tert-butyl α,α-dimethylbenzyl peroxide

Eye irritation

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

Test material information

Constituent 1

Reference substance name:

tert-butyl α,α-dimethylbenzyl peroxide

EC Number:

222-389-8

EC Name:

tert-butyl α,α-dimethylbenzyl peroxide

Cas Number:

3457-61-2

Molecular formula:

C13H20O2

IUPAC Name:

[2-(tert-butylperoxy)propan-2-yl]benzene

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 4

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.