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Registration Dossier
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EC number: 228-250-8 | CAS number: 6197-30-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-MAR-24 through 1992-May-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- dilute test substance was also tested
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octocrilene
- EC Number:
- 228-250-8
- EC Name:
- Octocrilene
- Cas Number:
- 6197-30-4
- Molecular formula:
- C24H27NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyano-3,3-diphenylacrylate
- Details on test material:
- - Name of test material (as cited in study report): HR 92/600 154
- Physical state: viscous liquid
- Analytical purity: 98.5%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae, Biberach, Germany
- Weight at study initiation: 2.0 to 2.5 kg
- Housing: singly
- Diet: feed pellets ad libitum
- Water: free access to drinking water, acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 55 +/-15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: ethanol (96%) and diethylphathalate; ratio 1:1 (w/w)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: 1, 10, 25, 50, 100% (w/w)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0 to 0.5 mL
- Concentration: 0 to 99% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: gauze patches were secured with adhesive tape and loosely fixed with Scanpor tape
REMOVAL OF TEST SUBSTANCE
- Washing: with soap and lukewarm water at the end of the 4-hour exposure period
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the table contained in OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritant / corrosive response data:
- No erythema or edema was noted during the study period in any animal with the unchanged or diluted test material.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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