GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 96-76-4 |
| Chemical Name | 2,4-Di-tert-butylphenol |
| Substance ID | H28-B-02-METI, M-002B |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2008 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 solids | 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 | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an ignition point of 330 deg C (GESTIS (Access on September 2016)). |
| 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) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
On the basis of LD50 values of 1,762 mg/kg (female) and 2,000 mg/kg (male) (OECD TG 401) for rats (JECDB (Access on September 2016)), this substance was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - |
On the basis of an LD50 value of > 5,000 mg/kg for rabbits (Hazard Assessment Report (CERI, NITE, 2009)), this substance was classified as "Not Classified." Besides, the data from RTECS (2004) used for the previous classification was not adopted because the details are unknown. |
| 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 | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
In a skin irritation test using rabbits (OECD TG 404), there is a report that moderate irritation was observed (ECHA (Access on November 2016)). Therefore, this substance was classified in Category 2. The data in IUCLID which was used for the previous classification was not adopted because it could not be obtained. Besides, in a test in which this substance was applied for 24 hours to rabbit skin, it is reported that corrosivity was shown (Hazard Assessment Report (CERI, NITE, 2009)). However, this was not adopted for the classification because it is a 24-hour application test. |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
In a test in which this substance was applied to rabbit eyes, it is reported that moderate irritation was observed (Hazard Assessment Report (CERI, NITE, 2009)). Also, as for ECHA, there are reports of two eye irritation tests using rabbits (OECD TG 405), and it is reported that irritation was observed (ECHA (Access on November 2016)). From the above, this substance was classified in Category 2A. The information on IUCLID used for the previous classification could not be confirmed because it was not available. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Negative is reported in a skin sensitization test using guinea pigs (OECD TG 406) (Hazard Assessment Report (CERI, NITE, 2009)), but this substance was classified as "Classification Not Possible" because the details of results, etc. are unknown. The information on IUCLID used for the previous classification could not be confirmed because it was not available. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. As for in vivo, there is no data, and as for in vitro, a bacterial reverse mutation test was negative and a mammalian cell chromosome aberration test was positive (JECDB (Access on September 2016), Hazard Assessment Report (CERI, NITE, 2009)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a preliminary reproduction toxicity screening test (OECD TG 421) by the oral route (gavage administration) using rats, at the dose (250 mg/kg/day) where deaths (2/12 females), decreased weight gain and tissue degeneration of liver and kidney were observed in parent animals, no effect on fertility was observed, but a decline in the live birth index, a tendency of high stillbirth rates, and a tendency of a low number of live born were observed in the offspring (JECDB (Access on September 2016)). However, with regard to these findings, the death rate of maternal animals is high at 16.7%, so they may be considered to reflect the effects of maternal toxicity, and cannot be judged as the developmental effects due to administration of this substance. Because there is no available data for the classification except the result of this screening test, this substance was classified as "Classification not possible" due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (kidney) |
 Warning |
H371 |
P308+P311
P260 P264 P270 P405 P501 |
In a single oral administration test of this substance using rats, there is a report that as a result of necropsy of survivors, grayish white spots or hypertrophy of the kidney were observed macroscopically; and basophilic renal tubules, granular cast, neutrophilic cellular infiltration, mineralization and so on were observed histopathologically at 1,280 mg/kg, which corresponds to Category 2, or above (JECDB (Access on September 2016)). Therefore, this substance was classified in Category 2 (kidney). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (kidney, blood coagulation system) |
Warning |
H373 |
P260
P314 P501 |
In experimental animals, in a 28-day repeated dose toxicity test using rats by gavage, increased total cholesterol and phospholipid and increased liver weight were observed at or above 75 mg/kg/day (converted guidance value: 23 mg/kg/day), which corresponds to Category 2; decreased hemoglobin quantity and hematocrit level, increased segmented neutrophil ratio, extension of prothrombin time and activated partial thromboplastin time, centrilobular hypertrophy of hepatocytes, basophilic renal tubule of kidney, granular cast, protein cast, neutrophilic cellular infiltration of kidney, distal tubule dilatation, proximal tubule hypertrophy and so on were seen at 300 mg/kg/day (converted guidance value: 93 mg/kg/day) (JECDB (Access on September 2016), Hazard Assessment Report (CERI, NITE, 2009), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). Besides, a questionnaire-based survey on leukoderma in the skin was carried out with workers handling rubber containing this substance; 200 people responded, and 15 people answered that they had leukoderma. After a skin check for leukoderma was performed, leukoderma was observed in 5 people. However, vitiligo was not observed in all 48 people who reported no abnormalities in their skin. It is reported that exposure to this substance was considered to be the cause of leukoderma Hazard Assessment Report (CERI, NITE, 2009), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). From the above, the effects were mainly observed in the kidney in experimental animals; otherwise, effects were seen in the liver, blood and blood coagulation system. The findings in the liver were considered as adaptive changes. With regard to the decreased hemoglobin quantity and hematocrit level, there was no influence on the number of erythrocytes, reticulocytes and bone marrow, so they were not considered as severe changes. The increase in the segmented neutrophil ratio was considered to be a change related to the effects on the kidney. In addition, the vitiligo in the skin in humans was not adopted for the classification because it was not due to exposure to this substance solely, etc. Therefore, this substance was classified in Category 2 (kidney, blood coagulation system). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 11.5 mm2.sec (60/20 degC) from the numerical data (Viscosity: 10.2 mPa*s (60 degC), density: 0.887 g/cm3 (20 degC)) listed on GESTIS (Access on September 2016). |
| 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 |
From 48-hour EC50 = 0.33 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004), Hazard Assessment Report (CERI, NITE, 2009)), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 because it is not rapidly degradable (BOD degradability: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1987)), and its 72-hour NOEC is 0.18 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004), Hazard Assessment Report (CERI, NITE, 2009)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it is not rapidly degradable (BOD degradability: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1987)), and its 48-hour EC50 is 0.33 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004), Hazard Assessment Report (CERI, NITE, 2009)). It was classified in Category 1 by drawing a comparison between the above results. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |