tert-butyl 3,5,5-trimethylperoxyhexanoate

Eye irritation

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:

comparable to guideline study with acceptable restrictions

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl 3,5,5-trimethylperoxyhexanoate

EC Number:

236-050-7

EC Name:

tert-butyl 3,5,5-trimethylperoxyhexanoate

Cas Number:

13122-18-4

Molecular formula:

C13H26O3

IUPAC Name:

tert-butyl 3,5,5-trimethylhexaneperoxoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Housing: The animals are caged individually and receive no hay or other extraneous material that might enter the eyes.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: One tenth of a mL of the test substance is allowed to fall on the averted lower lid of one eye of each rabbit.

Duration of treatment / exposure:

one application

Observation period (in vivo):

24, 48, 72 hours and 7 days after installation of the test material

Number of animals or in vitro replicates:

6

Details on study design:

The eyes are not washed following installation and the animals are released immediately.

SCORING SYSTEM: The response is positive if, at any of the readings, discernable opacity of the cornea (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a deepening of the folds (rugae) or a slight circumcorneal injection), or if such substances produce in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with partial reversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernable. The FDA-scoring scale was used. The test is considered positive if four or more of the animals in the test group of six rabbits exhibit a positive reaction. If one animal exhibits a positive reaction, the test is regarded as negative.

TOOL USED TO ASSESS SCORE: Ocular reactions are read using a binocular magnifying glass. The diagnosis of corneal damage is confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Other effects:

The ocular effects Trigonox 42 S were as follows:
slight redness of the conjunctivae in one out of six rabbits

Any other information on results incl. tables

Individual scores awarded to the ocular lesions elicited by Trigonox 42 S:

rabbit	cornea	iris	conjunctivae
			redness	chemosis
after 24 hours
9	0	0	1	0
10	0	0	0	0
11	0	0	0	0
12	0	0	0	0
13	0	0	0	0
14	0	0	0	0
after 48 hours
9	0	0	1	0
10	0	0	0	0
11	0	0	0	0
12	0	0	0	0
13	0	0	0	0
14	0	0	0	0
after 72 hours
9	0	0	0	0
10	0	0	0	0
11	0	0	0	0
12	0	0	0	0
13	0	0	0	0
14	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The present eye irritation test showed that, according to the FDA-standards, tert-Butylperoxy-3,5,5-trimethylhexanoat is not considered to be eye irritant.

Executive summary:

Tert-Butylperoxy-3,5,5-trimethylhexanoat was tested to six New Zealand White albino rabbits. In general the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelly (Drug Cosmet. Industr. 71 (1952) 36) for eye irritation test are followed.

Six New Zealand White albino rabbits are used. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. One tenth of a mL of the test substance is allowed to fall on the averted lower lid of one eye of each rabbit; the upper and lower eye lid is then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, served as a control. The eyes are examined at 24, 48, 72 hours and 7 days after installation of the test material.

Tert-Butylperoxy-3,5,5-trimethylhexanoat caused minimal lesions in one out of six rabbits. The present eye irritation test showed that, according to the FDA-standards, tert-Butylperoxy-3,5,5-trimethylhexanoat is not considered to be eye irritant.