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EC number: 213-147-2 | CAS number: 927-07-1
- 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:
- July 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- 5 doses were applied once only to the backs of rabbits for 24 hours and were observed the following 14 days.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- tert-butyl peroxypivalate
- EC Number:
- 213-147-2
- EC Name:
- tert-butyl peroxypivalate
- Cas Number:
- 927-07-1
- Molecular formula:
- C9H18O3
- IUPAC Name:
- tert-butyl 2,2-dimethylpropaneperoxoate
- Reference substance name:
- 2,2,4,6,6-pentamethylheptane
- EC Number:
- 236-757-0
- EC Name:
- 2,2,4,6,6-pentamethylheptane
- Cas Number:
- 13475-82-6
- Molecular formula:
- C12H26
- IUPAC Name:
- isododecane
- Test material form:
- liquid
Constituent 1
additive 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey
- Weight at study initiation: 2300 to 2805 g
- Housing: individually in hanging wire-mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 20 - 30% of body surface
- Type of wrap if used: gauze banding
REMOVAL OF TEST SUBSTANCE
- Washing: tepid tap water
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 1250; 2500; 5000; 10000 and 20000 mg/kg bw
- No. of animals per sex per dose:
- 2 animals per sex per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 24 hours and daily for 14 days
- Frequency of weighing: prior to test material administration and on day 7 and 14
- Necropsy of died animals performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 301 - < 4 806
- Mortality:
- 1250 mg/kg bw: 1/4
2500 mg/kg bw: 1/4
5000 mg/kg bw: 4/4
10000 mg/kg bw: 4/4
20000 mg/kg bw : 4/4 - Clinical signs:
- other: Animals exposed up to 2500 mg/kg bw showed dermal irritations like moderate to marked erythema, edema, desquamation and necrosis, which were not reversible until day 14.
- Gross pathology:
- The animals died during the test exposed to doses higher than 5000 mg/ kg bw showed dermal irritation and ulceration and hyperemia of mucose of the stomach and discoloration of the liver. Males were more sensitive to the test item than females.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study with TBPPI in rabbits a LD50 value of 2500 mg/kg bw was determined.
- Executive summary:
Twenty male and twenty female New Zealand White rabbits were used for an acute dermal toxicity study with TBPPI. The rabbits were divided into five groups of 2 male and 2 female rabbits each. The hair was removed from the back of each rabbit (20 -30% of the body surface) with an electric clipper. The test material was applied once only to the backs of the rabbits at the following dosage levels: 1250; 2500; 5000; 10000 and 20000 mg/ kg bw. Following dosing, the application sites were wrapped with gauze bandaging and overwrapped with Saran Wrap. 24 hours following application, the bandages were removed and the test sites were washed with tepid tap water. The rabbits were observed at 24 hours and daily thereafter for a total of 14 days for pharmacotoxic signs, mortality and dermal irritation. Body weights were recorded immediately prior to the test material administration and at 7 and 14 days of the observation period. All rabbits which died on study were subjected to gross necropsy examination.
All animals exposed to 5000 mg/kg bw and higher died during the testing period. One female and one male rabbit died in the lowest and the 2500 mg/kg bw dose level respectivly. In all surviving animals moderate to marked dermal irritation and necrosis occured and were not reversible until 14 days. Necropsy of died animals showed ulceration and hyperemia of the mucosa of the stomach and discoloration of the liver. No adverse effects on body weights of surviving animals could be observed.
The acute dermal LD50 values were 2500 mg/kg bw in males and females and the 95th confidence limits were 1250 - 5000 mg/kg bw in males and 625 - 10000 mg/kg bw in females.
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