GHS Classification Result

Chemical Name：4,4'-Isopropylidenediphenol; Bisphenol A
CAS：80-05-7

Result：
ID: 353
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 Not applicable - - - - Containing no chemical groups with explosive properties
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Classified as "solid" according to GHS definition
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Classified as "solid" according to GHS definition
5 Gases under pressure Not applicable - - - - Classified as "solid" according to GHS definition
6 Flammable liquids Not applicable - - - - Classified as "solid" according to GHS definition
7 Flammable solids Classification not possible - - - - No data available
8 Self-reactive substances and mixtures Not applicable - - - - Containing no chemical groups with explosive or self-reactive properties
9 Pyrophoric liquids Not applicable - - - - Classified as "solid" according to GHS definition
10 Pyrophoric solids Not classified - - - - Not pyrophoric when in contact with air at ordinary temperatures: the auto-ignition temperature is 600degC (ICSC, 1999)
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 - - - - Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)
13 Oxidizing liquids Not applicable - - - - Classified as "solid" according to GHS definition
14 Oxidizing solids Not applicable - - - - Organic compounds containing oxygen (but not fluorine and chlorine), with the oxygen bound to carbon and hydrogen (but not to other elements)
15 Organic peroxides Not applicable - - - - Organic compounds containing no "-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 5 - Warning H303: May be harmful if swallowed P312: Call a POISON CENTER or doctor/physician if you feel unwell. Based on the testing data of rat LD50 (oral route) of 3,300mg/kg representing the lowest fixed value of the testing data, 3,300mg/kg, 4,100mg/kg and approximately 5,000mg/kg (EU-RAR No.37 (2003)).
1 Acute toxicity （Dermal） Category 5 - Warning H313: May be harmful in contact with skin P312: Call a POISON CENTER or doctor/physician if you feel unwell. Based on the testing data of rabbit LD50 (dermal route)of >2,000mg/kg, >6,400mg/kg (EU-RAR No.37 (2003)); while definite classification is not possible because of the absence of a fixed value, an administration of 2,000mg/kg resulted in the death of 3/15 specimens.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Due to the fact that the substance is "solid" according to the GHS definition and inhalation of its gas is not expected.
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - Based on the results of rat inhalation exposure: LC50 (6 hours)=>0.17mg/L (EU-RAR No.37 (2003)). While an LC50 value (4 hours) calculated at >0.26mg/L suggests the classification into Category 2, "Classification Not Possible" seems appropriate because of the absence of a fixed value.
2 Skin corrosion/irritation Not classified - - - - Based on the description in the report on rabbit primary skin irritation tests (4 hour dermal application) (EU-RAR No.37 (2003): Bisphenol A does not cause skin irritation, given the absence of skin reactions such as erythema and edema.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		Based on the description in the report on rabbit eye irritation tests EU-RAR No.37 (2003): Corneal opacity and iritis are observed for 28 consecutive days in one out of three specimens; the substance, though not corrosive, causes severe eye irritation.
4 Respiratory sensitization Classification not possible - - - - No data available
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		Based on the description in EU-RAR No.37 (2003) (guinea pig skin sensitization tests and reports on human cases suggest that bisphenol A may cause skin sensitization) and the classification by the Japanese Society of Contact Dermatitis (skin sensitization, positive).
5 Germ cell mutagenicity Not classified - - - - Based on the absence of data on germ cell multi-generation mutagenicity tests in vivo/mutagenicity tests (dominant lethal tests show negative, which according to EU-RAR is unreliable, and hence cannot serve as a basis for classification.) and negative data on somatic cell mutagenicity tests in vivo (micronucleus tests), described in EU-RAR No.37 (2003), CERI-NITE Hazard Assessment No.4 (2005).
6 Carcinogenicity Classification not possible - - - - Based on expert judgment, given the absence of existing classification and the testing data on NTP toxicity tests.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 ... 		A decrease in the number of newborns was observed in both rat three-generation study and mouse two-generation study, as well as a decrease in the weights of seminal vesicle and epididymis, and effect on the sperm in mice. These effects were seen in the presence of maternal toxicity or general parental toxicity, otherwise no data is available on the parental toxicity. Therefore the substance has been classified as Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory system), Category 3 (narcotic effects) Danger
Warning 		H370: Causes damage to organs (respiratory system)
H336: May cause drowsiness or dizziness (narcotic effects) 		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 ...
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.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell. 		Based on the evidence from animal studies including "somnolency, debility, slight reddening in the nasal epithelial tissue, formation of a small ulcer in the nasal tract" (EU-RAR No.37 (2003)). Although there is the description "a small ulcer" in the text, the substance is not considered to case respiratory irritation because of the formation of an ulcer. The effects were observed at dosing levels within the guidance value ranges for Category 1.
9 Specific target organ toxicity - Repeated exposure Category 2 (respiratory system, liver, kidney) Warning H373: May cause damage to organs through prolonged or repeated exposure (respiratory system, liver, kidney) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		Based on the evidence from animal studies including "reddening in the nasal epithelial tissue, formation of an ulcer in the nasal tract, morphologic lesions in the liver, kidneys and lungs (EU-RAR No.37 (2003)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 2.
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） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		It was classified into Category 2 from 96 hours LC50=1100microg/L of the crustacea (Mysid Shrimp)) (MOE Risk Assessment vol. 3 (2004) and others.).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Since it had potential to rapidly degrade (biodegradation of bisphenol-A begins after 2-4 days in the water and the decomposition by TOC: 76% (average of 18 days after) (CERI/NITE Hazard Assessment Report (2005))), and bioaccumulation was low (BCF=67.7 (Existing Chemical Safety Inspections Data)), it was classified into Not classified.


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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