Registration Dossier
Registration Dossier
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EC number: 201-222-2 | CAS number: 79-74-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is not performed under GLP conditions, used methods and results are preliminary documented.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rabbits were administered 1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A in corn oil as single oral dose and were observed for 14 days.
- GLP compliance:
- not specified
Test material
- Details on test material:
- Name of test material (as cited in study report): Santovar A
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg, finely ground powder - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72, 120, 168 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72, 120, 168 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 7.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 6.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48, 72, 120, 168 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: FHSA
- Conclusions:
- A study in 6 rabbits suggested that Santovar was slightly to not irritanting for the eye; reversibel (within 48 hours) erythema was described. The study was not performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions and was very poorly documented. Therefore, the information may be considered reliable with major restrictions.
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