Registration Dossier
Registration Dossier
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EC number: 432-500-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28-07 to 31-07-1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Castor Oil/Maleic Anhydride Adduct CAS# 10502-43-12
- Date received: 16 June 1998
- Description: clear yellow liquid
- Specific gravity: 1.03
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace animals, Boyertown, PA on 7/7/1998
- Quarantine period of at least one week.
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.2 - 2.5 kg
- Fasting period before study: not applied
- Housing: 1/cage
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5321)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 to 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- At 30 and 60 minutes after removal and cleaning, therafter at 24, 48 and 72 h.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Day prior to application of the test article, dorsal area of 10 x 15 cm of each animal was clipped free of hair.
- Coverage: four layer surgical gauze patch 2.5 x 2.5 cm
- Type of wrap if used: plastic wrap with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle with destilled water
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0 - 72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0 - 72 h
- Score:
- 0.28
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.83
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- At 1 hour grade 1 erythema was observed in 2 animals, and grade 2 erythema was observed in 1 animal. Grade 1 edema was observed in 1 animal at this time point.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classified as skin irritation (for Category 2 at least 4 out of 6 rabbits should show a mean score per animal of ≥ 2.3 ≤ 4.0 for erythema/eschar or for edema).
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