GHS Classification Result

Chemical Name：5-Fluorouracil
CAS：51-21-8

Result：
ID: 22A4093
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

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 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 fluorine and oxygen which are 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 3 Danger H301: Toxic 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 ... 		Based on the rat LD50 values of 230 mg/kg (HSDB (2007)), the substance was classified into Category 3.
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
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 were available. As relevant notes, there was a case report on a physician who accidentally instilled the solution containing 50 mg/mL into eyes. By thoroughly washing eyes after 3 - 5 min eyes, no significant reaction occurred except slight itching and transient hyperemia. Subsequent ophthalmologic examination showed no significant abnormality (HSDB (2007)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects 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 ... 		The classification was concluded as Category 2 based on the positive results in both micronucleus test using bone marrow of mice (IARC 26 (1981)) and the micronucleus test using fetal liver obtained from mice intraperitoneally administered on day-13 of gestation period (HSDB (2007)) (both, in vivo mutagenicity test in somatic cells). As relevant information, a slight increase in the number of numerical and structural aberrations of the chromosome was observed in peripheral blood lymphocytes in 3 of 4 patients with solid cancer who were administered only this substance (IARC 26 (1981)). As for in vitro studies, negative results in the Ames test (NTP DB (Access on Sep. 2010)), positive results in the chromosome aberration test using CHO cells (IARC 26 (1981)) and positive results in the chromosome aberration test using hamster fibroblast cells (HSDB (2007)) were reported.
6 Carcinogenicity Classification not possible - - - - The classification was concluded as "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment (IARC suppl.7 (1987)). As relevant information, no evidence of carcinogenicity was found in the examination after 6-month observation periods following 52-week oral administration with this substance (IARC suppl.7 (1987)).
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 ... 		This substance, known as an antimetabolite agent, was a potent teratogen in all six species tested, namely, mice, rats, guinea pig, hamsters, rabbits, and monkeys. It readily induced multiple malformations in mice, rats, and guinea pig. Cleft palate was produced in hamsters, and amelia induced in rabbits. In addition, rib and vertebral anomalies along with increased embryonic death in monkeys were the evidence of teratogenicity (Birth Defects, 3rd (2000)). Although in human, the influence of this substance is uncertain, an older woman with malignant tumors in intestine who was treated at 11 - 12 weeks of pregnancy with the substance revealed abortion at 16 weeks. The abortus revealed bilateral radial aplasia with the absence of thumbs, the absence of fingers of both hands and variety of organ malformation (Birth Defects, 3rd (2000)). As mentioned above, although the certain evidence was not provided in human, it was shown that this material had teratogenicity in some animal species, and it was estimated that the substance may adversely affect the development of the pups. Therefore, the substance was classified as Category 1B.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 1 (digestive system, bone marrow, nervous system) Danger H372: Cause damage to organs through prolonged or repeated exposure (digestive system, bone marrow, nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		This substance was an antimetabolite, and was used as an antineoplastic drug. By oral ingestion of the substance in tablets or dry syrup, as significant side effects were shown in alert insertions as follows (Handbook of Japanese drugs for therapeutics (2010)): serious enteritis such as marked diarrhea to dehydration, and hemorrhagic enteritis, ischemic enteritis and necrotic enteritis (effects on gastrointestinal tract), inhibition of bone marrow function such as pancytopenia, leucopenia, neutropenia, anemia, thrombocytopenia (effects on bone marrow), psychoneurotic symptoms such as leukoencephalopathy, extrapyramidal signs, facial paralysis, speech impairment, ataxia, nystagmus, delirium, unconsciousness, impaired orientation, hypomnesia, inactivity, unsteady gait, numbness in extremities (effects on nervous system). Based on the above information, because the information was all originated from the first prioritized information source ("List 1" as designated in the classification guidance document), the substance was classified as Category 1 (digestive system, bone marrow, nervous system). As relevant information, in the animal experiments, in mice, the lesions in the intestine, which were characterized by atrophy of epithelium and villi occurred with dose-dependency, and erythropenia and granulocytopenia in bone marrow were also observed. Moreover, it was also reported that dogs showed hyperexcitability, nervousness, muscle tremors and ataxia shortly after treatment, and that cats showed ataxia, apprehension, hyperexcitability and malacia and necrosis in the brain (IARC 26 (1981)).
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） Not classified - - - - Classified as "Not classified" from its 120h-LC50 = 2420 mg/L for fish (Pimephales promelas) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility: 11100 mg/L (PHYSPROP Database, 2011)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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