GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| 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 | H29-A-010 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | |
| Model SDS by MHLW (External link) | |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 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 |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not 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 chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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)). |
| 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. |
| 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. |
| 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. |
| 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). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
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. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |