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EC number: 222-321-7 | CAS number: 3425-61-4
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- 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:
- tert-pentyl hydroperoxide
- EC Number:
- 222-321-7
- EC Name:
- tert-pentyl hydroperoxide
- Cas Number:
- 3425-61-4
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-methylbutane-2-peroxol
- Test material form:
- other: liquid
- Details on test material:
- . description: colourless liquid
. container: one plastic flask
. date of receipt: 7 April 1998
. storage conditions: at room temperature and protected from light
. expiry date: September 1998.
. The pH of the test substance, measured at CIT, was approximately 3.
. Purity : 87.6 %, in water
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals:
Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number and identification: one animal was used. The animal was identified with a metal tag in the ear.
Weight: on the day of treatment, the animal had a body weight of 2.4 kg.
Acclimatization: at least 5 days before the beginning of the study.
Environmental conditions:
The animal was housed in a polystyrene cage (35 cm x 55 cm x 32 cm or 48.2 cm x 58 cm x 36.5 cm) equipped with a food container and a water bottle
. temperature: 18 ± 3°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
. Food and water were provided at libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing, and then daily until day 9.
- Number of animals:
- 1
- Details on study design:
- Doses of 0.5 ml of the test substance were placed on a 6 cm2 dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animal.
As possible irritant effects were anticipated, the test substance was evaluated in one animal in a first assay. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
The animal was killed on day 9 for ethical reasons.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean erythema score after a 3-min exposure
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Black coloration and thickening of the skin from day 5.
- Irritation parameter:
- other: mean oedema score after a 3-min exposure
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: score masked by thickening of the skin from D5
- Irritation parameter:
- other: mean erythema scores after a 4 hour-exposure
- Basis:
- animal #1
- Time point:
- other: 24h, 48 h and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- 9 days (the animal was sacrified at day 9 for ethical reasons)
- Remarks on result:
- other: necrosis until day 9, then tissue destruction
- Irritation parameter:
- other: mean oedema scores after a 4 hour-exposure
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- scoring masked by necrosis from D5
- Irritant / corrosive response data:
- After a 3-minute exposure: A well-defined or moderate erythema (grade 2 or 3) was observed between day 1 and day 5 and
a slight oedema (grade 2) was noted between day 1 and day 4. A thickening and a black colouration of the skin were noted from day 5.
After a 4-hour exposure: A severe erythema (grade 4) and a slight or severe oedema (grade 2 or 4) were observed from day 1. Signs of necrosis were observed from day 2; they have masked the evaluation of cutaneous reactions from day 5. A tissular destruction was recorded on day 9. - Other effects:
- No other effects.
The animal was killed on day 9 for ethical reasons.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Under the experimental conditions, tert-amyl hydroperoxide is corrosive when applied topically to rabbits for 4 hours.
- Executive summary:
The potential of the test substance LUPEROX TAH 85 to induce skin irritation was evaluated in rabbits according to OECD guideline no. 404 and GLP. The test substance was applied for periods of 3 minutes and 4 hours to one male New Zealand White rabbit. A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of each flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until day 9. The mean values of the scores for erythema and oedema were calculated.
After a 3-minute exposure, a well-defined or moderate erythema was observed between day 1 and day 5 and a slight oedema was noted between day 1 and day 4. A thickening and a black colouration of the skin were noted from day 5. After a 4-hour exposure, a severe erythema and a slight or severe oedema were observed from day 1. Signs of necrosis were observed from day 2; they have masked the evaluation of cutaneous reactions from day 5. A tissular destruction was recorded on day 9.
The animal was killed on day 9 for ethical reasons. LUPEROX TAH 85 is corrosive when applied topically to rabbits for 4 hours.
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