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EC number: 203-650-5 | CAS number: 109-13-7
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-08-24 until 1995-09-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- tert-butyl peroxyisobutyrate
- EC Number:
- 203-650-5
- EC Name:
- tert-butyl peroxyisobutyrate
- Cas Number:
- 109-13-7
- Molecular formula:
- C8H16O3
- IUPAC Name:
- tert-butyl 2-methylpropaneperoxoate
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: mean body weight of 184 ± 5 g for the males and 136 ± 4 g for the females
- Fasting period before study: 1 day
- Housing: The animals were housed individually in polystyrene cages
- Diet: A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water: drinking water filtered by a F.G. Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 30 to 70 %
- Air changes: about 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h/12 h
IN-LIFE DATES: 1995-08-24 to 1995-09-07
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- The test substance was administered in its original form taking into consideration that its density was 0.86. The volume administered to each animal was adjusted according to body weight determined on the day of treatment. - Doses:
- 2000 mg/kg in active material (i.e. corresponding to 2642 mg/kg in finished product)
- No. of animals per sex per dose:
- 5 rats per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of the animals was made at least once a day. The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination - Statistics:
- No
Results and discussion
- Preliminary study:
- No
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Two out of five females were found dead on day 2 or 3.
- Clinical signs:
- other: In the males, sedation was observed one hour after treatment, and then piloerection and hypoactivity which persisted for four hours. Thereafter, no clinical signs were noted. In the females, sedation was noted one hour after treatment, in addition to pilo
- Gross pathology:
- Macroscopic examination of the main organs of the animals demonstrated no apparent abnormalities.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study LD50 of > 2000 mg/kg was determined.
- Executive summary:
The test substance, tert-butyl peroxyiisobutyrate (TBPIB) 75.7 % in hydrocarbon was administered by oral route to one group of ten fasted Sprague-Dawley rats (five males and five females). according to OECD 401 and EU method B1 guidelines. The test substance was administered in its original form, by gavage, at a dose of 2000 mg/kg in active material. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single administration of the test substance. All animals were subjected to necropsy.
The body weight gain of the animals was not affected by treatment with the test substance. Two out of five females were found dead on day 2 or 3. In the males, sedation was observed one hour after treatment, and then piloerection and hypoactivity which persisted for four hours. Thereafter, no clinical signs were noted. In the females, sedation was noted one hour after treatment, in addition to piloerection and dyspnea two hours after; then, hypoactivity and piloerection were noted after four hours. Thereafter, no clinical signs were noted, except coma in one out of five females on day 2 prior to death on day 3. No abnormalities were observed at necropsy.
Under the study experimental conditions, the oral LD50 of the test substance was higher than 2000 mg/kg in rats.
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