GHS Classification Result

Chemical Name:Teniposide
CAS:29767-20-2

Result:
ID: 21A3743
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 - - - - 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 Not applicable - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is 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 - - - - No data available.
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 Category 2 Warning H341: Suspected of causing 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 intraperitoneal mouse chromosomal aberration tests using bone marrow and fetal tissue and intraperitoneal mouse bone marrow micronucleus test (in vivo somatic cell mutagenicity tests) (IARC 76 (2000)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of negative and positive Ames tests, a positive mouse lymphoma chromosomal aberration test, a positive CHO cell chromosomal aberration test and a positive CHO cell micronucleus test (IARC 76 (2000)).
6 Carcinogenicity Category 1B 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 ...
Since there are limited positive results for myeloid leukaemia in human epidemiologic tests and the substance is classified into "Group 2A" in IARC (IARC 76 (2000)), the substance was classified into Category 1B.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 ...
It has been reported that injection on day 7 or 8 of gestation caused embryolethality and increased the frequency of fetal malformations when pregnant mice were administered intraperitoneally on day 6, 7 or 8 of gestation (IARC 76 (2000)). Because there was no description for maternal general toxicity and the study was conducted using intraperitoneal routes, the substance was classified as Category 2.
8 Specific target organ toxicity - Single exposure Category 2 (bone marrow) Warning H371: May cause damage to organs (bone marrow) 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 ...
Based on the following information for human effects in a document of List 2; the major and dose-limiting adverse effect is hematologic toxicity (HSDB (2005)); and clinical effects of overdose: bone marrow suppression (HSDB (2005)), the substance was classified into Category 2 (bone marrow).
9 Specific target organ toxicity - Repeated exposure Category 1 (bone marrow, digestive system) Danger H372: Cause damage to organs through prolonged or repeated exposure (bone marrow, digestive system) 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 a phase I trial where three patients were treated over three days (300 - 1000 mg/m2), dose-limiting toxic effects with decreased leukocyte counts were observed in all patients at 1000 mg/m2 (IARC 76 (2000)). In a second phase I trial where the intravenous formulation was administered orally to several patients, the dose-limiting toxic effect was myelosuppression, and gastrointestinal toxicity was also common (IARC 76 (2000)). Based on these reports, the substance was classified into Category 1 (bone marrow, alimentary system). As relevant information, there are reports of adverse gastrointestinal effects in pediatric patients (HSDB (2005) and neurotoxicity (CNS depression) (HSDB (2005)) as drug information.
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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