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EC number: 234-042-8 | CAS number: 10508-09-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: GLP, OECD Guideline 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Di-tert-pentyl peroxide
- EC Number:
- 234-042-8
- EC Name:
- Di-tert-pentyl peroxide
- Cas Number:
- 10508-09-5
- Molecular formula:
- C10H22O2
- IUPAC Name:
- 2-methyl-2-[(2-methylbutan-2-yl)peroxy]butane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Adult, New Zealand White rabbits were received at SLS from Myrtle's Rabbitry, Thompson Station, TN.
- Method of Identification: Upon receipt, plastic ear tags displaying unique identification numbers were used to individually identify the animals.
- Housing: The animals were housed individually in suspended stainless steel cages
-Food and water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature : 71 °F
- Humidity (%): 48-67
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.5mL on a clipped area
- Concentration: undiluted - Duration of treatment / exposure:
- 4H
- Observation period:
- 72H
Examination time points: 1h, 24 h, 48 h and 72 hours after the patch removal. - Number of animals:
- 6 males
- Details on study design:
Preliminary Procedures: On day -1, the animals chosen for use on the primary skin irritation study had the fur removed from the dorsal area of the trunk using an animal clipper. Care was taken to avoid abrading the skin during the clipping procedure.
TEST SITE
- Area of exposure: flank - Details:
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with moistened cotton pad.
- Time after start of exposure: 4H
SCORING SYSTEM:
Irritation evaluated for each animal according to the grading scale originally proposed by Draize
Mortality checks were performed twice daily, in the morning and afternoon. lndividual body weights were obtained for each animal prior to dosing on study day O. Gross Necropsy: Each animal was euthanized (intravenous injection of sodium pentobarbital) following its final scoring interval. Gross necropsy examinations were not required for these animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: mean
- Remarks:
- see attached file
- Time point:
- 24/48/72 h
- Score:
- 3.88
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean for the 6 rabbits (5 rabbits with mean erythema score of 4)
- Irritation parameter:
- edema score
- Basis:
- animal: mean
- Remarks:
- see attached file
- Time point:
- 24/48/72 h
- Score:
- 1.15
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean for the 6 rabbits (4 rabbits with mean edema score of 1)
- Irritant / corrosive response data:
- Exposure to the test article produced very slight erythema on 1/6 test sites, mild to severe blanching on 5/6 test sites and very slight to slight edema on 6/6 test sites at the
1 hour scoring interval. The dermal irritation resolved completely in all animals by study
day 14. Additional dermal findings noted during the period included focal/pinpoint to moderate eschar, eschar exfoliation and desquamation, which were noted on 1/6, 1/6 and 6/6 test sites, respectively.
Any other information on results incl. tables
See individual results in the attached tables.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under these experimental conditions, di-tert-amyl peroxide is considered as a skin irritant.
- Executive summary:
The acute dermal irritation of di-tert-amyl peroxide was evaluated in rabbits according to a method similar to OECD 404 guideline. 0.5 ml of the substance was applied undiluted during 4 hours in 6 rabbits on intact or scarified skin (occlusive dressing). The cutaneous reaction was observed 24, 48 and 72 hours after removal of the dressing, and at day 7, 10 and 14.
Exposure to the test article produced very slight erythema on 1/6 test sites, mild to severe blanching on 5/6 test sites and very slight to slight edema on 6/6 test sites at the 1 hour scoring interval. The mean erythema score (over 24, 48 and 72 hours) was 3.88 and the mean edema score was 1.75 (over 24, 48 and 72 hours).The dermal irritation resolved completely in all animals by study
day 14. Additional dermal findings noted during the period included focal/pinpoint to moderate eschar, eschar exfoliation and desquamation, which were noted on 1/6, 1/6 and 6/6 test sites, respectively.
The mena erythema and edema scores over 24, 48 and 72 hours were respectively 3.88 and 1.15.
Under these experimental conditions, di-tert-amyl peroxide is considered as a skin irritant.
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