Registration Dossier
Registration Dossier
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EC number: 600-715-3 | CAS number: 106092-09-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.03.1995 to 21.03.1995
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- checked and confirmed
- IUPAC Name:
- checked and confirmed
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- One time treatment
- Observation period (in vivo):
- Up to 14 days
- Number of animals or in vitro replicates:
- 1 male and 1 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: rinsed with water after application
- Irritant / corrosive response data:
- The treated unrinsed eye showed markedly deepened rugae of the iris from 2nd to 4th day post administration, as well as a moderate conjunctival reddening and slight chemosis 1 h to 7 days post administration.
In the treasted rinsed eye, the alterations were less severe, so that rinsing with water after an accidental ocular contamination is recommended.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Substance is irritating the eyes.
- Executive summary:
The results of this test indicate that severe alterations are to be expected if rabbit eyes were treated with 100 mg of the compound corresponding to OECD Guideline No 405. Therefor, in accordance with the USA - Interagency Regulatory Liason Group Guideline, no further test is considered necessary.
The phrase "irritant to eyes" is recommended on the basis of the results obtained in this test.
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