Registration Dossier
Registration Dossier
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EC number: 213-147-2 | CAS number: 927-07-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-10-20 to 1998-11-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 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 peroxypivalate
- EC Number:
- 213-147-2
- EC Name:
- tert-butyl peroxypivalate
- Cas Number:
- 927-07-1
- Molecular formula:
- C9H18O3
- IUPAC Name:
- tert-butyl 2,2-dimethylpropaneperoxoate
- 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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 1260-1650 g
- Housing: individually housed in labelled cages with perforated floors
- Diet: standard laboratory rabbit diet; approx. 100 g per day
- Water: Free access to tap-waterdiluted with decalcified water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50 %
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours and 7 and 14 days
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 square centimeters
- Type of wrap if used: Metalline patch
REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was removed and the remaining test item removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to guidelines
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- no. 1379
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- no.1383
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- no. 1384
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- no. 1379
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- no. 1383
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- no.1384
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Irritation:
Four hours exposure to 0.5 mL of the test item resulted in well defined or moderate to severe erythema and moderate to severe oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 14 days after exposure in all animals. Reduced flexibility of the skin was present in one animal after 72 hours. Bald skin at the edges of the application-area and/or scaliness were observed among the animals between 7 and 14 days after exposure.
Corrosion:
There was no evidence of a corrosive effect o the skin. - Other effects:
- Colouration:
No staining of the treated skin by the test item was observed.
Toxicity/Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In an in vivo skin irritation study with rabbits, TBPPI was shown to be irritating to the skin.
- Executive summary:
Primary skin irritaton/corrosion study with tert-butyl peroxypivalate in rabbit (4 -hour semi-occlusive application) according to EU method B.4 and OECD guideline no. 404. Three rabbits were exposed to 0.5 mL of tert-butyl peroxypivalate, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Obersations were made 1, 24, 48 and 72 hours and 7 and 14 days after exposure.
Exposure to tert-butyl peroxypivalate resulted in well defined or moderate to severe erythema and moderate or severe oedema in the treated skin-aeras of the three rabbits with mean erythema score of 2.3 and mean edema score of 2.7.
The skin irritation had resolved within 14 days after exposure in all animals. Reduced flexibility of the skin was present in one animal after 72 hours. Bald skin at the edges of the application-area and/or scaliness were observed among the animals between 7 and 14 days after exposure.
No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occured by dermal application of tert-butyl peroxypivalate to intact rabbit skin. Thus, the substance was evaluated to be skin irritating.
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