GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 614-45-9 |
| Chemical Name | tert-Butyl peroxybenzoate |
| Substance ID | H29-B-079 |
| Classification year (FY) | FY2017 |
| 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 | FY2010 |
| 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 | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (neighboring oxygen atoms) in the molecule, and the calculated oxygen balance is -214, but the classification is not possible due to lack of data. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Category 4 |
Warning |
H227 |
P370+P378
P403+P235 P210 P280 P501 |
A flash point is 66 deg C (closed cup) (Gangolli (2nd, 1999)). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | It is classified in Organic peroxide. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 130 deg C (Hommel (1991)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid 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 | Classification not possible |
- |
- | - | It is an organic compound containing oxygen, and the oxygen is chemical bonded to each other (other than carbon), but the classification is not possible due to lack of data. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Type C |
 Danger |
H242 |
P411+P235
P210 P220 P234 P280 P410 P420 P501 |
One of concentrations of >77-100% is classified in Division 5.2, type C, in UNRTDG (UNRTDG) (UNRTDG model regulations 2.5.3.2.4). |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on a report of an LD50 value of 3,639-4,838 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification). |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a report of an LD50 value of 3,817 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification). |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 4 |
 Warning |
H332 |
P304+P340
P261 P271 P312 |
From a report that there was no death case at 1.01 mg/L (127.1 ppm), and all cases died at 4.9 mg/L (616.8 ppm) in a 4-hour inhalation test with rats exposed to the aerosol (SIAP (2014)), the LC50 value is considered to be in the range of 1.0-5.0 mg/L. Therefore, it was classified in Category 4. Besides, the reference values in the unit of mg/L as mist was applied because the exposure concentrations are higher than the saturated vapor pressure concentration (0.03 ppm). The category was changed from the previous classification since a new information source was used. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | There is a report that in a skin irritation test (equivalent to OECD TG 404) of this substance with rabbits, the mean Draize scores at 72 hours after application were 3.5 for erythema and 1.3 for edema, and moderate skin irritation was observed. On the other hand, there is a report that no irritation was observed (Draize scores not available) in another test (equivalent to OECD TG 404) (both in SIAP (2014)). Therefore, it was classified as "Classification not possible" since it was insufficient to judge the category. The category was revised based on information obtained in this research. |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | There is a report that in an eye irritation test (equivalent to OECD TG 405) of this substance with rabbits, the mean Draize scores at 72 hours after application were 0.7 for conjunctival redness and 0.7 for chemosis, and there was no eye irritation (SIAP (2014)). Also, there is a report that there was no eye irritation (Draize scores not available) in a similar eye irritation test (equivalent to OECD TG 405) with rabbits (SIAP (2014)). Therefore, it was classified as "Not classified." The category was revised based on information obtained in this research. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
Based on a description that this substance is considered to be a skin sensitizer on the basis of the result of a local lymph node test (OECD TG 429 compliant) (SIAP (2014)), it was classified in Category 1. The category was revised based on information obtained in this research. |
| 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, a micronucleus test with peripheral blood of mice was negative (NTP DB (Access on July 2017), NTP TOX15 (1992), SIAP (2014)). As for in vitro, bacterial reverse mutation tests gave positive and negative results, and a gene mutation test, a chromosomal aberration test and sister chromatid exchange tests with mammalian cultured cells were positive (PATTY (6th, 2012), NTP DB (Access on July 2017), NTP TOX15 (1992), SIAP (2014)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
In a reproduction/developmental toxicity screening test (OECD TG 421) with rats dosed by gavage, no reproductive and developmental effect was observed other than a low value of body weight in pups at 1,000mg/kg/day where one death and toxicity symptoms were observed in maternal animals (SIAP (2014)). In addition, in a developmental toxicity test in which pregnant female rats were dosed by gavage on gestational days 3-19 at up to 1,000 mg/kg/day, only slight effects (a low value of body weight, delayed ossification) unavailable for evidence of the classification were observed in fetuses even at 1,000 mg/kg/day where maternal toxicity (decreased body weight gain, decreased food consumption) was observed (SIAP (2014)). From the above, although there was no evidence of reproductive and developmental toxicity from the findings observed in experimental animals, it is insufficient to classify it as "Not classified" with only these results since this test is a screening test. Therefore, it was classified as "Classification not possible" for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (respiratory organs) |
 Warning |
H371 |
P308+P311
P260 P264 P270 P405 P501 |
There is no data on single exposure to this substance in humans. As for experimental animals, there is a report that in a 4-hour single inhalation exposure test (OECD TG 436 compliant) in aerosol with rats, at 1.01 mg/L, labored breathing and tachypnea were observed but these resolved after 3 days, and all the animals survived, but at 4.9 mg/L, all the animals died after showing the same symptoms, and an incompletely collapsed lung and reddening of the lung were observed as a result of necropsy (SIAP (2014)). These doses correspond to the guidance value range for Category 2 for dust/mist/fume. Therefore, it was classified in Category 2 (respiratory organs). The classification result was changed from the previous one by using a new information source. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
No information on humans is available. As for experimental animals, in 13-week repeated oral dose toxicity tests with rats and mice, in rats, hyperplasia of the mucosal epithelium of the forestomach at or above 30 mg/kg/day (converted guidance value: 21.7 mg/kg/day), an increase in absolute weight of the forestomach at or above 60 mg/kg/day (converted guidance value: 43.3 mg/kg/day), and inflammation of the forestomach at or above 125 mg/kg/day (converted guidance value: 90.3 mg/kg/day) were found, and in mice, hyperplasia of the mucosal epithelium of the forestomach at or above 30 mg/kg/day (converted guidance value: 21.7 mg/kg/day) was observed (NTP TOX15 (1992), PATTY (6th, 2012), SIAP (2014)). From the above, only findings in the forestomach were observed, but this was thought to be due to irritation, thus, it was not adopted as evidence of the classification. Therefore, it was classified as "Classification not possible." |
| 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 |
From 72-hour EC50 (rate method) = 0.8 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2014), 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 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 32% (J-CHECK, 1998)), and 21-day NOEC (reproduction inhibition) = 0.44 mg/L for crustacea (Daphnia magna) (OECD SIDS: 2014). 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 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 32% (J-CHECK, 1998)), and 72-hour EC50 (rate method) = 0.8 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2014). From the above results, it was classified in Category 1. |
| 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. |