NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	62-75-9
Chemical Name	N,N-Dimethylnitrosamine
Substance ID	H26-B-050, -
Classification year (FY)	FY2014
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)	GHS Classification Guidance for the Japanese Government (FY2013 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 classified	- -	-	-	There is a chemical group associated with explosive properties (nitroso group) present in the molecule, but because oxygen balance of -216 is lower than the criteria of -200, it was classified as "Not classified."
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 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	It was classified in Category 4 based on a flash point of 61 deg C (unknown test methods) (ICSC (2001)). Although test methods are not described, data obtained with closed-cup test methods are generally adopted in ICSC.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitroso group) present in the molecule, but the classification is not possible due to no data.
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	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 2	Danger	H300	P301+P310 P361+P364 P264 P270 P321 P330 P405 P501	Based on reports of LD50 values of 27-41 mg/kg (ACGIH (7th, 2001)), 23 mg/kg (pregnant female), 40 mg/kg (ATSDR (1989)), 23-40 mg/kg (CEPA (2001), CICAD 38 (2002)), 26 mg/kg and 37 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)) for rats, it was classified in Category 2.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on a report of an LC50 value (4 hours) of 78 ppm (240 mg/m3) for rats (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), CICAD 38 (2002), ACGIH (7th, 2001), CEPA (2001)), it was classified in Category 1. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (3,554 ppm), the reference value in units of ppm was applied as a vapour without a mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on a description that this substance was irritating to the skin (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), HSDB (Access on July 2014)), it was classified in Category 2. The category was changed by deleting the information sources in List 3 and adding new ones.
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Based on a description that this substance was irritating to the eyes (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), HSDB (Access on July 2014)), it was classified in Category 2. Since sufficient information for sub-categorization could not be obtained, the category was changed.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	As for in vivo, it was all positive in a micronucleus test with mouse germ cells, micronucleus tests with bone marrow cells and hepatocytes of mice, a chromosomal aberration test and a micronucleus test with hamster embryonic fibroblasts, a sister chromatid exchange test with mice, a gene mutation test with mice, and unscheduled DNA synthesis tests, DNA cleavage tests and DNA methylation tests with mice and rats (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), ATSDR (1989), CICAD (2002)), and it was negative in dominant lethal tests with mice and rats (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). In addition, DNA alkylation was observed in human liver DNA (ATSDR (1989)). As for in vitro, it was all negative in bacterial reverse mutation tests, a gene mutation test and a chromosomal aberration test with cultured mammalian cells, and sister chromatid exchange tests with cultured human cells and cultured mammalian cells. From the above, it was classified in Category 1B.
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It was classified in Group 2A by IARC (IARC Evaluations (IARC, Access on September 2014)), in A3 by ACGIH (ACGIH (7th, 2001)), in B2 by EPA (IRIS (1991)), as R by NTP (NTP (2011)), in Carc. Cat. 2 by the EU (EU (Access on September 2014)). From these classifications, the classification by ACGIH corresponds to Category 2, and all other classifications to Category 1B. From the above, it was classified in Category 1B by giving priority to the classifications by IARC according to the GHS Classification Guidance for the Japanese Government.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a reproductive and developmental toxicity studies with mice by the oral route (drinking water), an increase in time-to-conception, an increased total number of stillborn fetuses and neonatal death within 2 days and an increase in the proportion of males in the sex ratio at weaning (twofold) were reported at a dose of 0.02 mg/kg/day. There was no information on maternal animals (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), CICAD 38 (2002), ATSDR (1989)). In a developmental toxicity test with pregnant rats by the oral route (feeding), fetal death and the liver lesions in the fetuses (accumulation of plasma cells, eosinophils, macrophages, neutrophils and lymphocytes around the portal and hepatic vein) were reported at 5 mg/kg/day (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), CICAD 38 (2002)). Besides, it is described in CICAD 38 (2002) that "although no teratogenic effects were reported in these studies, interpretation of results of investigations was difficult owing to insufficient information on experimental design and results, lack of a control group and lack of data on maternal toxicity." Therefore, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 1 (liver), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, there are multiple reports, and it was irritating to the respiratory tract and affected the liver. Sore throat, coughing, nausea, diarrhea, vomiting, headache, weakness, jaundice, ascitic fluid, liver dysfunction, enlarged liver, splenic enlargement and abdominal distention by inhalation exposure to this substance, and nausea, vomiting, acute liver disease, bleeding, low platelet counts, gastrospasm, gastrointestinal hemorrhage, liver failure and cerebral hemorrhage by the oral ingestion were reported (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), ACGIH (7th, 2001), ATSDR (1989), CEPA (2001), CICAD 38 (2002), PATTY (6th, 2012)). As for experimental animals, hepatotoxicity was the most important effect. By inhalation exposure, hemorrhagic necrosis in the liver was reported in rats and mice (ACGIH (7th, 2001), ATSDR (1989), CEPA (2001), CICAD 38 (2002)). By the oral route, hepatotoxicity was observed, and there are reports of centrilobular necrosis with hemorrhage and hemorrhagic ascites within 24 hours accompanied by ascites and jaundice at 20 and 8 mg/kg in rats, and severe liver necrosis at 20-40 mg/kg in mice and guinea pigs (ACGIH (7th, 2001), ATSDR (1989), CEPA (2001), PATTY (6th, 2012)). In addition, there was a report of necrosis of the seminiferous epithelium by short-term exposure although the route was unknown (CICAD 38 (2002), CEPA (2001)). The effects on the liver in experimental animals were observed within the guidance value range corresponding to Category 1. As for necrosis of the seminiferous epithelium, it was not used for classification since the details were unknown, From the above, it was classified in Category 1 (liver), Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	There is a description that multiple fatal cases occurred from excessive ingestion of this substance in humans, two died of acute poisoning, at least 1 case died after oral ingestion more than 4 separate times over a period of 2 years, all the cases developed liver failure, and some cases who developed cirrhosis were also observed (ACGIH (7th, 2001), CICAD 38 (2002), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)), the liver was considered to be the primary target organ in humans. Also, in experimental animals, centrilobular necrosis of the parenchymal hepatocytes was observed in rats, guinea-pigs, monkeys and cats administered by gavage at 1 mg/kg/day for 30 days. In addition, it is reported that in a 12-week feeding test with rats, extensive necrosis of the hepatocytes was observed at a dose of Category 1 (about 3.8 mg/kg/day) and in a long-term administration tests with rats (96-week feeding and lifetime administration in drinking water), nodular hyperplasia occurred in the liver at very low doses of less than 1 mg/kg/day (CICAD 38 (2002), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). From the above, it was classified in Category 1 (liver).
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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.

To GHS Information