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EC number: 213-626-6 | CAS number: 995-33-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Butyl 4,4-bis(tert-butyldioxy)valerate
- EC Number:
- 213-626-6
- EC Name:
- Butyl 4,4-bis(tert-butyldioxy)valerate
- Cas Number:
- 995-33-5
- Molecular formula:
- C17H34O6
- IUPAC Name:
- butyl 4,4-bis(tert-butylperoxy)pentanoate
- Test material form:
- other: colorless 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: Iffa Credo, 69210 L'Arbresle,. France.
- Age at study initiation: 8 weeks old
- Weight at study initiation: of 252 ± 10 g for the males and 225 ± 11 g for the female
- Housing: individually in polycarbonate cage
- Diet: A04 C pelleted diet, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back, approximately 7 cm x 5 cm for males and 6 cm x 5 cm for females
- % coverage: ca. 10
- Type of wrap if used: aerated hypoallergenic dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no - Duration of exposure:
- 24 hours
- Doses:
- 2000 and 4000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- CLINICAL EXAMINATIONS
Morbidity and mortality
Each animal was checked for mortality and morbidity, once a day during the acclimation period, frequently during the hours following administration, then once a day until the end of the observation period, including weekends.
Clinical signs
Each animal was observed after treatment as follows:
at least once during the first 30 minutes, periodically during the first 4 hours, then once a day, at approximately the same time, for the recording of clinical signs.
Any clinical signs observed were recorded individually for each animal, along with the times of onset and recovery.
Body weight
The body weight of each animal was recorded on the day of group allocation then on the day of treatment and on Days 8 and 15.
The body weight gain of the test item-treated animals was compared to that of CiToxLAB France historical control data generated from animals of the same strain and age treated with drinking water treated by reverse osmosis under similar experimental conditions.
PATHOLOGY
Euthanasia
On completion of the observation period, all animals were deeply anesthetized by an intraperitoneal injection of pentobarbital sodium and euthanized by exsanguination.
Macroscopic post-mortem examination
A macroscopic post-mortem examination was performed on all animals. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. All gross observations were recorded individually for each animal.
Preservation of tissues
For all animals, the macroscopic lesions were preserved in 10% buffered formalin.
Any histological specimens (tissues in fixative) were destroyed at the finalization of the study report.
Microscopic examination
No microscopic examination was performed. - Statistics:
- None
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 4 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- Di-n-butyl-4,4'-Di(tert-butylperoxy)
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- No clinical signs and no cutaneous reactions were observed during the study.
- Body weight:
- A reduced weight gain or a slight body weight loss was seen in females given 4000 mg/kg.
The body weight gain of the other treated animals was similar to that of CIT historical control animals - Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnorrnalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The derrnal LD0 of LUPEROX 230M50 is equal to or higher than 4000 mg/kg in rats, which corresponds to a dose-level of 2000 mg/kg of Di-n-butyl-4,4'-Di(tert-butylperoxy).
- Executive summary:
The acute dermal toxicity of LUPEROX 230M50 was evaluated in rats according to OECD guideline No. 402 and the principles of Good Laboratory Practice Regulations. The test substance was applied at the dose-levels of 2000 mg/kg and 4000 mg/kg to the skin of groups of ten Sprague-Dawley rats (five males and five females each). The application was performed with the undiluted test substance, taking into consideration that its specific gravity was 0.84 g/ml. 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.
No clinical signs and no deaths were observed during the study. No cutaneous reactions were observed. A reduced weight gain or a slight body weight loss was seen in females given 4000 mg/kg. The body weight gain of the other animals was not affected by treatment with the test substance. No apparent abnormalities were observed at necropsy in any animal.
The dermal LD0 of LUPEROX 230M50 is equal to or higher than 4000 mg/kg in rats, which corresponds to a dose-level of 2000 mg/kg of Di-n-butyl-4,4'-Di(tert-butylperoxy).
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