NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	540-73-8
Chemical Name	1,2-Dimethylhydrazine
Substance ID	R01-A-006
Classification year (FY)	FY2019
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)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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	*	- -	-	-	There is a chemical group associated with explosive properties, neighboring nitrogen atoms, present in the molecule, but the classification is not possible due to no data.
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of -17 deg C (closed cup) and a boiling point of 81 deg C (both, Hommel (1991)).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There is a chemical group associated with explosive properties, neighboring nitrogen atoms, present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	*	- -	-	-	Because it is classified in Division 6.1, Subsidiary Risk 3, PG I in UNRTDG (UN2382), and it is considered to be not applicable to a pyrophoric substance, hazards of the highest precedence, it was classified as "Not classified."
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available.
17	Desensitized explosives	*	- -	-	-	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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. Besides, though it would be classified in Category 2 based on data on mice in (2) and (3), data on rats were given precedence according to the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) LD50 for rats: 100 mg/kg (PATTY (6th, 2012), HSDB (Access on June 2019)) [Reference Data, etc.] (2) LD50 for mice: male: 26 mg/kg, female: 60 mg/kg (ATSDR (1997)) (3) LD50 for mice: 36 mg/kg (PATTY (6th, 2012))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. Besides, though it would be classified in Category 2 based on data on guinea pigs in (2), data on rabbits were given precedence in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) LD50 for rabbits: 467 mg/kg (ATSDR (1997)) [Reference Data, etc.] (2) LD50 for guinea pigs: 131 mg/kg (ATSDR (1997))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. Besides, since the LC50 value was lower than the 90% of the saturated vapor concentration (91,981 ppm), the reference value in units of ppm was applied as a vapour without a mist. [Evidence Data] (1) LC50 for rats (4 hours): 280-400 ppm (ATSDR (1997)) (2) LC50 for rats (4 hours): 280 ppm (HSDB (Access on June 2019))
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] 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	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) This substance is strongly alkaline, so it is considered to be corrosive and irritating to the skin, eyes, and mucous membranes (PATTY (6th, 2012)). [Reference Data, etc.] (2) There is a description that contact with this substance may cause irritation to the skin, eyes, and mucous membranes (HSDB (Access on June 2019)). (3) Dermal discoloration and irritation were observed in dogs, rabbits and guinea pigs on dermal exposure to this substance (ATSDR (1997)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) This substance is classified in Category 1 in skin corrosion/irritation. (2) This substance is strongly alkaline, so it is considered to be corrosive and irritating to the skin, eyes, and mucous membranes (PATTY (6th, 2012)). [Reference Data, etc.] (3) There is a report that conjunctivitis and erythema in the eyelids occurred when 3 microL of this substance was administered to the eyes of rabbits (ATSDR (1997)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) As for in vivo, the results were positive in a micronucleus test, a chromosomal aberration test, a DNA damage test, a DNA adduct formation test, a sister chromatid exchange test, and an unscheduled DNA synthesis test with mice and rats (ATSDR (1997), IARC 71 (1999)). (2) As for in vitro, the result was positive in a mutation test with cultured human cells. There are negative and positive results in mouse lymphoma assays and bacterial reverse mutation tests (same as above).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on the classification results by other organizations in (1), it was classified in Category 1B in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2A by IARC because of evidence for genotoxicity as the mechanism of carcinogenic action, in addition to sufficient evidence of carcinogenicity in experimental animals (IARC 71 (1999)). It was also classified in Carc.1B by the EU (ECHA C&L Inventory (Access on June 2019)). [Reference Data, etc.] (2) As for experimental animals, many carcinogenicity tests with rats and mice, mainly by subcutaneous, infrequently by oral and other routes (intraperitoneal, etc.) were conducted. Whatever the route of administration, this substance produced a high incidence of adenomas and adenocarcinomas of the colon and to a lesser extent of adenomas and adenocarcinomas of the small bowel. In tests given with drinking water or by gavage, vascular tumours were observed in a high incidence (IARC 71 (1999)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a developmental toxicity test with female hamsters dosed by the oral route on day 12 of gestation, no developmental toxicity or teratogenicity was observed (ATSDR (1997)). This test was a limited test in which administration was of only one dosage for one day during the gestational period. (2) In a developmental toxicity test with female rats dosed intraperitoneally on days 6-15 of gestation, decreased body weight gain of maternal animals, decreased body weight of fetuses and slightly increased malformations were observed (IARC 71 (1999), PATTY (6th, 2012)). Since this test was conducted by intraperitoneal dose, it was not adopted as evidence of the classification.
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), since it was considered to show respiratory tract irritation in inhalation exposure, it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) This substance is strongly alkaline, so it is considered highly corrosive and irritating to the skin, eyes, and mucous membranes (PATTY (6th, 2012)). [Reference Data, etc.] (2) There is a report that, when male dogs were dosed by the oral route at 60 mg/kg/day once per week for 2 weeks, for a total of 2 times, 2/2 animals died and hepatic degeneration and hemorrhagic necrosis were observed (ATSDR (1997)). (3) Though there is no information on the route and dosage of the exposure and the details are unknown, there is a description that convulsions are caused by overexposure to this substance (PATTY (6th, 2012)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, heart, kidney)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (liver, heart, kidney). [Evidence Data] (1) In a test in which mice were dosed by feeding for 5 months, mild hepatitis was observed at 0.75 mg/kg/day (within the range for Category 1), focal myocytolysis, fibrosis, calcification of the heart, hepatitis, hepatocellular necrosis, hepatocellular hypertrophy, interstitial nephritis and pyelonephritis were observed at 1.6 mg/kg/day (within the range for Category 1) were observed (ATSDR (1997)). (2) Other than (1), in a test in which mice were dosed by feeding for 6 weeks, in a test in which dogs were dosed by gavage for 4 to 10 weeks (once per week) and in a test in which guinea pigs were dosed by gavage for 7 to 10 weeks (once per week), the effects on the liver were reported at all of the doses which correspond to Category 1 when converted to the guidance value (ATSDR (1997)).
10	Aspiration hazard	*	- -	-	-	[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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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.

To GHS Information