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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2a Guideline study without detailed documentations (no certificat of analysis for example)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: CFR 1500
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-pentyl 2-ethylperoxyhexanoate
EC Number:
211-687-3
EC Name:
tert-pentyl 2-ethylperoxyhexanoate
Cas Number:
686-31-7
Molecular formula:
C13H26O3
IUPAC Name:
2-methylbutan-2-yl 2-ethylhexaneperoxoate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): tert-amyl peroxyoctoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: purchased from H.A.R.E. - Rabbits for Research, Hewitt, N.J. for use in this study.
- Age at study initiation: no data
- Weight at study initiation: 2-4 kg
- Housing :individually in wire mesh bottom cages in an environment-controlled room.
- Diet and water : ad libitum
- Acclimation period: quarantined for a minimum of 5 day

ENVIRONMENTAL CONDITIONS
All housing and care conformed to the sta'ndards established in "Guide for the Care and use of Laboratory Animals" DHEW publication
No. (NIH) 78-23.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Prior to the test, the eyes were examined with sodium fluorescein and an ultraviolet lamp. only animals without any lesion were used for the test.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under these experimental conditions, tert-amyl peroxyoctoacte is not irritating for rabbit eye.
Executive summary:

The potential of tert-amyl peroxyoctoacte to induce ocular irritation was evaluated in rabbits according to CFR 1500 guideline and in compliance with GLP.

A single dose of 0.1mL of the undiluted test item was administered to one eye of six New Zealand White Rabbits.

. The other eye was not treated and served as control.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

Mean scores for all animals over 24, 48 and 72 hours were 0 for chemosis, redness of the conjunctiva, iris lesions and for corneal opacity.

Under these experimental conditions, tert-amyl peroxyoctoacte is not irritating for rabbit eye.