GHS Classification Result

Chemical Name：Melphalan
CAS：148-82-3

Result：
ID: 21A3736
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 and chlorine. Oxygen is chemically bonded only to carbon or hydrogen. Chlorine is chemically bonded only to carbon.
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 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 LD50 values of 13.0 mg/kg (male) and 16.0 mg/kg (female) for rats (HSDB (2009)), the substance was classified into Category 2.
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 Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		Based on a report that application to rabbits produced "mild to moderate" skin irritation and histopathological examination confirmed mild irritant (HSDB (2009)), the substance was classified into Category 2.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available. As relevant information, there is a report of strong irritant to eyes and mucous membranes (HSDB (2009)).
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 mouse dominant lethal test and heritable translocation test (in vivo heritable germ cell mutagenicity tests), the substance was classified into Category 1B (HSDB (2009)). As relevant information, there are reports of positive mouse bone marrow micronucleus test, chromosomal aberration test and SCE test (intraperitoneal injections) (NTP DB (access on Sep. 2009)) as well as a positive rat bone marrow mutagenicity test (IARC vol. 9 (1975)).
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), suppl. 7 (1987)) and classification of "K" in NTP (NTP ROC 11th, 2004)), the substance was classified into Category 1A. It was reported that ovarian carcinoma, multiple myeloma and breast cancer patients treated with the substance developed myelocytic leukaemia or bronchogenic carcinoma (IARC suppl. 7 (1987), vol. 9 (1975)). Among animal tests, it was reported that skin papillomas was observed in a rat dermal test and lung tumours, lymphosarcomas, mammary fibroadenomas and peritoneal sarcoma were observed in mice and rat intraperitoneal injection tests (IARC vol. 9 (1975)).
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 ... 		Based on a report that various malformations were observed in fetuses from rats treated during early pregnancy (IARC vol. 9 (1975)) and a report of teratogenic for rabbits (not rats) (Birth Defects (3rd, 2000)), the substance was classified into Category 1B. The substance is classified into Pregnancy Category D (There is positive evidence of human fetal risk) in FDA, however, this classification is based on the theoretical view of its mutagenic and carcinogenic properties (not sufficiently considered) (HSDB (2009)).
8 Specific target organ toxicity - Single exposure Category 1 (bone marrow) Danger H370: Causes damage to organs (bone marrow) 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 ... 		Based on a report that the substance is an antitumor drug which has significant side effects, myelosuppression (erythropenia, leukopenia, anemia) (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (bone marrow).
9 Specific target organ toxicity - Repeated exposure Category 1 (bone marrow, liver, systemic toxicity) Danger H372: Cause damage to organs through prolonged or repeated exposure (bone marrow, liver, 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 ... 		There are reports of bone marrow depression that results in leukopenia and thrombocytopenia, nausea and vomiting as adverse effects in patients treated with the substance (oral or IV) (HSDB (2009)). There are the following reports of clinical findings in DHP (13th, 2002): leukopenia, granulocytopenia, thrombocytopenia, hypoplasia of the bone marrow, nausea, vomiting, anorexia, hypocalcemia, and reversible lung disorder. Additionally, there are the following reports of clinically significant adverse reactions: myelosuppression (pancytopenia, leukopenia, thrombocytopenia, anemia), shock, anaphylactic reaction, serious hepatic disorder, jaundice, interstitial pneumonia, pulmonary fibrosis, and hemolytic anemia. Based on all the data, the substance was classified into Category 1 (bone marrow, liver, systemic toxicity).
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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