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EC number: 213-944-5 | CAS number: 1068-27-5
- 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:
- from 2003-01-15 to 2003-01-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (June 1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (July 2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide
- EC Number:
- 213-944-5
- EC Name:
- Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide
- Cas Number:
- 1068-27-5
- Molecular formula:
- C16H30O4
- IUPAC Name:
- 2,5-bis(tert-butylperoxy)-2,5-dimethylhex-3-yne
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar strain Crl:(WI) BR (outbred, SPE-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: Body weight variation did not exceed ± 20 % of the sex mean
- Housing: Animals were individually housed in labbelled Macrolon cages (type III, height 15 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Identification: Earmark
- Diet: Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany)
- Water: Free access to tap-water.
- Acclimation period: At least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 15 per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Method: dermal application
- Area of exposure: One day before exposure (day -1) an area of approximately 5x7 cm on the back of animal was clipped.
- % coverage: The test substance was applied in an area approx. 10 % of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females.
- Type of wrap: The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D, Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, minnesota, U.S.A. (Caban & Micropore)), successively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionaly used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing: the dressing were removed and the skin were cleaned of residual test substance using tap water
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- single dosis of 2000 mg/kg (2.27 mL/kg) body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations:
Mortality/Viability: Twice daily
Body weights: Day 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of sosing (day 1) and once daily therafter, until day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture and chromodacryorrhoea were observed in the majority of animals. Lethargy and ptosis were observed in one male. The animals had recovered from the symptoms by day 3. Erythema and scales were seen in the treated skin-area among the females
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examinations of the animals.
Any other information on results incl. tables
Protocol Deviations: Deviations from the maximum level for relative humidity (with a maximum of 20 %) occurred which might have been caused by cleaning procedures in the room. Since there were no indications that the animals were influenced by this deviation, this deviation was considered not to have affected the study integrity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a dermal LD50 of the test substance in Wistar rats was establiehed to exceed 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402, the test substance was administered to five Wistar rats of each sex (females were nulliparous and non-pregnant) by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
No mortality occured. Hunched posture and chromodacryorrhoea were observed in the majority of animals. Lethargy and ptosis were observed in one male. The animals had recovered from the symptoms by day 3. Erythema and scales were seen in the treated skin-area among the females from days 2 to 7. The body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.
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