GHS Classification Result
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
Reference：
Chemical Name：1,3-Bis(2-chloroethyl)-1-nitrosourea, (alias Carmustine)
CAS：154-93-8
Result：
| ID: | 21A3738 |
| 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 contains chemical groups (adjacent nitrogen and nitroso group) associated with explosive properties present in the molecules. Oxygen balance is -93.44. |
| 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 (adjacent nitrogen and nitroso group) 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 | - | - | - | - | Classification is not possible since no data are available though the substance is solid (melting point <= 55 degC). |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 2 |
|
Danger | H300: Fatal 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 30 mg/kg bw for rats (IARC vol. 26 (1981)), the substance was classified into Category 2. |
| 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 | - | - | - | - | Classification not possible due to lack of data. Although there is a report that the substance caused burns in case of accidental contact with the skin (JAPIC prescription drug data (2010)), the details are not clear. |
| 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 a positive result in a mouse bone marrow micronucleus test (in vivo mutagenicity test) (IARC vol. 26 (1981)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of a positive bacteria mutagenicity tests and a positive cell chromosomal aberration tests (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 (IARC suppl. 7 (1987)) and classification of "R" in NTP (NTP RoC 11th (2004)), the substance was classified into Category 1B. |
| 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 ... |
When treated male rats were mated with untreated female rats, the number of implantations and viable fetuses on day 20 of gestation were significantly decreased. When rats were treated on days 6 - 9 of pregnancy, eye and central nervous system defects occurred in fetuses (IARC vol. 26 (1981)). Since these abnormalities were observed at dose levels at which no maternal toxicity was manifested (RTECS (2009)), the substance was classified into Category 1B. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (bone marrow) |
|
Danger | H370: Causes damage to organs (bone marrow) |
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 ... |
Since the substance can cause myelosuppression (thrombocytopenia, leukopenia) in humans as a major side effect (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (bone marrow). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (bone marrow, respiratory system, kidney) |
|
Danger | H372: Cause damage to organs through prolonged or repeated exposure (bone marrow, respiratory system, kidney) |
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 ... |
Based on a report that the substance can cause myelosuppression, pulmonary infiltration, pulmonary fibrosis and adverse effects on the kidney in humans as major side effects (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (bone marrow, respiratory system, kidney). As relevant information, the effects on the liver such as increased blood ALP and bilirubin level were reported in low incidence. |
| 10 | Aspiration hazard | Classification not possible | - | - | - | - | No data available. |
| 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:
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* 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：
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Reference Manual |
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Definitions / Abbreviations |
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Model Label by MHLW |
MHLW Website （in Japanese Only） |
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Model SDS by MHLW |
MHLW Website （in Japanese Only） |