NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	52-24-4
Chemical Name	Thiotepa
Substance ID	m-nite-52-24-4_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

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)

PHYSICAL HAZARDS

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	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.	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	- -	-	-	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.	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 does not contain oxygen, fluorine or chlorine.	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	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

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)	Category 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	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)).	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	- -	-	-	Classification not possible due to lack of data. There is a report that contact can irritate and burn the eyes (HSFS (2001)).	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	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 2 (systemic)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (bone marrow, kidney, systemic)	Danger	H372	P260 P264 P270 P314 P501	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)).	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）

ENVIRONMENTAL HAZARDS

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	-	- -	-	-	-	-	-

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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