Registration Dossier
Registration Dossier
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EC number: 240-385-4 | CAS number: 16294-75-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: early study; no GLP; poor sample characterisation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- reduced observation period (24h)
- GLP compliance:
- no
- Remarks:
- predates GLP
Test material
- Reference substance name:
- Fluoreszenzrot GG
- IUPAC Name:
- Fluoreszenzrot GG
- Details on test material:
- no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Yellow Silver
Test system
- Vehicle:
- other: sesame oil
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 h; no washing reported
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 5
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1-3-7-24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: visual inspection, no scores reported; as there were no signs of irritation the score was set at 0
- Irritant / corrosive response data:
- no irritation
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritant to the eyes of rabbits
- Executive summary:
Eyes of five rabbits were exposed to 0.5 ml each of 5 and 10 % solutions of the test material. Effects were checked at 1, 3, 7 , and 24 hours after instillation.
No signs of irritation were detected at any time point.
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