NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	61-68-7
Chemical Name	Mefenamic acid
Substance ID	24A6028
Classification year (FY)	FY2012
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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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

PHYSICAL HAZARDS

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.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	All three LD50 values for rats corresponded to Category 4 (1420 mg/kg (Pharmaceutical Interview Forms, Bafhameritin-M Capsules 250 (revised third edition, 2009), corresponding to List 1), 780 mg/kg (males) and 740 mg/kg (females) (RTECS (2010): the original article, Journal of Medical Society of Toho University: 28, 99, (1981))).
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 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	- -	-	-	No data available.
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2, Additional category: Effects on or via lactation	Warning	H361 H362	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 based on the List 2 information that a follow-up investigation on 20 pregnant women who overdosed on this substance revealed 11 with normal offspring, two miscarriages, six elective terminations, and two infants with defects (systolic murmur, thyroglossal cyst) (Teratogenic (12th, 2007), corresponding to List 2) and the information that there is a report on the shrinkage of the ductus arteriosus in fetuses in an experiment in which rats were dosed at the end of gestation (Ethical Pharmaceuticals (2000)). And it was classified in the Additional category: Effects on or via lactation because it is described that breastfeeding should be stopped (because it is reported that it will be transferred to body milk) (Ethical Pharmaceuticals (2010)). Besides, this substance has been used as a medicine of an antipyretic or sedative, and it is described that it should be administered to pregnant women or women with the potential to become pregnant only if treatment benefits are determined to exceed the risk, and it is contraindicated in the late pregnancy (Pharmaceutical Interview Forms, Bafhameritin-M Capsules 250 (revised third edition, Aug. 2009)).
8	Specific target organ toxicity - Single exposure	Category 1 (digestive system, blood), Category 2 (nervous system)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	There is a report on cases of overdose of this substance (tablets), convulsions occurred 1 hour after ingestion of 100 tablets (50 g) in a 14-year-old girl and 3 hours after ingestion of 50 tablets (25 g) in an 18-year-old girl (HSDB (2003)), and a 19-year-old woman became status epilepticus after ingesting 12.5 g of this substance (HSDB (2003)). It is described that the lowest dose to cause seizures was 2.5 g in a 12-year-old, and four patients who ingested 5 g developed seizures (HSDB (2003)), and other symptoms such as drowsiness, dizziness, nervousness, and headache are described (HSDB (2003)). Because the above information was from List 2, it was classified in Category 2 (nervous system). On the other hand, diarrhea is common and often severe after ingesting this substance, and ulceration and bleeding of the gastrointestinal tract and pseudomembranous colitis have been reported (HSDB (2003)). It was classified in Category 1 (digestive system) because it is described that there are peptic ulcer, colitis, etc. as serious adverse effects, and gastrointestinal bleeding may occur (Ethical Pharmaceuticals (2000)). Furthermore, it was classified in Category 1 (blood) because there is a report on agranulocytosis, thrombocytopenic purpura, megaloblastic anemia, and pancytopenia (HSDB (2003)), and it is described that hemolytic anemia and agranulocytosis (autoimmune hemolytic anemia, agranulocytosis, granulocytopenia) may occur as serious adverse effects (Ethical Pharmaceuticals (2000)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney, digestive system, blood)	Danger	H372	P260 P264 P270 P314 P501	It is reported that renal failure occurred after ingesting 12-15 g of this substance over 4-5 days (HSDB (2003)). It was classified in Category 1 (kidney) because it is described in the package insert of the medicine for this substance that acute renal failure, nephrotic syndrome, interstitial nephritis (acute renal failure, nephrotic syndrome, interstitial nephritis) may occur as serious adverse effects (Ethical Pharmaceuticals (2000)). Diarrhea is common and often severe after ingesting this substance, and ulceration and bleeding of the gastrointestinal tract and pseudomembranous colitis have been reported (HSDB (2003)). It was classified in Category 1 (digestive system) because it is also described in the package insert of the medicine that there are peptic ulcer, colitis, etc. as serious adverse effects, and gastrointestinal bleeding may occur (Ethical Pharmaceuticals (2000)). Furthermore, it was classified in Category 1 (blood) because there is a report on agranulocytosis, thrombocytopenic purpura, megaloblastic anemia, and pancytopenia (HSDB (2003)), and it is described in the package insert of the medicine that hemolytic anemia and agranulocytosis (autoimmune hemolytic anemia, agranulocytosis, granulocytopenia) may occur as serious adverse effects (Ethical Pharmaceuticals (2000)).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

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	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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