Registration Dossier
Registration Dossier
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EC number: 207-293-6 | CAS number: 459-57-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
- Specific details on test material used for the study:
- Purity 98.7 % [GC a/a]
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.6 - 3.7 kg
- Housing: individually
- Diet: Altromin 2123 ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 55 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of test animal
- Amount / concentration applied:
- 0.1 ml undiluted
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were inspected for integrity 24 hours before the testing. A solution of fluorescein, sodium salt (0.01%) was dropped into the eye. Then the cornea was investigated using UV radiation.
24 hours after instillation eyes were rinsed with physiological saline.
24 hours, 72 hours and 7 days after application eyes were examined for integrity in the same manner as prior to the testing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 163
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 173
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal: 163
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal: 173
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 163
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 173
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 163
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 173
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions the test item revealed irritating effects meeting the GHS criteria for category 2, H319 irritating to eyes.
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