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EC number: 234-042-8 | CAS number: 10508-09-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: GLP, OECD 402 Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Di-tert-pentyl peroxide
- EC Number:
- 234-042-8
- EC Name:
- Di-tert-pentyl peroxide
- Cas Number:
- 10508-09-5
- Molecular formula:
- C10H22O2
- IUPAC Name:
- 2-methyl-2-[(2-methylbutan-2-yl)peroxy]butane
- 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:
- TEST ANIMALS
- Source: Charles River Laboratories, lnc., Portage, Michigan.
- Weight at study initiation:270-294 g (male) / 210-217 g (female)
- Housing: individually, individually in suspended stainless steel cages
- Food and water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 52-74 °F
- Humidity (%): 52 to 76
- Air changes (per hr): 10-15 cycles/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10% of the total body surface of the animals
- Type of wrap if used: gauze pad held in contact with the skin by means of anadhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE
After an approximate 24-hour exposure period, the gauze dressing, plastic and elastic wrap were removed and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with distilled water.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg - Duration of exposure:
- 24H
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* Clinical signs and mortality twice daily on day 0 and then once daily
* Body weight measured just before administration then on days 0, 7 and 14
* Animals were examined for erythema and edema following patch removal on study day 1 and daily thereafter (days 2-14)
- Necropsy : All limit test animals were euthanized (carbon dioxide inhalation) at study termination (day 14) and necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained.
The temperature and relative humidity of the animal room (62-74°F and 52-76%, respectively) exceeded the ranges specified in the protocol (61-73°F and 40-70%, respectively) during this study. These ocurrences are considered to have had no adverse effect on the outcome of this study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area, which occurred during the 24 hour exposure period. Dermal irritation was noted at the site of test article application.
- Gross pathology:
- No gross pathology was found at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these experimental conditions, the dermal LD0 of di-tert-amyl peroxide is more than 2000 mg/kg in rats.
- Executive summary:
The acute dermal toxicity of Di-tert-amyl peroxide was evaluated in rats according to a method similar to OECD 402 . The test item was applied to the skin of ten Sprague-Dawley rats (five males and five females) at the dose-level of 2000 mg/kg in semi-occlusive dressing for 24 hours. Animals were then observed during 14 days for mortality, clinical signs, effects on body weight and then necropsied. No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area, which occurred during the 24 hour exposure period. Dermal irritation was noted at the site of test article application. Body weight loss was noted for two female rats during the study day 0-7 interval and for one female during the study day 7-14 interval. Body weight gain was noted for all other animals during the test period. No significant gross internal findings were observed at necropsy on study day 14. Under the experimental conditions, the dermal LD0 of the test item Di-tert-amyl peroxide is higher than 2000 mg/kg in male/female rats.
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