GHS Classification Result
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
Reference：
Chemical Name：dapsone; 4,4'-diamino diphenyl sulfone
CAS：80-08-0
Result：
| ID: | 20A2010 |
| Classifier: | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| Year Classified: | FY2008 |
| Reference Manual: | GHS Classification Guidance by the Japanese Government （Sep, 2008） |
PHYSICAL HAZARDS
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable | - | - | - | - | There are no chemical groups associated with explosive properties present in the molecules. |
| 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 solid | Classification not possible | - | - | - | - | No data available. |
| 8 | Self-reactive substances and mixtures | Not applicable | - | - | - | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 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. (It may react strongly with zinc, tin, sodium, lithium, nickel, and palladium. There are no criteria established. It may also react strongly with oxidizing agents such as halogen, potassium permanganate, and chromium trioxide (HSDB (2006)).) |
| 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. |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 4 |
|
Warning | H302: Harmful if swallowed |
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P330: Rinse mouth. P501: Dispose of contents/container to ... |
Since the rat LD50 = 630mg/kg (males) and 650mg/kg (females) (IARC 24 (1980)), the substance was classified into Category 4. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | - | Although its classification would be "Not classified" based on the rabbit LD50 of > 4000mg/kg (RTECS (2007)), these were List 3 data and thus, classification is not possible. |
| 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 | Classification not possible | - | - | - | - | In vitro mutagenicity studies, such as Ames tests and chromosomal aberration tests using human lymphocytes, have yielded negative results (IARC 24 (1980)). However, there were no in vivo data available, and thus, classification is not possible. |
| 6 | Carcinogenicity | Not classified | - | - | - | - | The substance was classified into "Not classified" based on the IARC's Group 3 classification (IARC suppl. 7 (1987)). As relevant notes, in ingestion studies using rats, malignant tumors developed in the spleen of treated males (IARC 24 (1980)). |
| 7 | Reproductive toxicity | Classification not possible | - | - | - | - | No data available. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible | - | - | - | - | Although symptoms of Category 3 (narcotic effects) such as flaccid paralysis (i.p.) / lethargy and motor ataxia (oral route) were observed in rat studies (RTECS (2007)), the studies originate from the List 3 literature source and provide insufficient data. Thus, classification is not possible. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood) |
|
Danger | H372: Cause damage to organs through prolonged or repeated exposure (blood) |
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 ... |
The long-term prescription of Dapsone is often associated with mild hemolytic anemia accompanied with the formation of Methemoglobin (Fe3+ containing heme) (IARC 24 (1980)). Based on this report, the substance was classified into Category 1 (blood). |
| 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） |