Registration Dossier
Registration Dossier
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EC number: 701-162-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-03-05 to 1991-03-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; well-performed and well-documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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:
- 6-[3-(C12-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
- EC Number:
- 701-162-1
- Molecular formula:
- C22H37NO4 - C28H49NO4
- IUPAC Name:
- 6-[3-(C12-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin irritation potential ot the registration substance was investigated according to the OECD Guideline 404. The registration substance is not skin irritating.
- Executive summary:
The skin irritation potential ot the registration substance was investigated according to the OECD Guideline 404. Erythema of up to scoring of 2 was found within three days after treatment, which was reversible within 7 days.
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