GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 6731-36-8 |
| Chemical name | 1,1-Bis(tert-butylperoxy)-3,3,5-trimethylcyclohexane |
| Substance ID | 23A5119 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government （July, 2010）
Environmental Hazards: UN GHS Document （4th revised edition） |
| 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 (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Classification not possible | - | - | - |
There are chemical groups associated with explosive properties (neighboring oxygen atoms). It is classified in class 5.2 subsidiary risk 1 in UNRTDG (16th, 2009) (UN3101 organic peroxide type B (liquid)). And this substance corresponds to explosives. But the classification in the division is not possible due to no detailed test data. Besides, the oxygen balance calculation is -248.64. |
| 2 | Flammable gases （including chemically unstable gases） | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 6 | Flammable liquids | Classification not possible | - | - | - |
Due to no data on a flash point of a pure form, the classification is not possible. Besides, data on Akzo product Trigonox 29 (purity 95%) said a flash point of 83 degrees C [closed cup] (MSDS (Akzo Nobel) (1998)). |
| 7 | Flammable solids | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 8 | Self-reactive substances and mixtures | Not applicable | - | - | - | It is classified as organic peroxides. |
| 9 | Pyrophoric liquids | Not classified | - | - | - | It was classified as "Not classified" because it is conceivable that it does not ignite at normal temperatures from SADT of 60 degrees C (140 degrees F) for Akzo product Trigonox 29 (purity 95%) (MSDS (Akzo Nobel) (1998)). |
| 10 | Pyrophoric solids | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - | No established test method suitable for liquid substances. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Classification not possible | - | - | - | An organic compound contains oxygen which is chemically bonded to oxygen atoms mutually other than carbon, but the classification is not possible due to no data. |
| 14 | Oxidizing solids | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 15 | Organic peroxides | Type B |   |
H241 |
P411+P235 P210 P220 P234 P280 P410 P420 P501 |
it was classified in type B because it is classified in class 5.2 in UNRTDG (16th, 2009) (UN3101 organic peroxide type B (liquid)). |
| 16 | Corrosive to metals | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Not classified | - | - | - | On the basis of LD50 values of >2000 mg/kg bw (Report on Toxicity Tests of Chemical Substances, MHLW (2000)) and >12918 mg/kg (PATTY (5th, 2001)) for rats, it was classified as "Not classified." |
| 1 | Acute toxicity （Dermal） | Not classified | - | - | - | On the basis of an LD50 value of > 8000 mg/kg for rats (PATTY (5th, 2001)), it was classified as "Not classified." |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | No data. |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - | No data. |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - |
Lack of data. Besides, there is the information that it is not "an irritant" in a test using rats (PATTY (5th, 2001)), but it was classified as "Classification not possible" due to unknown test details in addition to using rats as test animals. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Classification not possible | - | - | - | No data. |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - |
The classification is not possible due to no in vivo test data. Besides, negative results in both an Ames test and a chromosomal aberration test using Chinese hamster lung fibroblasts were reported as in vitro tests (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Aug. 2011)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - | No data. |
| 7 | Reproductive toxicity | Classification not possible | - | - | - | No data. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible | - | - | - |
Oral administration of 2000 mg/kg to five each of male and female rats reported that no dead case in both males and females was shown, but slightly higher incidence of diarrhea or soft stool in an administrated group was observed on a day of administration, and no abnormalities in weight changes and a necropsy in any animals on day 15 of observation were observed (Report on Toxicity Tests of Chemical Substances, MHLW (2000)). It is judged to be corresponding to "Not classified" in an oral route, but it was classified as "Classification not possible" in specific target organ toxicity (single exposure) due to no data in other routes (dermal, inhalation). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (liver, kidney) |  |
H373 |
P260 P314 P501 |
Twenty-eight-day oral administration to rats reported increases in centrilobular hypertrophy of hepatocytes and in periportal fatty degeneration in liver at 100 mg/kg (converted to a 90-day equivalent value: 31 mg/kg/day) or higher, and extended blood coagulation time and elevated GPT activity at 1000 mg/kg (converted to a 90-day equivalent value: 311 mg/kg/day), and an indication of liver damage effects (Report on Toxicity Tests of Chemical Substances, MHLW (2000)). The centrilobular hypertrophy of hepatocytes in the liver was also observed at 20 mg/kg or higher in 13-week and 52-week oral administration in rats (Report on Toxicity Tests of Chemical Substances, MHLW (2005)). The above results show effects on the liver at doses which correspond to the range of Category 2 in Guidance values, therefore, it was classified in Category 2 (liver). Furthermore, female rats show increased kidney weights at 100 mg/kg in 28-day and 52-week oral administration and significantly increased basophilic renal tubule at 100 mg/kg in 52-week oral administration, and those indicate effects on a kidney by long-term administration of test substance (Report on Toxicity Tests of Chemical Substances, MHLW (2005)). It was classified in Category 2 (kidney) because the dose corresponds to a range of Category 2 in guidance values. Besides, the Report on Toxicity Tests of Chemical Substances reports that male rats showed eosinophilic cytoplasmic inclusions or hyaline droplets in the proximal renal tubules, but humans cannot be extrapolated from those lesions because they are alpha 2u-globulin deposition specific to male rats (Report on Toxicity Tests of Chemical Substances, MHLW (2000) (2005)). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - | No data. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - | This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* 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. |
Updated date:
|
2016/8/17 Addition of Rationale for the classification |