NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	51-21-8
Chemical Name	5-Fluorouracil
Substance ID	m-nite-51-21-8_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing fluorine and oxygen which are chemically bonded only to carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on the rat LD50 values of 230 mg/kg (HSDB (2007)), the substance was classified into Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (gastrointestinal system, bone marrow, nervous system)	Danger	H372	P260 P264 P270 P314 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	Classified as "Not classified" from its 120h-LC50 = 2420 mg/L for fish (Pimephales promelas) (AQUIRE, 2011).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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