Item | Information |
---|---|
CAS RN | 128-37-0 |
Chemical Name | 2,6-tert-Butyl-p-cresol; Dibutylhydroxytoluene; BHT |
Substance ID | 25B0034 |
Classification year (FY) | FY2013 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | Revised |
Classification result in other fiscal year | FY2006 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance by the Japanese Government (July, 2013) |
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 |
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 solid | 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. Because an autoignition temperature of 345 deg C (GESTIS (Access on September 2006)) described in the previous classification could not be confirmed, the classification was not possible. |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not 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 in the molecule. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | There are reports on five LD50 values for rats (890 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), 1,700-1,900 mg/kg (DFGOT vol. 23 (2007)), 2,450 mg/kg (DFGOT vol. 23 (2007)), > 2,930 mg/kg (SIDS (2002)), and > 10,000 mg/kg (SIDS (2002))), but a report on 890 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)) was not adopted because the details are unknown. Therefore, it was classified as "Not classified" to which three out of four corresponded. |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | It was classified as "Not classified" because it is reported that an LD50 value for rats was > 2,000 mg/kg, and there was no death or toxic signs after dosing at 2,000 mg/kg (SIDS (2002)). The classification was changed from Category 5 to "Not classified" according to the Classification JIS. |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is described that there was very slight irritation in an occlusive application test with rabbits, and it was slightly irritating in humans (SIDS (2002)). It was classified as "Not classified" in the Classification JIS (Category 3 in UN GHS classification) based on the above information after removing the Chemical Substance Hazard Data (CERI, 1997) listed in List 3. |
3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
It was classified in Category 2B because it is described that in a Draize test with rabbits, slight inflammation in the conjunctiva was observed in 6/6 animals 24 hours after the application of 100 mg of this substance, but this disappeared completely after 72 hours (SIDS (2002)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. It is described in SIDS (2002) and IUCLID (2000) that it was negative in a test with guinea pigs, which was regarded as limited data in SIDS (2002). Furthermore, as for humans, it is described in SIDS (2002) that patch test results in many workers or patients were all negative, but the sensitizing potential of this substance could not be fully excluded. It was classified as "Classification not possible" by reviewing the information obtained after removing Chemical Substance Hazard Data (CERI, 1997) in List 3. |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it is reported that it was negative in all of a mutual translocation test with mice, dominant lethal tests with mice and rats, a specific locus test with mice, a micronucleus test with mouse bone marrow cells, and chromosomal aberration tests with bone marrow cells of mice and rats (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008), SIDS (2002)). As for in vitro, a positive result was observed at a cytotoxic concentration in a gene mutation test with cultured mammalian cells, but it was negative in a bacterial reverse mutation test, and in-vitro chromosomal aberration tests were partly positive (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008), SIDS (2002), ACGIH (7th, 2001), NTP DB (2013)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | It was classified as "Classification not possible" because it is classified in Group 3 by IARC (IARC 40 (1987)) and A4 by ACGIH (ACGIH (1995)). The category was changed according to the revised GHS classification guidance for the Japanese government. |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In a feeding three-generation test with mice, no reproductive or developmental toxicity was observed in either generation, but in a feeding two-generation test with rats, a decreased litter size was observed at a dose where no general toxicity was seen in F0 (SIDS (2002)). Oral administration to pregnant mice and rats did not cause developmental toxicity, and only delayed progression of ossification was found in fetuses at the doses where maternal animals showed severe toxicity (mortality 10% or above) (SIDS (2002)). Therefore, this substance was thought not to cause developmental toxicity. Fertility effects were observed in rats but not in mice, therefore it was classified in Category 2. Besides, as for data of the two-generation test with rats, data in the information source in List 3 were adopted and used in the previous classification. However, the classification result was changed because data in SIDS were adopted this time, and the classification was conducted according to the revised GHS classification guidance for the Japanese government. Furthermore, anophthalmia and microphthalmia, which were the rationale for the previous classification, were removed because they were denied in IARC 40 (1986). |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
It was classified in Category 1 (nervous system) because it is described that two women who ingested 4 g or 80 g of this substance developed epigastric cramping, nausea, vomiting, general weakness, and neurologic symptoms (SIDS (2002), ACGIH (7th, 2001)), and ingestion causes abdominal pain, confusion, dizziness, nausea, and vomiting in humans (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). |
9 | Specific target organ toxicity - Repeated exposure | Category 2 (lung, liver) |
Warning |
H373 |
P260
P314 P501 |
There are no reports in humans. In a 4-week dermal administration test with mice, congestion and enlargement of the lung and necrosis and degeneration of the alveolar epithelial cells were observed at the dose (45 mg/kg/day (converted guidance value)) within the guidance value range for Category 2 (SIDS (2002)). Furthermore, it is described that in a breeding test with rats by diet administration (dosing period: for five weeks before mating and during mating for males and females, additionally until weaning of F1 offspring for females), tissue changes in the liver (centrilobular enlargement of hepatocytes, eosinophilia, bile duct proliferation) and hyperactivity of the thyroid were found at the dose (100 mg/kg/day) within the guidance value range for Category 2 (SIDS (2002), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Among these findings, hyperactivity of the thyroid was judged to be insufficient evidence to adopt the thyroid as the target organ because the details of a histopathological picture and the grade of hyperactivity are unknown. As a result, it was classified in Category 2 (lung, liver). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | Category 1 |
Warning |
H400 |
P273
P391 P501 |
It was classified in Category 1 from 48-hour EC50 = 0.84 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999); Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). |
11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
It was classified in Category 1 due to its being not rapidly degradable (a degradation rate by BOD: 4.5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and ELS NOEC = 0.053 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2007)). |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
|