Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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: Comparable to guideline study with acceptable restrictions (no 1-h reading; 6 animals, thereof 3 rinsed after 30s)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no 1-h reading; 6 animals, thereof 3 rinsed after 30s)
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): FAT 66’031/A
- Analytical purity: > 80%
- Physical state: solid (powder)
- Lot/batch No.: Op. 1/81
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS GmbH, Med. Versuchstierzuchten KG, D-7964 Kisslegg.
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet: standard rabbit food (NAFAG, No. 814, Gossau SG); ad libitum
- Water: water; ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required; the other eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- one single exposure
The eyes of 3 animals were rinsed after 30 s; the eyes of the other 3 animals were not rinsed - Observation period (in vivo):
- 7 days
Reading time points at 24, 48 and 72 h and 4 and 7 days after instillation. - Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- Only rabbits with normal ophthalmic findings were used in this test.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the treated eye of 3 rabbits was flushed with 10 mL physiological saline 30 seconds after instillation.
SCORING SYSTEM: Scoring was performed according to the Draize Scoring System.
TOOL USED TO ASSESS SCORE: slit-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: not rinsed; slight discharge (score = 1) at 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of animal #2 and #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: not rinsed
- Irritant / corrosive response data:
- Conjunctival redness (grade 2 and 1) developed in 2 animals (not rinsed and rinsed, respectively), and discharge in 1 animal (not rinsed) was observed. These changes were apparent 1 day after instillation, but not thereafter. Only the results of animals that were not rinsed were taken into account for evaluation.
- Other effects:
- One animal died 7 days after instillation of the test material and it was stated that no symptoms had been observed prior to death.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa.
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