Registration Dossier
Registration Dossier
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EC number: 613-099-6 | CAS number: 62889-66-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study but not GLP compliant, however detailed documentation is available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Batch No.: 87/70046
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler ; 6050 Offenbach/Main Germany
- Weight at study initiation: 2.68 kg (males); 2.47 kg (females)
- Housing: Single in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm X 51 cm
- Diet: KLIBA 341, 4 mm; Klingentalmuehle AG, 4303 Kaiseraugust, Switzerland about 130 g/animal/day
- Water:about 250 ml tap water/animal/day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 15 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: 4 layers of absorbent gauze + porous bandage
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with lutrol and lutrol/water (1:1)
Determination of body weights: Shortly before application (day 0), weekly thereafter and at the end of the study before fasting period.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
Individual readings 30-60 minutes after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study (last day of the observation period).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: Temporarily, effect extending beyond the area of exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: effect extending beyond the area of exposure
- Other effects:
- Scaling was observed in all three animals at day 8 and persisted in animal 3 until day 15. This effect extended beyond the area of exposure on day 8 in animal 3.
Applicant's summary and conclusion
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