Registration Dossier
Registration Dossier
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EC number: 211-185-4 | CAS number: 632-79-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 11-14, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to accepted guideline and Good Laboratory Practices.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- review article or handbook
- Title:
- Appraisal of the safety of chemicals in foods, drugs and cosmetics - dermal toxicity; pg 49-52
- Author:
- Draize J
- Year:
- 1 965
- Bibliographic source:
- Association of Food and Drug Officials of the U.S., Topeka, KS
- Reference Type:
- review article or handbook
- Title:
- Appraisal of chemicals in foods, drugs, and cosmetics; pg 36-45
- Author:
- Draize J
- Year:
- 1 959
- Bibliographic source:
- Association of Food and Drug Officials of the U.S., Austin, TX
- Reference Type:
- publication
- Title:
- See Table 1
- Author:
- Draize, J et al.
- Year:
- 1 944
- Bibliographic source:
- J. Pharm. Exp. Ther. 82:377-390
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 560/6-82-001
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrabromophthalic anhydride
- EC Number:
- 211-185-4
- EC Name:
- Tetrabromophthalic anhydride
- Cas Number:
- 632-79-1
- Molecular formula:
- C8Br4O3
- IUPAC Name:
- tetrabromo-1,3-dihydro-2-benzofuran-1,3-dione
- Details on test material:
- The test material was the commercial Saytex RB-49 product.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Adult male and female rabbits were obtained from Sgarlat's Rabbitry, Harvey's Lake, PA. Housed individually in temperature and humidity contolled room with a 12/12 hr light/dark cycle. Wayne Rabbit Ration and water were provided ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal (left eye) served as its own control
- Amount / concentration applied:
- One application of 100 mg to the right eye.
- Duration of treatment / exposure:
- 72 hrs
- Observation period (in vivo):
- 1, 24, 48, 72 hours.
- Number of animals or in vitro replicates:
- 3 M and 3 F
- Details on study design:
- Animals were examined 24 hr prior to dosing. Any showing eye irritation/damage were not utilized in the study. The test substance was placed in the conjunctival sac of the right eye of each animal. The lids were gently held together for 1 second to limit loss of the material. The left eye served at the control.
Grading was according to the method of Draize 1965, Draize 1959, and Draize et al. 1944.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 hr post-dosing
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4/6 rabbits had scores of 1 at 1 hr post-dosing
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1/6 rabbits had score of 1 at 24 hr post-dosing
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Saytex RB-49 was not an eye irritant.
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