Registration Dossier
Registration Dossier
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EC number: 247-955-1 | CAS number: 26748-41-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-11-09 to 2000-01-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tert-butyl peroxyneodecanoate
- EC Number:
- 247-955-1
- EC Name:
- tert-butyl peroxyneodecanoate
- Cas Number:
- 26748-41-4
- Molecular formula:
- C14H28O3
- IUPAC Name:
- Reaction products of neodecanoic acid (or neodecanoyl chloride derived from neodecanoic acid) and tert-butyl hydroperoxide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, England
- Age at study initiation: at least 6 weeks
- Weight at study initiation: less than 3.5 kg
- Housing: individually housed in labelled cages with perforated floor
- Diet: standar laboratory rabbit diet approx. 100 g per day
- Water: free access to tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 30-70 %
- 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:
- 21 days
- Number of animals:
- 3 animals of one sex
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm
- Type of wrap if used: a metalline patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin cleane of residual test substance using water
- Time after start of exposure: four hours
SCORING SYSTEM: according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- 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 moderate to severe or 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 one animal and within 21 days in the two remaining animals. Reduced flexibility and/or fissuring of the skin, scaliness and bald skin were noted among the animals between 48 hours and termination (after 14 or 21 days).
- Corrosion
There was no evidence of a corrosive effect on the skin. - Other effects:
- - Colouration
On the skin of all animals, sticky remnants of the test substance were present on day 1 and dry remnants were present from day 2 onwards until day 4.
- Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no test substance related mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- 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 the test substance to intact rabbit skin.
- Executive summary:
Tert-butyl peroxyneodecanoate (75 % in solvent) was tested in a primary skin irritation/corrosion study in the rabbit (4 -hour semi-occlusive application) according to EU method B.4 and the OECD guideline no. 404. Three rabbits were exposed to 0.5 mL of the test item, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours and 7, 14 and/or 21 days after exposure.
Exposure to the test item resulted in moderate to severe erythema and moderate to severe oedema in the treated skin-areas of the three rabbits
with mean erythema score of 2.8 and mean edema score of 2.7. The skin irritation had resolved within 14 days after exposure in one animal and within 21 days in the two remaining animals. Reduced flexibility and/or fissuring of the skin, scaliness and bald skin were noted among the animals between 48 hours and termination (after 14 or 21 days). On the skin of all animals, sticky remnants of the test substance were present on day 1 and dry remnants were present from day 2 onwards until day 4.
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 the test substance to intact rabbit skin.
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