GHS Classification Result

Chemical Name:Warfarin
CAS:81-81-2

Result:
ID: 643
Classifier: Inter-ministerial Committee on GHS
Year Classified: FY2006
Reference Manual: GHS Classification Manual (10 Feb, 2006)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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.
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 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.
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 metaloids(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 - - - - 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).
15 Organic peroxides Not applicable - - - - Organic compounds containing no -0-0- 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 ...
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.
1 Acute toxicity (Dermal) Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
It was set as Category 4 based on rat LD50 = 1400mg/kg (ACGIH (2001)).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 1 Danger H330: Fatal if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available
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.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available
4 Respiratory sensitization Classification not possible - - - - No data
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.
5 Germ cell mutagenicity Classification not possible - - - - No data available
6 Carcinogenicity Classification not possible - - - - No data available
7 Reproductive toxicity Category 1A 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 ...
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.
8 Specific target organ toxicity - Single exposure Category 1 (blood system) Danger H370: Causes damage to organs (blood system) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system, bone, skin), Category 2 (liver, kidney) Danger
Warning
H372: Cause damage to organs through prolonged or repeated exposure (blood system, bone, skin)
H373: May cause damage to organs through prolonged or repeated exposure (liver, kidney)
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 ...
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) .
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 - - - - Insufficient data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - Classification not possible due to lack of data


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 SDS by MHLW

MHLW Website (in Japanese Only)


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