Registration Dossier
Registration Dossier
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EC number: 700-205-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20/1/1993
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- Batch Number C2413/173/3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72hours after removal of patch
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- GR101030X produced a Primary Dermal Irritation Index of 0.0 when applied for 4hrs, semi-occlusively to the skin of 3 New Zealand White rabbits. It is considered to be Non-irritating under the conditions of the test.
- Executive summary:
A study was performed to assess the irritatncy potential of GR101030X to the skin of the New Zealand White rabbit. The method used followed that described in OECD No. 404 "Acute Dermal Irritation/Corrosion". A single 4 -hour, semi-occluded applicationto the intact skin of 3 rabbits produced no skin reactions. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.
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