Registration Dossier
Registration Dossier
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EC number: 219-599-7 | CAS number: 2475-33-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 12, 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The reliability assigned to this study is 4 as the composition of the active ingredient in the test item is low.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965),
- GLP compliance:
- no
Test material
- Reference substance name:
- Vat Brown 001
- IUPAC Name:
- Vat Brown 001
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Porton strain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: average body weights of 2.61 and 2.70
- Housing: rabbits were caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week prior to the start of the trial
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): artificial light for 10 hours daily from 08.00 - 18.00 hours
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 30 sec
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed out of the eyes of three of the rabbits with approximately
200 ml. of warm water.
- Time after start of exposure: 30 sec
SCORING SYSTEM: method described in "Appraisal of the Safety of Chemicals in
Food Drugs and Cosmetics" page 51, published by the Association of
Food and Drug Officials of the U.S.A.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 15, 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 14
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 14, 15, 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 15
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 14, 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 14, 15, 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: washed eyes
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not eye irritant
- Executive summary:
Method
The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), on six healthy Neu Zealand White rabbits.
100 mg of the test compound were instilled into the conjunctival sac of the left eye. The rabbits were examined 1, 24, 48 and 72 hours after application.
Results
Under test conditions the substance result to be not eye irritant
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