Chemical Name:2,2-Dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]acetamide; Chloramphenicol
CAS:56-75-7
ID: | 527 |
Classifier: | Inter-ministerial Committee on GHS |
Year Classified: | FY2006 |
Reference Manual: | GHS Classification Manual (10 Feb, 2006) |
Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
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1 | Explosives | Classification not possible | - | - | - | - | Classification not possible due to lack of data on the kick-off temperature and decomposition energy (though the substance contains nitro groups with its oxygen budget calculated at -114). |
2 | Flammable gases (including chemically unstable gases) | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
3 | Aerosols | Not applicable | - | - | - | - | Not aerosol products |
4 | Oxidizing gases | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
5 | Gases under pressure | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
6 | Flammable liquids | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
7 | Flammable solids | Classification not possible | - | - | - | - | No data available |
8 | Self-reactive substances and mixtures | Classification not possible | - | - | - | - | Classification not possible due to lack of data, though containing nitro groups with explosive properties. |
9 | Pyrophoric liquids | Not applicable | - | - | - | - | Classified as "solid" according to 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 | - | - | - | - | Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) |
13 | Oxidizing liquids | Not applicable | - | - | - | - | Classified as "solid" according to GHS definition |
14 | Oxidizing solids | Classification not possible | - | - | - | - | Classification not possible due to lack of data, though being organic compounds containing oxygen bound to the elements other than carbon and hydrogen |
15 | Organic peroxides | Not applicable | - | - | - | - | Organic compounds containing no "-O-O-" structure |
16 | Corrosive to metals | Classification not possible | - | - | - | - | Test methods applicable to solid substances are not available |
Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
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1 | Acute toxicity (Oral) | Category 5 | - | Warning | H303: May be harmful if swallowed | P312: Call a POISON CENTER or doctor/physician if you feel unwell. | Based on the rat LD50 (oral route) value of 2,500mg/kg (RTECS (2006)). |
1 | Acute toxicity (Dermal) | Classification not possible | - | - | - | - | No data available |
1 | Acute toxicity (Inhalation: Gases) | Not applicable | - | - | - | - | Due to the fact that the substance is "solid" according to the GHS definition and inhalation of its gas is not expected. |
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 | - | - | - | - | Insufficient 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 negative data on multi-generation mutagenicity tests (dominant lethal tests), positive data on germ cell mutagenicity tests in vivo (chromosome aberration tests) and somatic cell mutagenicity tests in vivo (chromosome aberration tests), and the absence of data on germ cell genotoxicity tests in vivo, described in IARC 50 (1990) and IARC 10 (1976). | |
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 ... |
Due to the fact that the substance is classified as Category R by NTP (2005) and Group 2A by IARC (1990). | |
7 | Reproductive toxicity | Category 2 | Warning | H361: Suspected of damaging 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 the evidence of pup malformation including hydrocephalus and cleft palate observed in rat teratogenicity studies, described in IARC 10 (1976) (though no data are available regarding parental toxicity). | |
8 | Specific target organ toxicity - Single exposure | Classification not possible | - | - | - | - | No data available |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (bone marrow, nervous system, digestive system), Category 2 (heart) |
Danger Warning |
H372: Cause damage to organs through prolonged or repeated exposure (bone marrow, nervous system, digestive system) H373: May cause damage to organs through prolonged or repeated exposure (heart) |
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 the human evidence: "a case report of a 5-yr-old child who developed aplastic anemia and died of acute myeloblastic leukemia 1 year after chloramphenicol was therapeutically administered," "a case of a 63-yr-old man who developed bone marrow suppression 4 months after chloramphenicol was administered at a dose of 12g" (IARC 10 (1976)), "other adverse effects of prolonged administration included skin eruption, gastrointestinal disorder and nervous system damage" (IARC 50 (1990)), "there is symmetrical loss of ganglion cells from retina and atrophy of fibers in optic nerve," "cardiovascular collapse with cardiomyopathic changes and impaired left ventricular function was documented by echocardiography" (HSDB (2005)). Since the priority rating of the referenced study reporting the effects on the heart in humans is 2, these effects are classified into Category 2. | |
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) | Not classified | - | - | - | - | It was classified into Not classified from 48 hours EC50=345000microg/L of the crustacea (Daphnia magna) (AQUIRE, 2003). |
11 | Hazardous to the aquatic environment (Long-term) | Not classified | - | - | - | - | Since it was not water-insolubility (the water-solubility =2500mg/L (PHYSPROP Database, 2005)), and acute toxicity was low, it was classified into Not classified. |
* 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 Manual |
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Definitions / Abbreviations |
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Model Label by MHLW |
MHLW Website (in Japanese Only) |
Model SDS by MHLW |
MHLW Website (in Japanese Only) |