Registration Dossier
Registration Dossier
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EC number: 271-846-8 | CAS number: 68609-97-2
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: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- The study was conducted according to the method outlined by Draize et al.
- GLP compliance:
- no
Test material
- Details on test material:
- Epoxide No. 8
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
no details given
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4.08
- Reversibility:
- no data
- Remarks on result:
- probability of moderate irritation
- Remarks:
- Cumulative scores and mean values provided
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Primary Irritation Index = 4.08
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
- Conclusions:
- Undiluted Epoxide No. 8 produced moderate primary irritation upon prolonged exposure to rabbits' skin by closed patch technique.
- Executive summary:
Three New Zealand Albino rabbits per group, were treated with 0.5ml of Epoxide 8, applied to a 1" x I" l2-ply gauze pad. The pads were taped on both an intact and abraded site on each animal.. The narrow adhesive tape was crossed in an ‘X’ to hold the gauze pad but not to occlude the ventilation.
After 24 hours, the animals were removed from the stocks, patches were removed and the resulting-reactions evaluated on the basis of scores indicated by Draize. The cumulative scores (24 and 72 hours; abraded and intact) are averaged separately for both erythema and edema and are then added together to arrive at a Primary Irritation Index.
Undiluted Epoxide No. 8 produced moderate primary irritation (PII = 4.08) upon prolonged exposure to rabbits' skin by closed patch technique.
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