Registration Dossier

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Draize method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The anirnals are caged individually and reccive no hay or ether extraneous material that might enter the eyes.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The eye has not been rinsed.
Observation period (in vivo):
The eyes were observed 24 hours, 48 hours, 72 hours and 7 days after instillation of the susbtance
Number of animals or in vitro replicates:
6
Details on study design:
The upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material Scoring with Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
NOTE: Explanation for the concise "BASIS": Six rabbits were tested. ALL animals gave 0 (zero) scores for corneal opacity, iris, conjunctivae, and chemosis after 24 hours and after 48 hours, EXCEPT animal # 1 that had conjunctiva score of 1 after 24 hours only. Therefore individual scores are not entered for each animal for each parameter, and at each time point.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Tert-butyl cumyl peroxide is not irritating to eyes.
Executive summary:

Trigonox T (90 -92% tert-butyl cumyl peroxide) was applied in eyes of 6 rabbits (0.1 mL) in a test conducted according to recognized standards (Draize method). The animals were observed 24 hours and 48 hours after the instillation. The scores for corneal opacity, iritis, conjunctival redness and chemosis were 0, 0, 0.1 and 0, respectively. Therefore the substance is not irritating to eyes.