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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-pentyl peroxypivalate
EC Number:
249-530-6
EC Name:
tert-pentyl peroxypivalate
Cas Number:
29240-17-3
Molecular formula:
C10H20O3
IUPAC Name:
tert-pentyl peroxypivalate
additive 1
Reference substance name:
Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated
EC Number:
297-629-8
EC Name:
Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated
Cas Number:
93685-81-5
Molecular formula:
not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
IUPAC Name:
isododecane
Test material form:
other: clear colorless liquid
Details on test material:
A sample of the test material designated:
tert- amyl peroxypivalate was received from the
principal on June 3, 1981.
The test material, a clear colorles liquid,
was stored at -20 C until use.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
None provided

Test system

Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
One time instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Six
Details on study design:
In general the techniques of tests as published by the FDA of the United States (Fed, Reg, 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 11 (1952) 36) are followed, Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. The eyes of the animals are examined before testing and only those animals without observable eye defects are used. One tenth of a milliliter of the test substance, or in case of solids or semisolids, 100 milligrams of the test substance, is allowed to fall on the everted lower lid of one eye of each rabbit; 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. The other eye, remaining untreated, serves as a control. The eyes are not washed following instillation and the animals are released immediately.
The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material. An animal is considered as giving a positive reaction if there is, at any of the readings, discernible 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 slight 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 eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA-scoring scale is 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. If two or three animals exhibit a positive reaction, the test is repeated, using a different group of six animals. The second test is considered as positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test is again repeated with a different group of six animals. Should a third test be needed the substance will be regarded as an irritant if two or more animals exhibit a positive response. A substance which has elicited corneal and/or iris lesions which have not cleared by the seventh day reading, is considered a severe eye irritant.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Tert-amyl peroxypivalate caused slight redness and/or swelling of the conjunctivae in all animals. After seven days eye irritation was no longer noticeable.

See attached table.

Any other information on results incl. tables

A substance is considered irritating to the eye acoording to CLP when:


If, when applied to the eye of an animal, a substance produces:


- at least in 2 of 3 tested animals, a positive response of:


- corneal opacity ≥ 1 and/or


- iritis ≥ 1, and/or


- conjunctival redness ≥ 2 and/or


- conjunctival oedema (chemosis) ≥ 2


- calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days


 
























Conjunctivae


/score at:



24h



48h



72h



Redness



1



0.5



0.33



Chemosis



0.5



0.16



0.16



* average score (range)


 


Score of 0 for Cornea and Iris.


 


All effects were fully reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained it is concluded that, according to the FDA-standards, tert-ainylperoxypivalate is not considered to be an eye irritant.

It is not classified as an eye irritatiant in accordance with Regulation (EC) No 1272/2008, as amended for the 17th time in Regulation (EU) 2021/849.
Executive summary:

The test article was evaluated for its eye irritation potential following instillation of 0.1 mL into rabbit eyes. The test article caused slight redness and/or swelling of the conjunctivae in all animals After seven days eye irritation was no longer noticeable. Therefore, the test article is not classified as an eye irritant.