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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-07-18 until 1995-07-23
- 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- 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
- Specific details on test material used for the study:
- Stabilizer: hydrocarbon
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: on the day of treatment, the animals had a mean body weight (and standard deviation) of 2.3 (0.1) kg
- Housing: The animals were housed individually in polystyrene cages
- Diet: All the animals had free access to 112 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 (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Photoperiod: 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- A single dose of 0.5 mL of the test substance was applied
- Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 1, 24, 48, 72 hours after application. One animal was observed after 96 hours.
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing (Laboratoires de Pansements et d'Hygiène, 21300 Chenove, France) and a restraining bandage (Laboratoires 3M Santé, 92245 Malakoff, France).
No residual test substance was noted at removal of the dressing.
SCORING SYSTEM:
Erythema and eschar formation:
no erythema...0
very slight erythema (barely perceptible)...1
well-defined erythema...2
moderate to severe erythema...3
severe erythema (beet redness) to slight eschar formation (injuries in depth)...4
Oedema formation:
no oedema...0
very slight oedema (barely perceptible)...1
slight oedema (edges of area well-defined by definite raising)...2
moderate oedema (raised approximately 1 millimetre...3
severe oedema (raised more than 1 millimetre and extending beyond area of exposure)...4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- After a 3-minute application: in one rabbit, very slight erythema (grade 1) was noted on days 2 and 3.
After a 4-hour application: in 2/3 rabbits, very slight erythema (grade 1) was observed for 24 or 48 hours after treatment. In one of these two rabbits, slight oedema (grade 2) was noted only one hour after treatment. In 1/3 animals, very slight to slight erythema (grade 1 or 2) was noted up to 72 hours.
Mean scores over 24, 48 and 72 hours for individual animal were 1.7, 0.7 and 0.3 for erythema, and 0.0 for oedema. - Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study experimental conditions, the test substance was considered non-irritant when administered by cutaneous route in rabbits.
- Executive summary:
The potential of the test substance to induce dermal irritation was evaluated in rabbits according to the OECD 404 and EU method B4 guidelines. The test substance was applied in a first assay for a period of 3 minutes and 4 hours in one male New Zealand White rabbit.
Since the test substance was not strongly irritant in this first assay, it was applied for 4 hours in two other males in a second assay. A single dose of 0.5 mL of the test substance was applied to the closely-clipped skin of the flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately one hour, 24, 48 and 72 hours after removal of the dressing and then at 96 hours only for one rabbit.
Very slight to slight erythema was observed in the three animals until day 2, 3 or 4, respectively. In one rabbit, slight oedema was noted only one hour after treatment. Mean scores over 24, 48 and 72 hours for individual animal were 1.7, 0.7 and 0.3 for erythema and 0.0 for oedema.
Under our experimental conditions, the test substance was considered non-irritant when administered by cutaneous route in rabbits.
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