Item | Information |
---|---|
CAS RN | 148-82-3 |
Chemical Name | Melphalan |
Substance ID | m-nite-148-82-3_v1 |
Download of Excel format | Excel file |
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) | To Workplace Safety Site (MHLW) |
Sample SDS by MHLW (External link) | To Workplace Safety Site (MHLW) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
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 | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or 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 |
- |
- | - | No data 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 (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). | 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 contains oxygen and chlorine. Oxygen is chemically bonded only to carbon or hydrogen. Chlorine is chemically bonded only to carbon. | 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 |
- |
- | - | Test methods applicable to solid substances are not available. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
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 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. | 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 | Category 2 |
Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
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. | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
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)). | 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 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)). | 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" 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)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
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)). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
8 | Specific target organ toxicity - Single exposure | Category 1 (bone marrow) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
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). | FY2009 | GHS Classification Guidance by the Japanese Government (March, 2009) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (bone marrow, liver, systemic) |
Danger |
H372 | P260 P264 P270 P314 P501 |
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). | 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) |
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 | - |
- |
- | - | - | - | - |
|