Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

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.