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EC number: 274-919-2 | CAS number: 70833-40-8
- 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:
- 14 Days (Main Study)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study done according to OECD guideline 401. Has supporting documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 1. the relative humidity was on 4 occasions for periods between 8 and 16 hours below 30%. 2.Due to an infection with a virus at the animal breeder, the main study was performed with Sprague-Dawley rats instead of the protocolled Wistar rats.
- Principles of method if other than guideline:
- A prelimiary study was conducted using only one male and one female per dose level at 1800, 2400, 3200, 4200 and 5000 mg/kg body weight. No mortality was observed. therefore the main study was a limit dose study at 5000mg/kg.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate
- EC Number:
- 274-919-2
- EC Name:
- O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate
- Cas Number:
- 70833-40-8
- Molecular formula:
- C14H28O4
- IUPAC Name:
- 2-ethylhexyl (1,1-dimethylpropylperoxy)formate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Name: tert. amyl peroxy-2-ethyl hexyl carbonate
Batch: 850213/14/18
Purity: 93.8%; major impurities: 2-ethylhexanol, tert. amyl a 1 coho 1 and d i tert. amyl peroxide
925 kg/m3 (20°C)
10% (W/W) in DMSO at 20°C Stable for more than a year at 4°C; recovery from saturated solutions in DMSO at 20°C 95% after 7 days
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Ten young adult rats of the Sprague-Dawley strain (SPF-qual ity, randomly bred) were obtained from Iffa-Credo, Brussels, Belgium. The body weights
of the males on day 0 ranged from 264 to 285 9 and those of the females from 188 to 205 g. Date of arrival at the animal house: October 30, 1985.
The quarantine period was 7 days. Six days prior to dosing the animals were individually housed in Macrolon cages (acclimation period). The bedding material, purified sawdust (Woody Clean), was received from The Broekman Institute, Someren, The Netherlands. The animals had free access to tap-water and standard laboratory animal diet (RMH-B, pellet diameter 10 mm), which was obtained from Hope Farms, Woerden, The Netherlands. The animal room temperature was maintained at 20-25°C and the relative humidity at 25-70 percent. The artificial light sequence was 12 hours light, 12 hours dark. Feed was withheld overnight before dosing till approximately 4 hours after administration of the test substance.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test substance was removed from storage and was immediately dosed as such as a single dose using a stomach cannula. The dose volume was 5.405 ml/kg body weight.
- Doses:
- Range Finding: 1800, 2400, 3200, 4200 and 5000 mg/kg body weight
Main Study: 5000 mg/kg body weight - No. of animals per sex per dose:
- Range Finding: 1 male; 1 female
Main Study: 5 male; 5 female - Control animals:
- no
- Details on study design:
- 4.2.1 Dose selection
Based on the absence of toxicity in the dose range finding investigation only one group of animals, comprising 5 males and 5 females, was dosed with a single oral dose of the test substance at 5000 mg/kg body weight.
4.2.2 CIinical observations.
No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period with exception of four animals which occasionally showed diarrhoea on days 0 through 2. Weekly group mean body weight ga in was normal. There was no evident sex reIated effect.
4.2.3 Pathology report
Macroscopic examination of animals at the end of the study revealed no test substance related gross abnormalities. Enlarged cervical Iymph node,
observed in one animal, was considered incidental and not test substance related.
4.2.4 Calculation of the LD50 value
Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg body weight. - Statistics:
- none
Results and discussion
- Preliminary study:
- Range Finding: 1800, 2400, 3200, 4200 and 5000 mg/kg body weight
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- none
- Other findings:
- No mortalities occurred and no evident
signs of systemic toxicity were observed during the 13-day observation period with exception of the male of the 3200 mg/kg group which showed
slight diarrhoea on days 0 and 1, and the male of the 4200 mg/kg group which was slightly apathetic on day 1. Macroscopic examination of all
animals at autopsy revealed no gross abnormalities with exception of the male of the 5000 mg/kg group which showed a slightly increased blood
circulation of the stomach wall.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Since no mortal ities occurred, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg body weight.
- Executive summary:
One group of Sprague-Dawley rats, each comprising 5 males and 5 females, received a single oral dose of tert. amylperoxy-2- ethylhexylcarbonate at 5000 mg/kg body weight. No mortalities occurred and, with exception of occasional diarrhoea in the beginning of the study, no signs of systemic toxicity were observed during the 14-day observation period. Weekly group mean body weight gain was normal. There was no evident sex related effect. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg body weight.
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