GHS Classification Result
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
Reference：
Chemical Name：Butylated hydroxyanisole(BHA)
CAS：25013-16-5
Result：
| ID: | 20 |
| Classifier: | Ministry of Economy, Trade and Industry （METI） |
| Year Classified: | FY2007 |
| 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 | - | - | - | - | - | - |
| 2 | Flammable gases （including chemically unstable gases） | - | - | - | - | - | - |
| 3 | Aerosols | - | - | - | - | - | - |
| 4 | Oxidizing gases | - | - | - | - | - | - |
| 5 | Gases under pressure | - | - | - | - | - | - |
| 6 | Flammable liquids | - | - | - | - | - | - |
| 7 | Flammable solids | - | - | - | - | - | - |
| 8 | Self-reactive substances and mixtures | - | - | - | - | - | - |
| 9 | Pyrophoric liquids | - | - | - | - | - | - |
| 10 | Pyrophoric solids | - | - | - | - | - | - |
| 11 | Self-heating substances and mixtures | - | - | - | - | - | - |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | - | - | - | - | - | - |
| 13 | Oxidizing liquids | - | - | - | - | - | - |
| 14 | Oxidizing solids | - | - | - | - | - | - |
| 15 | Organic peroxides | - | - | - | - | - | - |
| 16 | Corrosive to metals | - | - | - | - | - | - |
| 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. | From LD50=2,578 mg/kg obtained by application of formula based on LD50 4,000 mg/kg (PATTY (5th, 2005)), 5,000 mg/kg (PATTY (5th, 2005)), 2,500 mg/kg (PATTY (5th, 2005)), 2,200 mg/kg (HSDB (1995)), 2,200 mg/kg (JECFA (1980)), and 5,000 mg/kg (JECFA (1980)) of an oral administration test employing a rat , it classified into Category 5. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | - | Classification not possible due to lack of data |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | - | Since it was a solid by the definition of GHS, it was classified into "Not applicable". |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | - | Classification not possible due to lack of data |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | - | Classification not possible due to lack of data |
| 2 | Skin corrosion/irritation | Not classified | - | - | - | - | PATTY (5th, 2005) describes "BHA is not an irritating substance." Since many data such as "minimal" or "slight" skin stimulation," no skin irritation" are found as a result of detailed check of the cited literature, it was classified into "Not classified". |
| 3 | Serious eye damage/eye irritation | Not classified | - | - | - | - | PATTY (5th, 2005) describes that "BHA is not a stimulator substance." . Since there is a description that the eye irritation in the rabbit exposed to BHA is "minimal ", or a report that symptoms, such as conjunctival redness, iritis, are not seen as a result of close investigation of the cited literature, it was classified into "Not classified ". |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | - | Although it has been reported in the cited literature of PATTY (5th, 2005) that a flare-up of symptoms was observed in oral exposure to patient with a history of rhinitis and asthma and a suspected allergy of BHA, the data is not one of inhalation exposure. Moreover, it cannot be employed since it is unknown what kind of allergy is possessed. It was classified into "Classification not possible" because of insufficient data since there is no other data of the respiratory sensitization by inhalation exposure. |
| 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 ... |
It is reported in JECFA (1980) that skin sensitization was observed in the patch test (112 persons). Moreover, PATTY (5th, 2005) also had a statement on human allergic contact dermatitis and, since it was discovered by scrutinizing the cited literature that skin sensitization had been observed in the 548 persons' patch test, it was defined as Category 1. In addition, two or more cases of contact dermatitis from BHA in cosmetics or hand cream have also been reported in this reference. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - | - | Since it was negative in the in vitro reverse mutation test employing bacteria and in the in vivo micronucleus test employing rat bone marrow blood glomus cells (NTP DB (Access on January 2008)), it was classified into "Not classified". |
| 6 | Carcinogenicity | Category 2 |
|
Warning | H351: Suspected of causing cancer |
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 was defined as Category 2 based on the fact that it was classified as Group2B by IARC 40 and that the tumor in anterior stomach was reported in rats exposed to 1% (corresponding value in rats = 500-1000 mg/kg) mixed with foods by JECFA (1989). |
| 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 ... |
Although neurobehavioral effects such as increase of exploratory activities and decrease of homing responses were observed among mice orally exposed before and after birth, there is no description about parent animals' general toxicity. (PATTY (5th, 2005)). Since no description was found about parent animals' general toxicity as a result of thorough review of the primary litrature (Stokes & Scudder (1974)), it was classified in Category 2. Mice had been exposed from before birth till the study period (6-7 weeks old age) after weaning. Incidentally, it has been reported that teratogenicity caused by exposure was not observed (JECFA (1983)) and no adverse effect on reproductive functions was found in the 3 generation rat-reproduction study (JECFA (1980)). |
| 8 | Specific target organ toxicity - Single exposure | Category 3 （Narcotic effects） |
|
Warning | H336: May cause drowsiness or dizziness (narcotic effects) |
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. P405: Store locked up. P501: Dispose of contents/container to ... |
Since drowsiness was observed in humans orally exposed by BHA (JECFA (1980)), it was classified into Category 3 (Narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Not classified | - | - | - | - | Although increases in the weight volume ratio of the liver were seen in some of the rats who were fed 0.5% (equivalent to 250-500 mg/kg), which exceeded the guidance values, no histological changes were observed in the liver, kidney, lien, etc. (JECFA (1980)), so it was classified into "Not classified". |
| 10 | Aspiration hazard | Classification not possible | - | - | - | - | Classification not possible due to lack of data |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | - | - | - | - | - | - |
| 11 | Hazardous to the aquatic environment （Long-term） | - | - | - | - | - | - |
NOTE:
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* 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：
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Reference Manual |
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Definitions / Abbreviations |
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Model Label by MHLW |
MHLW Website （in Japanese Only） |
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Model SDS by MHLW |
MHLW Website （in Japanese Only） |