GHS Classification Result

Chemical Name：Etoposide
CAS：33419-42-0

Result：
ID: 21A3735
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 contains oxygen 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） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		LD50 values of 1949 (male) and 1784 (female) mg/kg bw for rats (RTECS (2009), KSRNAM Kiso to Rinsho. Clinical Report. vol. 19, 3473 (1985)) correspond to Category 4.
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 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 rat and mouse spermatid micronucleus tests as well as a mouse metaphase oocyte chromosomal aberration test and an aneuploidy test (intraperitoneal injection) (IARC vol. 76 (2000)), the substance was classified into Category 1B. As relevant information, from in vitro mutagenicity tests, the results in most Ames tests were negative and results in cell chromosomal aberration tests and micronucleus tests were positive (IARC vol. 76 (2000)).
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" in IARC (IARC vol. 100A (2008)), the substance was classified into Category 1A. Many reports of myeloid leukaemia after treatment of cancer patients with the substance as a cytostatic drug were published. However, in a knockout mouse model test, increased incidence of leukaemia was not observed (IARC vol. 76 (2000)).
7 Reproductive toxicity Category 1A, Additional category: Effects on or via lactation Danger H360: May damage 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. 		The substance is used as an anticancer agent. In a test of 20 young and two older (=<50 years) women with gestational trophoblastic disease treated orally with etoposide, transient ovarian failure lasting two to four months was observed in five of the young women, and the two older women both had permanent ovarian failure (IARC vol. 76 (2000)). It was reported that the substance was used to induce abortion in two cases of ectopic pregnancy (IARC vol. 76 (2000)). Since these data show clear evidences of reproductive and developmental toxicity without dosage data, the substance was classified into Category 1A. Based on a report in an etoposide package insert that "If mothers take this drug, they must be instructed not to breast feed. The excretion into breast milk was reported in animals (rats)", the substance was classified as "Effects on or via lactation".
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 ... 		From information under the Adverse Reactions section of the package insert of Etoposide, there are the following reports; myelosuppression (pancytopenia, leukopenia, neutropenia, thrombocytopenia and hemorrhage, anemia, etc.), anaphylactic reaction (cyanosis, dyspnea, chest discomfort, reduction in blood pressure), interstitial pneumonia with fever, cough, dyspnea, chest x-ray abnormality, eosinophilia and etc., kidney or liver dysfunction, nausea, vomiting, anorexia, stomatitis, diarrhea, abdominal pain, constipation, rash, alopecia, erythema, itching, pigmentation, headache, numbness, transient cortical blindness, tachycardia, abnormal ECG, cardiac arrhythmia, reduction in blood pressure, electrolyte abnormality, malaise, fever, facial flushing, edema, decreased serum total protein, and dysgeusia. Since it is unclear whether these are acute effects, the substance was classified into Category 2 (systemic toxicity). As relevant information, it was reported that after intravenous infusion of a single dose of etoposide phosphate to dogs, leukopenia and thrombocytopenia was observed (IARC vol. 76 (2000)).
9 Specific target organ toxicity - Repeated exposure Category 1 (bone marrow, lung, systemic toxicity) Danger H372: Cause damage to organs through prolonged or repeated exposure (bone marrow, lung, 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 Etoposide, there are the following reports; significant adverse reactions: myelosuppression (pancytopenia, leukopenia, neutropenia, thrombocytopenia and hemorrhage, anemia, etc.), anaphylactic reaction (cyanosis, dyspnea, chest discomfort, reduction in blood pressure), interstitial pneumonia (interstitial pneumonia with fever, cough, dyspnea, chest x-ray abnormality, eosinophilia, etc.). Based on the data, the substance was classified into Category 1 (bone marrow, lung, systemic toxicity). As relevant information, there are the following reports; other adverse reactions: kidney or liver dysfunction, nausea, vomiting, anorexia, stomatitis, diarrhea, abdominal pain, constipation, rash, alopecia, erythema, itching, pigmentation, headache, numbness, transient cortical blindness, tachycardia, abnormal ECG, cardiac arrhythmia, reduction in blood pressure, electrolyte abnormality, malaise, fever, facial flushing, edema, decreased serum total protein, and dysgeusia. As relevant information, myelosuppression, leukopenia and neutropenia were reported as toxic effects in humans following oral and intravenous administration of the substance (IARC vol. 76 (2000)).
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）

To GHS Information