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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:
1996
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:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
All housing and care were based on the standars recommended by the Guide for the Care and Use of Laboratory Animals.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide
EC Number:
213-944-5
EC Name:
Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide
Cas Number:
1068-27-5
Molecular formula:
C16H30O4
IUPAC Name:
2,5-bis(tert-butylperoxy)-2,5-dimethylhex-3-yne
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Adult, New Zealand White rabbits were received at SLI from Myrtle's Rabbitry, Thompson Station, TN.
- Animal Selection: The animals for study were arbitrarily selected from healthy stock animals to avoid potential bias. All animals received a detailed pretest observation prior to dosing. Only healthy animals were chosen for study use. Females were nulliparous and nonpregnant.
- Housing: The animals were housed individually in suspended stainless steel cages.
- Identification: Plastic ear tags displaying unique identification numbers were used to individually identify the animals.
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study. the purified water was supplied by an automatic watering system.
- Acclimation period: Animals were acclimated for a minimum of five days to the laboratory conditions. The animals were observed daily for overt physical or behavioral abnormalities, general health/moribundity and mortality.

ENVIRONMENTAL CONDITIONS
- Temperature: ca. 16.7 - 18.9 °C
- Humidity: 52 - 64 %:
- Air changes: 10 - 15 per hour
- Photoperiod: 12-hour light/12-hour dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye, remaining untreated, serves as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 100 %
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
1, 24, 48 and 72 hours after dosing
Number of animals or in vitro replicates:
6 (2 males, 4 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: At the 24 hour scoring interval, any residual test acticle was gently rinsed from the eye at this time using physiological saline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, the test substance is considered to be a non irritant to the ocular tissue of the rabbit.
Executive summary:

In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the eyes of New Zealand White rabbits. Each of six rabbits received a 0.1 mL dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing. Exposure of the test article produced conjunctivitis (redness and/or swelling and/or discharge) in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the 72 hour scoring interval. A mean conjunctivae score (24,48,72h) of 0.4 was determined. The observed mean scores for cornea, iris and chemosis were 0. Under the conditions of this test, the test substance is considered to be a non irritant to the ocular tissue of the rabbit.