Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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
Principles of method if other than guideline:
NA
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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-tris(methylperoxy)hexanoate

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
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.