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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study under GLP with acceptable restrictions in documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: The test item was dissolved in diethylphtalate, concentration: 5-20%
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : tert-Butyl-4-methoxy-4'dibenzylmethane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: diethylphtalate
Controls:
not required
Amount / concentration applied:
0.1 mL of a solution containing 5%, 10% and 20% BMDBM.
Duration of treatment / exposure:
Single application of a 5%, 10% and 20% solution each
Observation period (in vivo):
After 1, 24, 48, and 72h. Post-observation after 7 and 14 days.
Number of animals or in vitro replicates:
Three animals per dose group.
Details on study design:
SCORING SYSTEM: Draize system
Corneal opacity: 0-4
Iris: 0-2
Conjunctival redness: 0-3
Conjunctival swelling (chemosis): 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 5% solution
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 5% solution
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: 5% solution
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 5% solution
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 10% solution
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 2-3d
Remarks on result:
other: 10% solution
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 10% solution
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20% solution
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 20% solution
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3d
Remarks on result:
other: 20% solution
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20% solution
Irritant / corrosive response data:
As given above.Single application of a 5-20% solution of BMDBM in diethylphtalate caused weak shortlasting conjuncticval irritation of the rabbit eye. No alteration of the cornea was observed macroscopically.
Other effects:
No further effects were reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 20% solution of butyl methoxydibenzoylmethane (BMDBM) dissolved in diethylphtalate caused weak shortlasting conjunctival irritation of the rabbit eye. No alterations of the cornea was observed macroscopically.
Therefore, BMDBM can be considered as non-irritant to the eye and no classification according to EU CLP is needed.
Executive summary:

The determination of eye irritating effects of butyl methoxydibenzoylmethane (BMDBM) was performed in a study similar to OECD Guideline 405 on three rabbits: BMDBM as 5%, 10%, and 20% solution in diethylphtalate was placed in the conjunctival sac of one rabbit eye and the effects are recorded after 1h, 24h, 48h, 72h, 7 days and 14 days. Observations comprised opacity of the cornea, iris reaction, conjunctival redness and swelling (chemosis).

The instillation of a solution of BMDBM caused concentration-dependent weak conjunctival irritation of the rabbit eye which was fully reversible within up to 3 days. The mean irritation scores for the 20% solution (3 animals, 24 - 72h after administration) were 0 (Cornea opacity), 0 (Iris), 0.67 (Conjunctivae redness), 0 (Chemosis).

Therefore, BMDBM can be considered as non-irritant to the eye and no classification according to EU CLP is needed.