NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	13010-47-4
Chemical Name	1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea, (CCNU)
Substance ID	m-nite-13010-47-4_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	- -	-	-	Classification is not possible since no data are available though the substance is possible to be classified into "Explosives" from which it contains chemical groups (N-N or N-O) associated with explosive properties present in the molecules and oxygen balance is -164.31 which is >-200.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Classification is not possible since no data are available though there are chemical groups (N-N and N-O) associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 degC) substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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	Based on a LD50 value of 71 - 73 mg/kg bw for rats (IARC vol. 26 (1981)), the substance was classified into Category 3.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	Based on a positive result in a rat dominant lethal test (in vivo heritable germ cell mutagenicity test) (IARC suppl. 7 (1987)), the substance was classified into Category 1B. As relevant information, there are reports of positive rat and mouse DNA damage tests (in vivo somatic cell genotoxicity tests) (IARC suppl. 7 (1987)). From in vitro mutagenicity tests, there are reports of positive Chinese hamster cell sister chromatid exchange tests, Chinese hamster cell and Salmonella typhimurium gene mutation tests (IARC suppl. 7 (1987)) (IARC vol. 26 (1981)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on the classification of "Group 2A" in IARC, the substance was classified into Category 1B. Producing lung carcinomas was confirmed in a rat carcinogenicity test by intraperitoneal injection and there are several case reports showing the carcinogenic risk to humans (IARC vol. 26 (1981)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	Based on a report of "Loss of fertility, may cause fetal harm" as less common side effects (PDR 64 edition (2010)) and a report that teratogenic effects were observed in a rat intraperitoneal test and abortion was observed in a rabbit test (IARC vol. 26 (1981)), the substance was classified into Category 1B.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (liver, bone marrow), Category 2 (systemic)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	There is a report that hepatotoxic findings were observed in rats administered orally at dose levels of 20 - 100 mg/kg within the guidance value range for Category 1 (HSDB (2009)). In Physicians' Desk Reference (PDR 64 edition (2010)), there are reports of decreased white blood cell count, red blood cell count and platelet count; nausea and vomiting in the section on Major Side Effects. Based on the data, the substance was classified into Category 1 (liver, bone marrow). As relevant information, there are reports of anorexia, sore mouth, lassitude, diarrhea, alopecia, rash, confusion, difficulty in walking, and effects on the lung, liver and kidney in the section on Minor Side Effects. Since it is unclear whether these are acute effects, the substance was classified into Category 2 (systemic toxicity). As relevant information, there is a report that in a toxicological evaluation of a single i.v. infusion of 2.5 - 30 mg/kg in dogs and monkeys, both species exhibited toxic changes in bone marrow, lymphoid tissue, kidney and liver (IARC vol. 26 (1981)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (bone marrow), Category 2 (lung, liver, kidney, nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In Physicians' Desk Reference (PDR 64 edition (2010)), there are reports of: decreased white blood cell count, red blood cell count and platelet count; nausea and vomiting (acute symptoms) in the section on Major Side Effects. Based on the data, the substance was classified into Category 1 (bone marrow). In the section on Minor Side Effects, there are reports of anorexia, sore mouth, lassitude, diarrhea, alopecia, rash, confusion, difficulty in walking, and effects on the lung, liver and kidney. Since it is unclear whether these are secondary effects, the substance was classified into Category 2 (lung, liver, kidney, nervous system). In addition, there are reports that hepatic toxicity, alopecia, renal failure, renal damage, lethargy, ataxia, contact dermatitis, short-term hyperpigmentation, telangiectasia, cutaneous pain, and pruritus have occurred in patients receiving the therapy, and also that bone marrow depression, nausea and vomiting, stomatitis, alopecia has occurred (HSDB (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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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