NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	81-81-2
Chemical Name	Warfarin
Substance ID	m-nite-81-81-2_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	Classification not possible	- -	-	-	Classification not possible due to lack of data, though the substance contains unsaturated C=C bonds as chemical groups associated with explosive properties present.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Classification not possible due to lack of data, though the substance contains unsaturated C=C bonds as chemical groups with self-reactive properties present.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 metaloids(B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen (but not chlorine and fluorine) and the oxygen is chemically bonded only to carbon and hydrogen (but not to other elements).	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no -0-0- structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2006	GHS Classification Manual （10 Feb, 2006）
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 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	It was set as Category 2 based on LD50=25.7 mg/kg calculated from nine data of rats (EHC 175 (1995), ACGIH (2001), PIMs (1997)). In addition, this product has hight influenced factors and LD50 value has also quite large range.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	It was set as Category 4 based on rat LD50 = 1400mg/kg (ACGIH (2001)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Since the saturated vapor pressure concentration of this product is 89.8ppm, it is thought that the inhalation test was done with vapor. It was classified as Category 1 based on LC50 = 25.38ppm (ACGIH (2001)) obtained in rat inhalation test.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	There are statements of producing severe dermatitis, producing a necrosis on the skin, etc. (ACGIH (2001), HSDB (2005)). But it is unknown whether it is the result of contacting the skin, and data is insufficient, it cannot be classified.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Classification not possible	- -	-	-	Although there is a statement nothing the skin hypersensitivity by WARUFARIN(HSDB (2005)), it is unknown whether it was caused by the cutaneous contact. Since data is insufficient, it cannot be classified.	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Category 1A	Danger	H360	P308+P313 P201 P202 P280 P405 P501	It is classified into Category1A based on many statements of disordering on child growth and generatind in humans (EHC 175 (1995), ACGIH (2001), PIMs (1997), HSDB (2005)). In addition, there is a classification of Repr.Cat.1;R61 by EU.	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 1 (blood system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Although any symptom hardly appears immediately with a single injection or intake according to in-human trials or case reports, it is obvious that it has an effect on blood clotting, judging from the statement that decrease of prothrombin concentration in blood and extension of prothrombin time were observed (EHC 175 (1995), PDs (2006), PIMs (1997), HSDB (2005)). Moreover, there is a description that the acute effect which appears after a single injection or injection for several days results from the bleeding and increase of bleeding tendency caused by the prothrombin inhibition. While there are reports on many bleeding cases (EHC 175 (1995), PIMs (1997), HSDB (2005)), and a statement that the target is the blood system (PIMs (1997)). It was set as Category 1(blood systems) based on the above information.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, bone, skin), Category 2 (liver, kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In WARFARIN repeated exposure to humans, the coagulation defects by decreasing in prothrombin causes bleeding in different organs and also many symptoms accompanying it are seen. As a bleeding part, many organs and tissues, such as mucous membrane of gingiva and nose, gastroenteric tract, liver, brain, spinal epidural, urinary system and subcutaneous are described (EHC 175 (1995), ACGIH (2001), PDs (2006), PIMs (1997)). It was classified to as Cattegory 1 (blood systems) based on these informations. Based on the statement that since the little decrease of vitamin K concentration caused osteoporosis in humans, long-term treatment of low dose with anticoagulants may have a negative impacts on bone metabolism (EHC 175(1995)), it was classified to Category 1 (bone). Also in an animal, although it cannot be compared with a guidance value because of unknown dose or dosed through hypodermic injection, there is a statement of the bone loss (EHC 175 (1995)) and bone weakening by the cancellous bones loss (HSDB (2005)) etc. Moreover, it was classified to as Category 1 (skin) based on the statement that the skin necrosis ("WARFARIN induced skin necrosis") is known as one of the side effects of WARFARIN in humans (EHC 175 (1995), PDs (2006)) . Based on the statement of possibility of affction to liver and kidney (HSFS(2005)), it was classified to as Category 2 (liver, kidney) .	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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)	Classification not possible	- -	-	-	Insufficient data available.	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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.

To GHS Information