GHS Classification Result

Chemical Name：2-[(8-Chlordibenzo[b,f]thiepin-10-yl)oxy]-N,N-dimethylethanamine, (alias Zotepine)
CAS：26615-21-4

Result：
ID: 21A3759
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 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 solids 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 - - - - 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 Not applicable - - - - The substance contains oxygen and chlorine which are chemically bonded only to carbon or hydrogen.
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 - - - - Classification not possible due to lack of data. As relevant information, a LD50 value is 306 mg/kg for rats (RTECS (2007)).
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 Classification not possible - - - - No data available.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2, Additional category: Effects on or via lactation Warning H361: Suspected of damaging fertility or the unborn child
H362: May cause harm to breast-fed children 		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 ...
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P263: Avoid contact during pregnancy/while nursing.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product. 		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.
8 Specific target organ toxicity - Single exposure Category 1 (nervous system) Danger H370: Causes damage to organs (nervous 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 ... 		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).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, blood) Danger H372: Cause damage to organs through prolonged or repeated exposure (nervous system, 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 ... 		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)).
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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