NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	684-93-5
Chemical Name	N-Methyl-N-nitrosourea
Substance ID	m-nite-684-93-5_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Classification not possible	- -	-	-	It contains chemical groups (N-nitroso group) associated with explosive properties. Since no test results are available, classification is not possible.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It contains chemical groups (N-nitroso group) associated with explosive properties. Since no test results are available, classification is not possible.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
14	Oxidizing solids	Classification not possible	- -	-	-	It is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to nitrogen. Since no test results based on standardized testing methods are available, classification is not possible.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Since its rat LD50 = 110 mg/kg (IARC 17, 1978), the substance was classified into Category 3.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Nitrosamide compounds are generally skin irritants, vesicants, or skin sensitizers (Patty, 5th, 2001). Although this report indicates that the substance is irritating, classification of the substance is not possible based only on this report.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Nitrosamide compounds are generally skin irritants, vesicants, or skin sensitizers (Patty, 5th, 2001). Although this report indicates that the substance is irritating, classification of the substance is not possible based only on this report.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	This substance is known to cause skin dermatitis, which appears to be sensitization dermatitis rather than primary irritation (HSDB, 2003). In addition, nitrosamide compounds are generally skin irritants, vesicants, or skin sensitizers (Patty, 5th, 2001). Based on these descriptions, the substance was classified into Category 1.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	Based on positive results obtained in mouse dominant lethal test and mouse bone marrow micronucleus test (IARC 17, 1978; Mutat Res, 352, 159-167, 1996), the substance was classified into Category 1B.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It is rated as "Group 2A" by IARC S7 (1987) and "R" by the U.S. NTP (2005). Based on these ratings, the substance was classified into Category 1B.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In rats that received single intraperitoneal administration of the substance on day 2 of gestation, abnormalities of the brain were noted in most surviving fetuses (IARC 17 (1978)). In rats administered the substance on day 11-13 of gestation, malformation of the limbs were seen in 100% of fetuses. In addition, increased incidences of micrognathia, hydrocephaly, and microcephaly were noted in rats administered on day 13-14, day 12, and day 12-16 of gestation, respectively. And retarded development was seen in progeny that was born from parental animals that were administered the substance during the organogenic period. According to Patty 5th (2001), non-oral administration of this substance at 20 mg/kg to rats was associated with clear cases of teratogenic effects. Furthermore, according to HSDB (2003), in a study in which mice received single intraperitoneal administration of this substance on day 2 of pregnancy, all fetuses died at doses that did not show toxic effects to parental animals—the toxic dose range for fetuses and their development was one order magnitude lower than the toxic dose range for adult animals. Based on these reports, the substance was classified into Category 1B as toxic effects on reproduction occur at doses that do not induce general toxic effects on parental animals.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In Chinese hamsters administered the substance, damage to the pancreas and diabetes were noted (IARC 17 (1978)). However, since details such as route of administration were not provided, classification is not possible.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	Insufficient data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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.
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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