GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 53-16-7 |
| Chemical Name | 1,3,5(10)-Estratrien-3-ol-17-one [Estrone] |
| Substance ID | H29-A-013 |
| 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 |
- |
- | - | 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 is an organic compound containing oxygen (but not fluorine or chlorine) 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. |
| 6 | Carcinogenicity | Category 1A |
 Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
This substance (synonyms: estrone) is one of the estrogens and is used for the treatment of post-menopausal women, etc. (Ethical Pharmaceuticals 2017 (2016), HSDB (Access on August 2017)). In humans, although it is not confined to this substance alone, there is a report that the risk of women developing breast cancer rose significantly when conjugated estrogens (combination drug of sodium estrone sulfate, sodium equilin sulfate, and sodium 17 alpha-dihydroequilin sulfate) were administered to hysterectomized patients, or when conjugated estrogen and progestagen were used in combination (Ethical Pharmaceuticals 2017 (2016)). It is reported in multiple cohort studies and case studies that the risk of breast cancer and endometrial cancer increased in post-menopausal estrogen therapy with female hormone preparations, and IARC classified post-menopausal estrogen therapy in Group 1 (IARC 72 (1999)). In experimental animals, in any of the tests in which the substance was administered to castrated male mice in drinking water or feeding, to untreated male mice by dermal or subcutaneous/intramuscular dosing, and to castrated male rats or ovariectomized female rats by subcutaneous/intramuscular dosing, higher incidences of the mammary tumors were observed (IARC 21 (1979), IARC 72 (1999)). Moreover, in a subcutaneous administration test with untreated male and female rats, in addition to mammary tumors, pituitary tumors were observed in all cases, and malignant tumors in the kidney and pituitary adenomas were observed in a subcutaneous/intramuscular administration test with castrated male hamsters (IARC 21 (1979), IARC 72 (1999)). IARC concluded that there is sufficient evidence in experimental animals for carcinogenicity of estradiol and this substance (IARC 72 (1999)). From the above, it was classified in Category 1A for this hazard class. |
| 7 | Reproductive toxicity | Category 1A |
Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
This substance (synonyms: estrone) is one of the estrogens and is used for the treatment of post-menopausal women, etc. (Ethical Pharmaceuticals 2017 (2016), HSDB (Access on August 2017)). In humans, although it is not confined to this substance alone, conjugated estrogens (combination drugs of sodium estrone sulfate, sodium equilin sulfate, and sodium 17 alpha-dihydroequilin sulfate) are contraindicated for pregnant women or women who have possibility of pregnancy (pregnant woman, parturient woman, nursing women) because safety has not been established (Ethical Pharmaceuticals 2017 (2016)). In experimental animals, there are reports as follows: as a result of subcutaneous administration to pregnant rats at 0.02 mg/animal at the early phase of gestation (before the implantation of fertilized egg) or 0.0175 mg/kg/day on gestational days 1-7, the pregnancy was terminated; as a result of subcutaneous administration of 0.02-0.05 mg/kg/day to pregnant rats on gestational days 2-4, a dose-dependent decrease of a conception rate was observed; as a result of single subcutaneous administration of 0.4 mg/kg to pregnant rats on any of gestational days 8-11, marked reduction in the number of surviving fetuses and delayed delivery were observed; as a result of single subcutaneous administration of 0.14 mg/kg to pregnant rats on any of gestation days 6-10, a decreased number of the implantation, an increased number of dead fetuses and fetal growth abnormalities were observed (IARC 21 (1979)). Other than these, there is a report that an increased incidence of cleft palate (12.4% vs 1.1% (control group)) was observed in a test in which pregnant mice were injected subcutaneously at 0.1-0.2 mg/mouse on gestational days 11-16 (IARC 21 (1979)). From the above, since in humans, combination drugs containing this substance have been contraindicated for pregnant women, etc., and in experimental animals, it causes serious reproductive and developmental effects such as pregnancy failure, a decreased conception rate, fetal toxicity, and malformations, it was classified in Category 1A for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood coagulation system, nervous system, gallbladder) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
This substance (synonyms: estrone) is one of the estrogens and is used for the treatment of post-menopausal women, etc. (Ethical Pharmaceuticals 2017 (2016), HSDB (Access on August 2017)). In humans, although it is not confined to this substance alone, there is a description that thrombosis or thromboembolism (limbs, lung, heart, brain, retina, etc.) may appear as serious side effects of conjugated estrogen (combination drug of sodium estrone sulfate, sodium equilin sulfate, and sodium 17 alpha-dihydroequilin sulfate) (Ethical Pharmaceuticals 2017 (2016)). In addition, there is a report on the association of hormone replacement therapy (HRT) with a risk of coronary heart disease, stroke, dementia, and gallbladder disease, and it is reported that as for the HRT with a combination drug of conjugated estrogen and progestagen, the risk of the coronary heart disease, stroke, dementia including Alzheimer's, and the gallbladder disease increased significantly, and in the concurrently performed administration of conjugated estrogens to hysterectomized women, the risk of stroke (mainly cerebral infarction) and gallbladder disease was significantly higher, and an increased tendency in the risk of dementia including Alzheimer's was observed (Ethical Pharmaceuticals 2017 (2016)). From the above, since in humans, effects on the nervous system and gallbladder, in addition to thrombosis or thromboembolism, were observed, it was classified in Category 1 (blood coagulation system, nervous system, gallbladder). |
| 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) | Category 2 |
- |
H401 |
P273
P501 |
From 96-hour LC50 >10 mg/L for crustacea (Neomysis integer) (NLM HSDB:2012, EPA AQUIRE:2017, Ghekiere,A.et al (2006)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
 Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BioWin), and 40-day NOEC (survival rate) = 0.0000977 mg/L for fish (Danio rerio) (EPA AQUIRE: 2017, Holbech, H. et al. (2006)). Because acute toxicity data were not obtained for a trophic level (algae) for which chronic toxicity data were not obtained, it is classified as "Classification not possible." From the above results, it was classified in Category 1. |
| 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. |