Item | Information |
---|---|
CAS RN | 53-19-0 |
Chemical Name | 1,1-Dichloro-2-(2-chlorophenyl)-2-(4-chlorophenyl)ethane [o,p'-DDD, Mitotane] |
Substance ID | m-nite-53-19-0_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) | 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) |
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 molecule. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not available. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Vapours) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There was no in vivo data. As for in vitro, it was negative in all of the following: a bacterial reverse mutation test, a mammalian cell chromosome aberration test and a mammalian cell sister chromatid exchange test (NTP DB (Access on August 2017)). | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | Because there was no test data on this substance (o,p'-DDD: metabolite of o,p'-DDT (CAS RN 789-02-6)), it was not possible to classify due to lack of data. Besides, regarding p,p'-DDD (CAS RN 72-54-8, metabolite of p,p'-DDT (CAS RN 50-29-3)) which is the isomer of this substance, it was classified in B2 (Probable human carcinogen) by the EPA because there was sufficient evidence for carcinogenicity from the increased incidence of tumors (thyroid tumors in rats, lung and liver tumors in mice) observed in the experimental animals, and it was metabolite of p,p'-DDT (IRIS (1988)). Therefore, it corresponds to Category 1B. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no information on reproductive effects in humans. As for experimental animals, in a study in which pregnant female rats were dosed by gavage with this substance at 28 mg/kg/day on Gestational Day 15-19, delay in vaginal opening in the offspring was observed, but no other abnormality was observed (ATSDR (2002)). Therefore, there was only a minor developmental effect, and it was judged that it should not be adopted as evidence for classification. Other than this, there was no data on reproductive and developmental effects of this substance. Therefore, it was not possible to classify due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system), Category 3 (narcotic effects) |
Danger Warning |
H370 H336 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
This substance (synonym: mitotane) is a corticosteroid synthesis inhibitor, and it is a pharmaceutical used for the treatment of adrenal cancer and Cushing's syndrome. Although details of the number of doses are unknown, it is described that dizziness and lethargy as side effects may appear at a frequency of less than 1-10% (Ethical Pharmaceuticals 2017 (2016)). Therefore, this substance was classified in Category 1 (central nervous system), Category 3 (narcotic effects). Besides, there is a description in the pharmaceutical package insert (revised in July 2017) that central nervous system symptoms may appear due to overdose. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, liver, gastrointestinal tract, kidney, adrenal gland) |
Danger |
H372 | P260 P264 P270 P314 P501 |
This substance is a corticosteroid synthesis inhibitor, and it is a pharmaceutical used for treatment of adrenal cancer and Cushing's syndrome (Ethical Pharmaceuticals 2017 (2016)). In a survey of 482 cases, the side effects were 329 (68.26%) and the number of occurrence of adverse effects was 796, and as its main ones, anorexia (18.46%), nausea (10.58%), increased gamma-GT (10.58%), increased serum cholesterol (10.37%), increased AST (8.51%), increased ALT (7.88%), and liver function disorder (6.43%) were reported at high frequencies (Ethical Pharmaceuticals 2017 (2016)). In addition, it is described that a malfunction of the brain and adrenal gland insufficiency may occur at long-term high-doses, and there is a report that as serious side effects, adrenal gland insufficiency, stomach ulcers, gastrointestinal bleeding, erythroderma, dementia, delusions, hypoglycemia, kidney damage (renal tubular damage), liver function disorder, and jaundice may appear (Ethical Pharmaceuticals 2017 (2016)). Moreover, other than this, there is a report in HSDB (Access on August 2017) that blurred vision, double vision, lens opacities, toxic retinopathy, optic neuritis, papilledema, and retinal hemorrhages associated with toxic retinopathy were observed infrequently. These findings were from the information source listed as List 2, and were not adopted because they are rare side effects. From the above, by considering severity, frequency of occurrence, etc., it was classified in Category 1 (central nervous system, liver, gastrointestinal tract, kidney, adrenal gland). |
FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | No data available. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. | FY2017 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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