Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June to April 1999
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Information removed from report
- Age at study initiation: minimum 12 weeks
- Weight at study initiation: 2489 to 2671 g
- Housing: Individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 -23
- Humidity (%): 33-56
- Air changes (per hr):minimum 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- Single dose, 4 hour exposure
- Observation period:
- The treated skin was examined on Day 1 and on days 2, 3 and 4 (24, 48 and 72 hours after removal of the dressings) and additional observations made on days 5 through 14 for all animals.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorso lumbar region
- % coverage: 10
- Type of wrap if used: porous gauze pad was covered with semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The single application of test material elicited a persistent well-defined dermal irritation in all animals with resolution complete by Day 14. The irritant response was associated with desquamation of the stratum corneum (characterised with dryness and sloughing) notable in all animals with skin thickening in two animals during the observation period with desquamation still evident at study termination. The primary irritation index was calculated to be 4.1.
- Other effects:
- No deaths occurred during the study. There was no evidence of systemic toxicity to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In the skin irritation study, conducted according to OECD 404 and in compliance with GLP, the test material elicited well-defined persistent dermal irritation in rabbits; although, the irritancy score did not meet the criteria for irritation. However, desquamation evident in two test animals at study termination on Day 14 indicates that the test material is a skin irritant (Category 2).
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