Registration Dossier
Registration Dossier
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EC number: 286-185-0 | CAS number: 85187-95-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- December 11 to 19, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
- GLP compliance:
- no
- Remarks:
- Study conducted before 1981
Test material
- Reference substance name:
- Basic Red 018 Acetate - Similar Substance 01
- IUPAC Name:
- Basic Red 018 Acetate - Similar Substance 01
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g of test substance applied as such
- Application: The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male and 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: flushed with 10 ml of physiological saline
- Time after start of exposure: approximately 30 seconds after treatment
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal: 268
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal: 269
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- animal: 270
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 268
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 269, 270
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 268
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 269
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 270
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 268, 269
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 290
- Time point:
- other: mean score following grading at 24, 48, 72 h
- Score:
- ca. 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed eyes
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on CLP criteria
- Conclusions:
- Irreversible effects on the eye
- Executive summary:
Method
The eye irritation was determined in an irritation test according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 405. During the test 3 male and 3 female of Hymalaian rabbit were exposed to the substance as such (3 animals rinsed; 3 animals not rinsed). Approximately 30 seconds after treatment the test item was flushed with 10 ml of physiological saline. The irritation scores were registered after 24, 48, 72 hours, 4 and 7 days and the evaluation of the eye irritatation potential of the test item was conducted considering the mean score following grading at 24, 48 and 72 h for each animal.
Observations
After 7 days the irritation effects were reversible only in one animal (rinsed).
Result
Irreversible effects on the eye.
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