Registration Dossier
Registration Dossier
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EC number: 285-549-6 | CAS number: 85116-96-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted accorrding to OECD protocol and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C10-20-neo-
- EC Number:
- 285-549-6
- EC Name:
- Fatty acids, C10-20-neo-
- Cas Number:
- 85116-96-7
- Molecular formula:
- C10H20O2 ... C20H40O2
- IUPAC Name:
- C10-20-neo-Fatty acids
- Details on test material:
- - Name of test material (as cited in study report): Versatic 1019
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The rabbits were housed individually in aluminium cages (dimensions 48 x 61 x 46 cm) with grid floors beneath were absorbent paper lined trays.
Mean environmental maximum and minimum temperatures during the study period were 21 C and 19 C and mean relative humidity was 46%. A 12 h light/dark cycle was in operation (light hours 0700-1900 h), with 15-20 air changes per hour.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Assumed 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Daily for 8 days.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: between shoulders and hindquarters
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours and 4 days
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour, 6 and 8 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours, 4, 6 and 8 days
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Mild and transient erythema was observed in 2 of 3 animals.
- Executive summary:
In this study 3 male rabbits were exposed via semioccluded patch for 4 hours to 0.5 g of Versatic 1019 to assess the irritation potential. Mild and transient erythema was noted in 2 of 3 animals. All reactions were fully reversible within 6 days post exposure.
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