Registration Dossier
Registration Dossier
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EC number: 619-636-0 | CAS number: 125971-57-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-03-03 to 1997-09-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to 92/69/ECC (Acute toxicity; skin irritation) under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): PD 132408
- Substance type: Lumpy white powder
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Eastfield, Sussex, England
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2.3 to 2.8 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes but not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21 °C
- Humidity (%): 52-73 %
- Air changes (per hr): 19 airchanges per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours after exposure
time points 60 min, 24 h, 48 h, 72h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorso lumbar region
- % coverage: 25 mm x 25 mm
- Type of wrap if used: Elastoplast
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation:
No erythema (barely perceptible) = 0
Very slight erythema = 1
Well-defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythma reading = 4
Oedema formation:
No Oedema = 0
Very slight Oedema (barely perceptible) = 1
Slight Oedema (edges of area well-defined by definite raising) = 2
Moderate to severe Oedema (raised approximately 1 millimetre) = 3
Severe Oedema (raised more than 1 millimetre and extending beyond the area of exposure) = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No dermal reaction to treatment was observed in any animal throughout the study
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of PD 132408 to intact rabbit skin for four hours elicited no dermal irritation
- Executive summary:
A study was performed to assess the skin irritation potential of PD 132408 to the rabbit. The method followed was that described in ECC Methods for the determination of toxicity. The rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal reactions were observed in any animal following a single semi-occlusive application of PD 132408 to intact rabbit skin for four hours.
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