Di-tert-pentyl peroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a, Eq to OECD Guideline 405, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Di-tert-pentyl peroxide

EC Number:

234-042-8

EC Name:

Di-tert-pentyl peroxide

Cas Number:

10508-09-5

Molecular formula:

C10H22O2

IUPAC Name:

2-methyl-2-[(2-methylbutan-2-yl)peroxy]butane

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 SLS from Myrtle's Rabbitry, Thompson Station, TN.
- Upon receipt, plastic ear tags displaying unique identification numbers were used to individually identify the animais. Cage cards displaying at least the study number, animal number and sex were affixed to each cage.
- Age at study initiation: no data. Adults animals were used
- Weight at study initiation: 2.65-3.01kg
- Housing: The animals were housed individually in suspended stainless steel cages.
- Diet and water: ad libitum
- Quarantine period: 5days


ENVIRONMENTAL CONDITIONS
- Temperature: 71-73°F
- Humidity : 57-72%
- Air changes (per hr): approx. 12
- Photoperiod : 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

- Amount applied : 0.1mL

Duration of treatment / exposure:

24 h then rinced

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: all

Remarks:

see attached file

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal: mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under these experimental conditions, the test item di-tert-amyl peroxide was not irritant when administered by ocular route to rabbits.

Executive summary:

The potential of di-tert-amyl peroxide to induce ocular irritation was evaluated in rabbits according to a method similar to OECD 405 guideline.

A single dose of 0.1mL of the undiluted test item was instilled into the right conjunctival sac of 6 New Zealand White rabbits. The left eyes were not treated and served as control. The eyes were not rinsed after administration of the test item. 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 calculated for animals over 24, 48 and 72 hours were 0.2 chemosis, 0.5 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Under these experimental conditions, the di-tert-amyl peroxide was slightly irritant when administered by ocular route to rabbits.