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Toxicological information

Eye irritation

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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:
1986
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:
1965
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:
1959
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:
1944
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

Constituent 1
Chemical structure
Reference substance name:
Tetrabromophthalic anhydride
EC Number:
211-185-4
EC Name:
Tetrabromophthalic anhydride
Cas Number:
632-79-1
Molecular formula:
C8Br4O3
IUPAC Name:
tetrabromophthalic anhydride
Details on test material:
The test material was the commercial Saytex RB-49 product.

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:
other: all scores at all time points were 0
Time point:
other: 1, 24, 48 and 72 post-dosing
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: all scores at all time points were 0
Time point:
other: 1, 24, 48, and 72 hr post-dosing
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:
other: 24 hr post-dosing
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:
other: all scores at all timepoints = 0
Time point:
other: 1, 24, 48, 72 hr
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.