Registration Dossier
Registration Dossier
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EC number: 604-075-6 | CAS number: 138401-24-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March 1994 to 28 March 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidelines for testing of chemicals and with regulatoy texts published in the french "Journal Officiel" on 1 February 1982; 9 June 1992 and 5 April 1971
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- GLP compliance:
- yes
Test material
- Reference substance name:
- SR 47563
- IUPAC Name:
- SR 47563
- Details on test material:
- - Name of test material (as cited in study report): SR 47563
- Physical state: powder
- Lot/batch No.: 3SNP022
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand hybrid
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Les Dombes, Romans, 01400 Chatillons sur Chalaronnes, France
- Age at study initiation: 6 weeks old approximately
- weight : 2.5 kg
- Diet: ad libitum
- Water: free access
- Acclimation period: 2 weeks
- Housing: singly in wire mesh bottom, stainless steel cages. The space allocated 0.30 m2 x 39 cm
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 50-85%
- Air changes (per hr): 10-11 per hour without recirculation
- Photoperiod (hrs dark / hrs light): 12/24 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1h (D3), 24h (D4), 48h (D5), 72h (D6)
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- other: maximal primary ocular irritation index
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Modified Kay and Calendra method.
- Conclusions:
- The test material is slighlty irritant to the eyes.
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