Registration Dossier
Registration Dossier
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EC number: 451-540-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - 3 male rabbits used – 1 treated group
- Age/Bodyweight at start: 2 to 4 month-old; 2.9 +/-0.2kg
- Temperature: 18+/-3°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 1 rabbit/cage
- Food and water ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g/flank, i.e. 1g/rabbit
- Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 72 hours (scoring at 1, 24, 48, 72 hours) after the patch removal
- Number of animals:
- 3
- Details on study design:
- Preparation of test site
- application on both clipped flanks
- exposure of 3min on one flank and 4h on the other flank
- test item held in contact with the skin by a gauze pad and hypoallergenic aerated semi-occlusive adhesive dressing
Vehicle
none; purified water used for moistening of the test item at application sites
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hour for erthema and oedema, at all time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: for erythema and oedema, at all time points
- Irritant / corrosive response data:
- Thiofestermet is non irritant when applied topically to rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Thiofestermet is non irritant when applied topically to rabbits.
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