Registration Dossier
Registration Dossier
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EC number: 700-205-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30/3/1993
- Reliability:
- 1 (reliable without restriction)
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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Observation period (in vivo):
- 1, 3, 6 ,24 ,48 and 72hours after treatment
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 3, 7, 24, 48, 72h
- Score:
- ca. 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 maximum overall mean score of 0.0 and was classified as non-irritant to the rabbit eye
- Executive summary:
A study was performed to assess the irritancy potential of GR101030X following a single application (10mg) to the eye of the New Zealand White rabbit. The method was based on the method described in OECD guidelines for Testing of Chemicals (1987) no. 405 "Acute Eye Irritation/Corrosion" . A single application of GR101030X to the non-irrigated eye of three rabbits produced no ocular reactions. The test material produced a maximum overall mean score of 0.0 and was classified as non-irritant (grade 0) to the rabbit eye.
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