Registration Dossier
Registration Dossier
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EC number: 432-690-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Analogue substance tested; GLP study using standard method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: D. Percival, Moston, Cheshire, UK
- Age at study initiation:12 - 16 weeks
- Weight at study initiation: 2,68 -3,08 kg
- Housing: individual
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: > 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -21 C
- Humidity (%): 62 -65 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL = ca 81 mg - Duration of treatment / exposure:
- 4 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Annex VI of 67/548 EG
TOOL USED TO ASSESS SCORE: none
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- > 0.3 - < 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- > 0.3 - < 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: < 48 h
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Residual test material was noted in all treated eyes at the
1-hour observation and in two treated eyes at the 24-hour
observation and one treated eye at the 48-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- An analogue substance produced only mild transient effects on the eyes of rabbits. The substance is not expected to cause significant eye irritation.
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