Registration Dossier
Registration Dossier
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EC number: 617-745-8 | CAS number: 856976-65-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, no GLP study, please refer to section 13 for justification of read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 82448-02-0
- EC Number:
- 617-334-3
- Cas Number:
- 82448-02-0
- IUPAC Name:
- 82448-02-0
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Male: 3.00 kg, Female: 3.14 kg
- Housing: Housed in fully air-conditioned rooms in cages made of stainless steel with wire mesh walk floors.
- Diet: Kliba 341. 4MM, Firma Klingentalmuehle AG, CH-4303 Kaiserazgst, Switzerland
- Water: About 250 mL Tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
- Bedding: No bedding in the cages; Saw-dust in the waste trays
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Application volume: 0.1 mL
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72h
- Number of animals or in vitro replicates:
- 2 males
1 female - Details on study design:
- APPLICATION
- Single application to the conjunctival sac of the right eyelid
REMOVAL OF TEST SUBSTANCE
- Washing: no washing
SCORING SYSTEM: Scale for scoring ocular lesions:
0 = None
1 = Slight
2 = Well defined
3 = Severe
4 = Very Severe
Calculation of the mean according to 83/467/ EEC criteria of July 29 th, 1989
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: Discharge
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24,48, 72 h
- Score:
- 0
- Max. score:
- 3
Applicant's summary and conclusion
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