Item | Information |
---|---|
CAS RN | 26615-21-4 |
Chemical Name | 2-[(8-Chlordibenzo[b,f]thiepin-10-yl)oxy]-N,N-dimethylethanamine, (alias Zotepine) |
Substance ID | m-nite-26615-21-4_v1 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecules. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 degC) substances are not available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (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). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance contains oxygen and chlorine which are chemically bonded only to carbon or hydrogen. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. As relevant information, a LD50 value is 306 mg/kg for rats (RTECS (2007)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
4 | Skin sensitization | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
7 | Reproductive toxicity | Category 2, |
Warning |
H361 H362 |
P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501 |
In the package insert for the substance, it is reported that "This drug should not be given to pregnant women and women suspected of being pregnant. (In an animal test, increased neonatal mortality was reported.) " and "This drug should not be used during breast feeding. If mothers need to take this drug, they must be instructed not to breast feed (This drug was repotted to pass into breast milk)" (LODOPIN tablet package insert). Therefore, the substance was classified into Category 2 "Effects on or via lactation". As relevant information, there are reports of "there was no fetal effect" in rat and rabbit developmental toxicity tests (unknown exposure route) (Teratogenic 12th (2007)) and "fetotoxicity (stunted fetus)", "Effects on newborn (live birth index)" in two rat developmental toxicity tests (oral) (RTECS (2007); Arzneimittel-Forschung. Drug Research. vol. 29, p. 1600 (1979)), but the detailed test results are not clear. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
Zotepine has a strong antagonistic activity against central serotonin receptors and also has an antagonistic effect against dopamine receptors. In the substance's package insert, there are the following reports; Major Side Effects: convulsive seizure; Minor Side Effects: parkinsonian syndrome, drowsiness, and abnormal electroencephalogram (Package Insert of Lodopin tablet). Based on the information, the substance was classified into Category 1 (nervous system). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, blood) |
Danger |
H372 | P260 P264 P270 P314 P501 |
In the substance's package insert, there are the following reports; Major Side Effects: neuroleptic malignant syndrome, abnormal ECG, paralytic ileus, convulsive seizure, agranulocytosis, and leukopenia (Package Insert of Lodopin tablet). Based on this information, the substance was classified into Category 1 (nervous system, blood system). As relevant information, a change in sleeping hour and righting reflex, changes in psychophysiological tests, excitability, and changes in motor activity were observed in two men exposed (route unspecified) for 124 days and 9 days, respectively (RTECS (2007)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | No data available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
12 | Hazardous to the ozone layer | - |
- |
- | - | - | - | - |
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