GHS Classification Result

Chemical Name：Thiotepa
CAS：52-24-4

Result：
ID: 21A3737
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 Classification not possible - - - - Classification is not possible since no data are available though there are chemical groups (aziridine) present in the molecule associated with 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 classified - - - - The substance is considered to be stable against water since data are available that water solubility is 19 g/100 mL (25 degC) (Merck (14th, 2006)) though it contains metals.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance does not contain oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
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 46 mg/kg for mice (IARC vol. 9 (1975)), the substance was classified into Category 2. As relevant information, there are reports of LD50 values of 2.3 mg/kg for rats and 38 mg/kg for mice (RTECS (2009)).
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 - - - - Classification not possible due to lack of data. There is a report that contact can irritate and burn the eyes (HSFS (2001)).
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 positive results in a mouse dominant lethal test and a heritable translocation test (IARC vol. 50 (1990)), the substance was classified into Category 1B. As relevant information, positive results are also reported in other in vivo tests (mouse spermatogonium and spermatocyte chromosomal aberration tests, mouse bone marrow and embryo and rabbit peripheral lymphocytes chromosomal aberration tests, rat and mouse bone marrow micronucleus tests) (IARC vol. 50 (1990)). From in vitro mutagenicity tests, there are reports of positive Ames tests, chromosomal aberration tests and sister chromatid exchange tests (NTP DB (access on Oct, 2009), IARC vol. 50 (1990)).
6 Carcinogenicity Category 1A 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 1 by IARC (IARC vol. 50 (1990)) and classification of K by NTP (NTP ROC 11th, 2004)), the substance was classified as Category 1A. Several cases of leukaemia following treatment with this substance alone have been reported. One case-control study showed a strong association between risk for leukaemia and treatment with this substance. Additionally, in animal studies by intraperitonela administration, an increased incidence of lung tumours and lymphoproliferative malignancies was observed in mice of both sex, and an increased incidence of lymphoproliferative malignancies in male rats and of uterine adenocarcinomas and mammary carcinomas in female rats was observed (IARC vol. 50 (1990)).
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 ... 		In thiotepa package insert, it is reported that "Teratogenicity in animal tests", "This drug should not be given to pregnant women and women suspected of being pregnant" and "wide-range teratogenic effects such as oligodactyly and renal agenesis were observed in mouse (ip) and rat (sc) tests". The substance was classified into Category 1B.
8 Specific target organ toxicity - Single exposure Category 2 (systemic toxicity) Warning H371: May cause damage to organs (systemic toxicity) P309+P311: IF exposed or if you feel unwell: 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.
P405: Store locked up.
P501: Dispose of contents/container to ... 		The substance suppresses the bone marrow in humans (IARC vol. 50 (1990)). From information under the Adverse Reactions section of the package insert of Thiotepa, there are the following reports; leukopenia, thrombocytopenia, hemorrhage, anemia, renal failure, shock, hypogammaglobulinemia, hepatic disorder, anorexia, nausea, vomiting, diarrhea, stomatitis, diarrhea, dry mouth, abdominal pain, rash, malaise, headache, pharyngeal pain, increased bloody sputum, difficulty in urination, frequent urination, cystitis, fever, and alopecia. Since it is unclear whether these are acute effects, the substance was classified into Category 2 (systemic toxicity). As information in a document in List 3, there are the following reports: paresthesia, changes in bone marrow (not specified) in human treated parenterally (RTECS (2009): Cancer. Vol. 38, p. 1471, 1976); and flaccid paralysis (neuromuscular blockage), somnolence, ataxia at 38 mg/kg (LD50 value) in a mouse oral test (RTECS (2009): Imifos, Giller, S.A., ed., Izd, Riga, USSR, p. 129, 1968).
9 Specific target organ toxicity - Repeated exposure Category 1 (bone marrow, kidney, systemic toxicity) Danger H372: Cause damage to organs through prolonged or repeated exposure (bone marrow, kidney, systemic toxicity) 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 ... 		From information under the Adverse Reactions section of the package insert of Thiotepa, there are the following reports; significant adverse reactions: leukopenia, thrombocytopenia, hemorrhage, anemia, renal failure, and shock. Based on the data, the substance was classified into Category 1 (bone marrow, lung, systemic toxicity). In addition, there are the following reports; other adverse reactions: hypogammaglobulinemia, hepatic disorder, anorexia, nausea, vomiting, diarrhea, stomatitis, diarrhea, dry mouth, abdominal pain, rash, malaise, headache, pharyngeal pain, increased bloody sputum, difficulty in urination, frequent urination, cystitis, fever, and alopecia. No data with oral, dermal or inhalation routes are available for human or animals. The substance suppresses the bone marrow in humans and was used in the treatment of tumours (IARC vol. 50 (1990)). There is a report that the toxic effect is myelosuppression, characterized by granulocytopenia and thrombocytopenia; disturbances in hepatic and renal function, neurotoxicity, nausea and vomiting were uncommon (IARC vol. 50 (1990)).
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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