Dipropyl peroxydicarbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dipropyl peroxydicarbonate

EC Number:

240-211-7

EC Name:

Dipropyl peroxydicarbonate

Cas Number:

16066-38-9

Molecular formula:

C8H14O6

IUPAC Name:

1-({[(propoxycarbonyl)peroxy]carbonyl}oxy)propane

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: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mi lis, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: a minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-71
- Humidity (%): 67-84
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 hours and up to 21 days after dosing

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scores

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Exposure to the test article produced corneal opacity in 6/6 test eyes by the 24 hour scoring interval and was confirmed by positive fluorescein dye retention. The corneal opacity resolved in 4/6 test eyes by the 72 hour scoring interval and in the remaining two test eyes by study days 10 and 21, respectively. Iritis was observed in 6/6 test eyes at the 24 hour scoring interval and resolved completely in 4/6 test eyes by the 72 hour scoring interval and in the remaining two by study day 1O. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in 3/6 animals by study day 14 but persisted in the remaining 3 animals (with scores of 1 for redness and/or swelling through the study day 21 scoring interval). Additional ocular findings included sloughing of the corneal epithelium which was noted in 2/6 test eyes and blanching of conjunctival tissue which was noted in 1/6 test eyes.
No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Lupersol 221 is considered to be a severe irritant to the ocular tissue of the rabbit

Executive summary:

The potential irritant and/or corrosive effects of Lupersol 221 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 21 days following dosing. Exposure to the test article produced corneal opacity in 6/6 test eyes by the 24 hour scoring interval and was confirmed by positive fluorescein dye retention. The corneal opacity resolved in 4/6 test eyes by the 72 hour scoring interval and in the remaining two test eyes by the study days 10 and 21, respectively. Iritis was observed in 6/6 test eyes at the 24 hour scoring interval and resolved completely in all animals by study day 10. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in 3/6 animals by study day 14 but persisted in the remaining 3 animals through the study day 21 scoring interval (with scores of 1 for redness and/or swelling through the study day 21 scoring interval). Additional ocular findings included sloughing of the comeal epithelium which was noted in 2/6 test eyes and blanching of conjunctival tissue which was noted in 1/6 test eyes. Mean scores over 24, 48 and 72 hours were 1.2, 0.7, 2.0 and 2.0 for corneal opacity, iritis, conjunctival effects and chemosis, respectively. Under the conditions of this test, Lupersol 221 is considered to be a severe irritant to the ocular tissue of the rabbit.