NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	107-15-3
Chemical Name	Ethylenediamine
Substance ID	23B5524
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	- -	-	-	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	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It corresponds to Category 3 from a flash point of 34 deg C [closed-cup] (ICSC (2003)), which is >= 23 deg C and <= 60 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	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 390 deg C (Ullmanns (E) (6th, 2003)).
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. Besides, there is information "It is corrosive to iron and galvanized iron and very corrosive to aluminum, zinc, and ZIII (without inner protective lining). Stainless steel and tin-plated iron are resistant." (Hommel (1996)).

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 LD50 values for rats of 637, 1,850 mg/kg (the above, SIDS (2001)), 1,160 mg/kg (ACGIH (2001)), 1,200 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)) correspond to Category 4. Because this substance is highly alkaline, it is neutralized by hydrochloric acid contained in the stomach to become the dihydrochloride. Therefore, there is little difference in pharmacokinetics and toxicity observed between this substance and its dihydrochloride via the oral route (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)).
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	All four LD50 values for rabbits [550 mg/kg (Japanese Journal of Industrial Health Vol. 33 No. 4 (1991)), 560 mg/kg (SIDS (2001)), 730 microL/kg (converted value: 655 mg/kg) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), 657 mg/kg (ACGIH (2001))] correspond to Category 3.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Because there was no death after exposure of rats to 2,000 ppm/8 hours (converted value: 2,828 ppm/4 hours), and six out of six animals died at 4,000 ppm/8 hours (converted value: 5,656 ppm/4 hours) (ACGIH (2001)), both LD0 and LD100 correspond to Category 4. Therefore, it was classified in Category 4. Besides, the test was done below 90% of the saturated vapour pressure concentration (14300 ppm), the reference value of gasses was applied.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	It was classified as "Not classified" based on an LC50 value for rats of > 29 mg/L/8 hours (converted value: > 58 mg/L/4 hours) (SIDS (2001)). Besides, because the test was conducted above the saturated vapour pressure concentration (39 mg/L), the reference value for dust/mist was applied.
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	It is described that in a test in which undiluted this substance was applied to rabbits for 1 minute, there were severe inflammation and necrosis at the application site, and some animals had scars that reached the muscle (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)), and in a test by 24-hour occlusive application of the undiluted this substance to rats, necrosis that reached the deep skin occurred and was still seen after 14 days (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)). Therefore, it was classified in Category 1. Besides, pH was 11.8 (5 g/L aqueous solution) (SIDS (2001)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is reported that necrosis on the corneal surface occurred after 18-24 hours in a test in which 5 microL of the undiluted substance was applied to rabbits, and in a test in which 50 microL of the undiluted substance was applied, there were marked irritation of the eye mucosa and severe corneal opacity after 1 hour, which became purulent after a few days and remained for eight days. Furthermore, it is reported that in a test in which aqueous solutions of substance were applied to rabbits, those with concentrations of 10% or above were corrosive, accompanied by necrotic inflammation and corneal opacity (the above, Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)). Therefore, it was classified in Category 1. Besides, pH was 11.8 (5 g/L aqueous solution) (SIDS (2001)).
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	It was classified in Category 1 because the Japan Society For Occupational Health (JSOH) classified it in occupational sensitizers to the airway Group 2 (Recommendation of Occupational Exposure Limits Vol. 52 (Japan Society For Occupational Health (JSOH), 2010)). Besides, as for effects in humans, respiratory sensitization was observed in three out of 35 workers by occupational exposure to a mixture of ethylene amines, including ethylenediamine, up to four years, and it was concluded that ethylene amines were the main causal substances of respiratory sensitization (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)). In a test in which six workers with respiratory defect out of 48 workers who showed asthmatic symptoms after mixed exposure to low-molecular-weight chemical substances, including ethylenediamine, in the workplace were given inhalation exposure to ethylenediamine at a low concentration that is not irritating, and four of them had a positive reaction, immunoglobulin E antibodies to ethylenediamine were detected in all the 48 subjects, and it was concluded that ethylenediamine has a respiratory sensitizing potential (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)).
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It was classified in Category 1 because it is listed as a contact allergen in Contact Dermatitis (5th, 2011), and the Japan Society For Occupational Health (JSOH) classified it in occupational skin sensitizers Group 1 (Recommendation of Occupational Exposure Limits Vol. 52 (Japan Society For Occupational Health (JSOH), 2010)). Besides, it is reported that it was a strong sensitizer with a positive rate of 90% in a guinea pig maximization test (SIDS (2001)), and it was sensitizing with a positive rate of 50-100% 24 hours after the challenge in a Buehler test with guinea pigs (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)).
5	Germ cell mutagenicity	Not classified	- -	-	-	There are no data from an in-vivo germ cell mutagenicity test or an in-vivo somatic cell mutagenicity test, and it was a negative result in a dominant lethal test by oral administration to rats (in vivo heritable germ cell mutagenicity test) (SIDS (2001)). Therefore, it was classified as "Not classified." Besides, it is reported that it was negative (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)), or positive (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007), NTB DB Study ID 986505 (1980), NTB DB Study ID 942194 (1983), NTB DB Study ID 572096 (1984), NTB DB Study ID 414798 (1984)) in Ames tests, and negative in an HGPRT test with CHO cells (SIDS (2001)).
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was classified in A4 by ACGIH (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)) and Group D by EPA (IRIS (2003)). Besides, it is reported that no carcinogenicity was observed in a test in which 25 microL of a 1% aqueous solution of ethylenediamine was dermally applied to mice three times per week for a lifetime (SIDS (2001)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There are no data on this substance itself, but in a test by diet administration of ethylenediamine dihydrochloride, the related substance, to pregnant rats during the organogenesis period, resorptions increased, and decreased body weight, decreased crown-rump length, an increased incidence of shortened (or missing) innominate arteries, and an increased incidence of unossified sternum were observed in fetuses at the dose (1000 mg/kg/day) where maternal animals showed reduced weight gain and decreased food consumption (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)). Furthermore, these results were confirmed in an additional test by gavage administration of the same dose to rats during the organogenesis period (SIDS (2001)). Therefore, it was classified in Category 2. Besides, it is reported that in a two-generation test by diet administration to rats, no fertility impairment or toxicity in offspring was found at doses where parent animals showed toxicity (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)), and no embryotoxicity or teratogenicity was observed in a test by oral administration to pregnant rabbits during the organogenesis period (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As effects in humans, it is described that this substance is corrosive to the eye, skin, and respiratory tract, and inhalation of vapour or fumes may cause pulmonary edema (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). Therefore, it was classified in Category 1 (respiratory system). Besides, there is a description of a fatal case report of acute intoxication, in which a worker had dermal and inhalation exposure, developed tachycardia and tubulonephrosis accompanied by hyperkalemia and anuria due to hemolysis from 4 hours after exposure, and died of ischemic heart disease at 55 hours after exposure (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)), but it was not used for classification due to one case only and no other supporting data.
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney, visual organs)	Warning	H373	P260 P314 P501	In a 30-day inhalation toxicity test with rats, there is a description of alopecia, reduced weight gain, increased relative weight of the liver and kidney, and cloudy swelling of hepatocytes and renal tubules at or above 0.22 mg/L/6 hours (converted guidance value), of degeneration of convoluted renal tubules and congestion of the lung and adrenal gland at 0.47 mg/L/6 hours (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)). Because these are toxicity effects within the guidance value range for Category 2, it was classified in Category 2 (liver, kidney). Furthermore, it was classified in Category 2 (visual organs) because cataract and retinal atrophy were observed at 100 mg/kg (a converted value equivalent to ethylenediamine) in a test by 90-day oral administration of ethylenediamine dihydrochloride to rats (Initial Risk Assessment Report Ver.1.0, 55 (NITE, CERI, NEDO, 2007)).
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 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 3.0 mg/L for crustacea (Daphnia magna) (SIDS, 2004).
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	It was classified in Category 3 due to being rapidly degradable (a 4-week degradation rate: BOD (NO2): 39%, BOD (NH3): 94%, TOC: 96%, HPLC: 100% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and 21-day NOEC = 0.16 mg/L for crustacea (Daphnia magna) (SIDS, 2004, etc.).
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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