NITE - Chemical Management Field

GHS Classification Result

Chemical Name：1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea, (CCNU)
CAS：13010-47-4

Result：


ID:	21A3739
Classifier:	Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified:	FY2009
Reference Manual:	GHS Classification Guidance by the Japanese Government （March, 2009）

PHYSICAL HAZARDS

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
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.
2	Flammable gases （including chemically unstable gases）	Not applicable	-	-	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	-	-	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	-	-	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	-	-	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	-	-	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	-	-	-	-	No data available.
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.
9	Pyrophoric liquids	Not applicable	-	-	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	-	-	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	-	-	-	-	Test methods applicable to solid (melting point <= 140 degC) 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	-	-	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	-	-	-	-	No data available.
15	Organic peroxides	Not applicable	-	-	-	-	Organic compounds containing no bivalent -O-O- structure
16	Corrosive to metals	Classification not possible	-	-	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
1	Acute toxicity （Oral）	Category 3		Danger	H301: Toxic if swallowed	P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P321: Specific treatment （see ... on this label）. P330: Rinse mouth. P405: Store locked up. P501: Dispose of contents/container to ...	Based on a LD50 value of 71 - 73 mg/kg bw for rats (IARC vol. 26 (1981)), the substance was classified into Category 3.
1	Acute toxicity （Dermal）	Classification not possible	-	-	-	-	No data available.
1	Acute toxicity （Inhalation: Gases）	Not applicable	-	-	-	-	Solid (GHS definition)
1	Acute toxicity （Inhalation: Vapours）	Classification not possible	-	-	-	-	No data available.
1	Acute toxicity （Inhalation: Dusts and mists）	Classification not possible	-	-	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	-	-	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	-	-	-	-	No data available.
4	Respiratory sensitization	Classification not possible	-	-	-	-	No data available.
4	Skin sensitization	Classification not possible	-	-	-	-	No data available.
5	Germ cell mutagenicity	Category 1B		Danger	H340: May cause genetic defects	P308+P313: IF exposed or concerned: Get medical advice/attention. P201: Obtain special instructions before use. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P405: Store locked up. P501: Dispose of contents/container to ...	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)).
6	Carcinogenicity	Category 1B		Danger	H350: May cause cancer	P308+P313: IF exposed or concerned: Get medical advice/attention. P201: Obtain special instructions before use. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P405: Store locked up. P501: Dispose of contents/container to ...	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)).
7	Reproductive toxicity	Category 1B		Danger	H360: May damage fertility or the unborn child	P308+P313: IF exposed or concerned: Get medical advice/attention. P201: Obtain special instructions before use. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P405: Store locked up. P501: Dispose of contents/container to ...	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.
8	Specific target organ toxicity - Single exposure	Category 1 (liver, bone marrow), Category 2 (systemic toxicity)		Danger Warning	H370: Causes damage to organs (liver, bone marrow) H371: May cause damage to organs (systemic toxicity)	P307+P311: IF exposed: Call a POISON CENTER or doctor/physician. P260: Do not breathe dust/fume/gas/mist/vapours/spray. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P321: Specific treatment （see ... on this label）. P405: Store locked up. P501: Dispose of contents/container to ... P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.	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)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (bone marrow), Category 2 (lung, liver, kidney, nervous system)		Danger Warning	H372: Cause damage to organs through prolonged or repeated exposure (bone marrow) H373: May cause damage to organs through prolonged or repeated exposure (lung, liver, kidney, nervous system)	P260: Do not breathe dust/fume/gas/mist/vapours/spray. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P314: Get medical advice/attention if you feel unwell. P501: Dispose of contents/container to ...	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)).
10	Aspiration hazard	Classification not possible	-	-	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
11	Hazardous to the aquatic environment （Acute）	Classification not possible	-	-	-	-	No data available.
11	Hazardous to the aquatic environment （Long-term）	Classification not possible	-	-	-	-	No data available.

NOTE:

* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：

Reference Manual
Definitions / Abbreviations
Model Label by MHLW	MHLW Website （in Japanese Only）
Model SDS by MHLW	MHLW Website （in Japanese Only）