GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 52232-67-4 |
| Chemical Name | Teriparatide |
| Substance ID | H28-A-021, C-065A |
| Classification year (FY) | FY2016 |
| 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) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| 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 |
- |
- | - | The substance is a polypeptide and does not contain chemical groups associated with explosive properties 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 |
- |
- | - |
As for in vivo, a micronucleus test in mice was negative (HSDB (Access on June 2016)). As for in vitro, a bacterial reverse mutation test, and a mouse lymphoma test and chromosomal aberration tests using mammalian cultured cells was negative (HSDB (Access on June 2016)). Based on the above, this substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government. |
| 6 | Carcinogenicity | Category 1A |
 Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
This drug is generally considered to pose a high risk of causing osteosarcoma in pediatric patients and young adults whose bones have not undergone epiphyseal closure. The drug is contraindicated in such patients (Drugs in Japan 2017 (2016)). As for experimental animals, in a 2-year study using rats given the drug by subcutaneous injections, a dose-dependent increase in the incidence of osteosarcomas, osteoblastomas or osteoma is reported (HSDB (Access on June 2016)). As described above, there are no classifications by other organizations, but this drug is contraindicated in children and young adults because of the risk of osteosarcoma. Therefore, this substance was classified in Category 1A. |
| 7 | Reproductive toxicity | Category 1A |
Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
As for humans, based on data on experimental animals, this drug is contraindicated in pregnant women, in women who may possibly be pregnant, and in lactating women (Ethical Pharmaceuticals 2017 (2016)). As for experimental animals, the following information is described: in a study using pregnant mice administered by subcutaneous injections from gestation day 6 through 15, skeletal deviations or variations were observed; in a study using pregnant rats administered by subcutaneous injections from gestation day 6 through postpartum day 20, growth retardation in female offspring and reduced motor activity in both male and female offspring were observed; and in a study using pregnant rabbits administered by subcutaneous injections, fetotoxicity (increase in embryonic death) was observed ((HSDB (Access on June 2016), Ethical Pharmaceuticals 2017 (2016)). From the above, in the subcutaneous administration which is a clinical route, teratogenicity and embryo-feto-toxicity were observed in the experimental animals, and the substance is contraindicated in pregnant women. Therefore, the substance was classified in Category 1A. Besides, "Additional category: Effects on or via lactation" was not added to the classification because there was no evidence corresponding to the specific conditions of the GHS classification. |
| 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 is administered by subcutaneous injection as a therapeutic agent for osteoporosis. It is reported that, following the administration of this substance in humans, transient elevations in serum calcium levels (peaking at about 4 to 6 hours after administration) are seen, and that nausea, vomiting, constipation, lethargy, muscle weakness, orthostatic hypotension, and dizziness may appear (Ethical Pharmaceuticals 2017 (2016)). Therefore, this substance was classified in Category 1 (central nervous system) and Category 3 (narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver, systemic toxicity) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
This substance is administered by subcutaneous injection as a therapeutic agent for osteoporosis. As for humans, as side-effect information, side effects (including laboratory abnormalities) were observed in 50 cases out of 252 cases (19.8%). It is reported that the main side effects were 9 cases of increase in blood uric acid (3.6%), 7 cases of headache (2.8%), 7 cases of nausea (2.8%), 5 cases of increase in alkaline phosphatase (2.0%), 3 cases of muscle spasms (1.2%), 3 cases of hyperuricemia (1.2%), 3 cases of anorexia (1.2%), and 3 cases of increase in blood urea (1.2%) (Ethical Pharmaceuticals 2017 (2016)). In addition, as an additional side effect, an increase in AST, ALT and gamma-GTP indicating hepatic function abnormality is reported (Ethical Pharmaceuticals 2017 (2016)). Therefore, this substance was classified in Category 1 (liver, systemic toxicity). |
| 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:
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* 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. |