GHS Classification Result

Chemical Name：colecalciferol; Vitamin D3
CAS：67-97-0

Result：
ID: 20A2074
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - No data available.
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 <= 140degC) 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 contains 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
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 2 Danger H300: Fatal if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Since its LD50 is 42 mg/kg, 42.5 mg/kg, and 43.6 mg/kg for rats (RTECS (2006)), and it is rated R24/25 in EU classification, the substance was classified into Category 2.
1 Acute toxicity （Dermal） Category 2 Danger H310: Fatal in contact with skin P302+P350: IF ON SKIN: Gently wash with plenty of soap and water.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P322: Specific treatment （see ... on this label）.
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Since its LD50 is 61 mg/kg (male), 185 mg/kg (female) for rats (PM (14th, 2006)), and it is rated R24/25 in EU classification (EU Annex I (accessed July 2008)), the substance was classified into Category 2.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Classification not possible - - - - Since no in vivo data are available, the substance cannot be classified. As relevant information, as for in vitro data, negative results from an Ames test have been obtained (NTP DB (accessed July 2008))
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		So far, it has been reported that excess vitamin D intake during pregnancy induces congenital abnormalities such as aortic valvular stenosis (Birth Defect (3rd, 2000), HSDB (2006)), but multiple reports have indicated that there is no relationship between excess maternal vitamin D intake and aortic valvular stenosis (Birth Defect (3rd, 2000)). As for effects on human fetuses, views are conflicting. In animal experiments, excess administration of colecalciferol has been reported to induce skeletal abnormalities in rats, cardiac abnormalities in rabbits, and microcephaly and skeletal abnormalities in mice (Birth Defect (3rd, 2000)). Especially in cases of rabbits, also similar findings to those of aortic valvular stenosis found in human cases have been obtained (HSDB (2006)). As described above, although its reproductive toxicities have been reported, views are conflicting, thus there is lack of information on the substance. Furthermore, as for animal experiments, these reports provide descriptions on inductions of such symptoms as cardiac abnormalities (rabbits, findings similar to those of aortic valvular stenosis), and microcephaly and skeletal abnormalities (mice), but no descriptions on general toxicity in parental animals. Thus, by placing emphasis on teratogenicity, the substance was classified into Category 1B.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Insufficient data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - There is no available animal experiment data. As for humans, it is documented that doses of vitamin D analogs which do not exceed the physiologic requirement are usually nontoxic (HSDB (2006)), or excess administration may lead to hypervitaminosis D manifested by hypercalcemia (HSDB (2006)). However, since detailed information on exposure conditions are not provided, classification is not possible. As relevant information, it is described that excess vitamin D intake causes firstly hypercalcemia, then calcinosis in bones, great vessel, the kidney, and the brain, and finally kidney disorders and digestion difficulties (the Medical Dictionary, 1978, Ishiyaku Publishers, Inc.). In experimental animals, excess vitamin D intake causes degeneration of tunica media, calcification of coronary arteries, and proliferation of smooth muscle cells (Casarett & Doull's Toxicology, 6th ed. (Japanese ed.), 2004, Scientist Press Co., Ltd.).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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