted 4-hour equivalent value: 17.293 mg/L), nasal irritation reaction, dyspnea, lethargy, bronchitis, pulmonary edema, and lung hemorrhage were seen (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)). Because there is knowledge in humans, it was classified in Category 1 (respiratory system). Furthermore, after oral administration of 500, 700, 800, 1,000 mg/kg bw to rats, signs such as muscle weakness, soiled perineal region and face, alopecia, and diarrhea were observed, death occurred at or above 700 mg/kg, and an LD50 value was reported to be 792 mg/kg (USEPA/HPV (2003)). Because doses were within the guidance value range for Category 2, and it was impossible to specify the target organ, it was classified in Category 2 (systemic toxicity).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory tract)	Danger	H372	P260 P264 P270 P314 P501	Irritation of the conjunctiva and upper respiratory tract was reported in a survey on 20 workers exposed to this substance (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), and it is described that dermal and upper respiratory irritation is the major finding associated with exposure to this substance in humans (ACGIH (2001)). Furthermore, in an animal test, it is reported that after 13-week inhalation exposure (mist) of rats, exudate around the nose/mouth was observed in groups at or above 51 mg/m3, all the animals in a 215 mg/m3 group died or became moribund before the end of the test, and squamous cell metaplasia was found in the mucous membrane of the nasal cavity and trachea (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)). It was classified in Category 1 (respiratory tract) based on the above knowledge. On the other hand, in a 13-week diet administration test with rats, no treatment-related effects were seen in any groups, except for reduced weight gain found at or above 150 mg bw/kg/day, which is above the guidance values (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). Therefore, it corresponds to "Not classified" in the oral route. Also, the occurrence of hepatitis was reported in the above survey on 20 workers, but it was one case only (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), and effects on the kidney were seen in a 95-day oral administration test with guinea pigs, but it was mentioned that it was impossible to assess this because the test method was not according to the general test guidelines (Initial Risk Assessment Report 117 (NITE, CERI, NEDO, 2008)). There is also a description of blood effects, but blood tests lacked consistency, and there is a report denying the effects in an epidemiological survey (PATTY (5th, 2001), Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). Therefore, other effects were not used for classification.
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 0-72-hour ErC50 = 18.1 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (a 2-week degradation rate, by BOD: 55.5%, by TOC: 96.9%, by HPLC: 100% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and 21-day NOEC = 4.16 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), etc.). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being rapidly degradable (a 2-week degradation rate, by BOD: 55.5%, by TOC: 96.9%, by HPLC: 100% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and a low bioaccumulation estimate (log Kow = 0.35 (PHYSPROP Database, 2009)), despite 96-hour LC50 = 62 mg/L for fish (Leuciscus idus) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)). From the above results, it was classified as "Not classified."
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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