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EC number: 222-389-8 | CAS number: 3457-61-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- tert-butyl α,α-dimethylbenzyl peroxide
- EC Number:
- 222-389-8
- EC Name:
- tert-butyl α,α-dimethylbenzyl peroxide
- Cas Number:
- 3457-61-2
- Molecular formula:
- C13H20O2
- IUPAC Name:
- [2-(tert-butylperoxy)propan-2-yl]benzene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals:
Species, strain: rat, Sprague-Dawley ICO: OFA-SD (IOPS Caw).
Reason for this choice: rodent species generally accepted by regulatory authorities for this type
of study.
Breeder: lffa Crédo, 69210 L'Arbresle, France.
Number and sex: one group of ten animals (five males and five females).
Age/weight: on the day of treatment, the animals were approximately 8 weeks old, and had a mean body weight ± standard deviation of 262 ± 15 g for the males and 235 ± 8 g for the females.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: the animals were identified individually by earmarks or earnotches.
Environmental conditions:
. temperature: 21 ± 2°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 hl12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording.
During the acclimatization period, one to seven animals of the same sex were housed in polycarbonate cages. During the treatment period, the animals were housed individually in polycarbonate cages.
Food and water ad libitum. No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day before treatment, the dorsal area (6 cm x 8 cm) of each animal was clipped using electric clippers. Only animais with healthy intact skin were used for the study.
The test substance was applied undiluted taking into consideration that its specific gravity was 0.932 g/ml. It was placed directly on an area of the skin representing approximately 10% (5 cm x 6 cm for the females and 5 cm x 7 cm for the males) of the body surface of the animals. A hydrophilic gauze pad was then applied to the skin. The test substance and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test substance by the animals. No residual test substance was observed at removal of the dressing. The dose applied to each animal was adjusted according to body weight determined on the day of treatment. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: historical laboratory controls
- Details on study design:
- Post observation period : 14 days.
The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
The animals were weighed individually just before administration of the test substance on day 1 and the days 8 and 15.
On day 15, all animals were killed by carbon dioxide asphyxiation and a macroscopic examination was performed. (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities). In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD0 of the test substance tert-butyl-cumyl peroxide equal to or higher than 2000 mg/kg in rats.
- Executive summary:
Peroximon 801 (96.8% tert-butyl-cumyl peroxide) was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females), in a well conducted acute dermal toxicity test (OECD 402, GLP). The application was performed with the undiluted test substance at the dose of 2000 mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance.All animals were subjected to necropsy. The general behaviour of the animals was not affected by treatment with the test substance.
A reduced weight gain or slight bodyweight loss were observed in two females during the observation period. The overall body weight gain of the ether animals was not affected by treatment with the test substance. No cutaneous reactions were observed. No death occurred at 2000 mg/kg. No apparent abnormalities were observed at necropsy. The dermal LD0 of Peroximon 801 was equal to or higher than 2000 mg/kg bw in rats.
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