GHS Classification Result

Chemical Name:1-(2-Chloroethyl)-1-nitroso-3-[(2R,3R,4S,5R)-3,4,5,6-tetrahydroxy-1-oxohexan-2-yl]urea, (alias Chlorozotocin)
CAS:54749-90-5

Result:
ID: 21A3740
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 there are chemical groups (nitroso group and adjacent nitrogen) associated with explosive properties present in the molecules. Oxygen balance is -30.60.
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 (nitroso group and adjacent nitrogen) 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 - - - - No data 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) Classification not possible - - - - No data available.
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 2 Warning H341: Suspected of causing 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 positive results in a rat bone marrow DNA damage test by intraperitoneal injection (in vivo somatic cell genotoxicity test) (IARC vol. 50 (1990)) as well as Ames tests and Chinese hamster V79 cell HPRT gene mutation tests (in vitro mutagenicity tests) (IARC vol. 50 (1990)), the substance was classified into Category 2.
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 (IARC 50 (1990)), the substance was classified into Category 1B. It was reported that significantly increased incidence of sarcomas and mesotheliomas of the peritoneal cavity was observed in a carcinogenicity test where male and female rats were given intraperitoneal injections once a week for up to 800 days (IARC 50 (1990)).
7 Reproductive toxicity Classification not possible - - - - No data available. As relevant information, there is a report that all nitrosoureas have a possibility of teratogenicity, fetal toxicity and mutagenicity for animals (IARC vol. 50 (1990)).
8 Specific target organ toxicity - Single exposure Category 1 (hematopoietic system) Danger H370: Causes damage to organs (hematopoietic system) 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 ...
The substance was used for the treatment of cancers. Thrombocytopenia, leukopenia, elevated aminotransferase activity, nausea and vomiting were seen in patients after intravenous administration (IARC 50 (1990). Thrombocytopenia was the acute dose limiting toxicity in a phase I trial completed for a weekly times four dose schedule repeated every 8 weeks (HSDB (2009)). Additionally, it was reported that intraperitoneal injections to mice decreased peripheral white blood cell counts and spleen weights (IARC 50 (1990)). Based on all information, the substance was classified into Category 1 (hematopoietic system).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - No data available.
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)


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