3,5-dimethyl-1,2-dioxolane-3,5-diol

Eye irritation

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: The test generally satisfies the GLP regulations and specific test guideline (OECD 405). Minor deficiiencies: the concentration/purity of the test substance could not be verified from the Certificate of Analysis

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(The test substance characterization and stability data, while available, were not developed in accordance with the (GLP) standard. The report stated that this deviation was not expected to impact the study results.)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,5-dimethyl-1,2-dioxolane-3,5-diol

Cas Number:

13784-51-5

IUPAC Name:

3,5-dimethyl-1,2-dioxolane-3,5-diol

Details on test material:

In the Study Report, the test material, Trigonox 44B, a clear colorless liquid, was stated to have been identified by the Batch No. 0419207045262, CAS Nos 37187-22-7, 123-42-2, and 111-46-6 and the EINECS Nos. 2533849, 2046267, and 2038722. It was stated to be 33% Acetylacetone Peroxide in solvent (Diethylene glycol, water and diacetone alcohol. The Certificate of Analysis contains only the batch number, but not the expiration date of the test substance. In the Study report, the identity, strength and purity of the test material, and the stability under sstorage conditions were stated to be the responsibility of the Sponsor.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:Supplied by Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England.
- Age at study initiation: 3.5 - 4.5 months.
- Weight at study initiation: 3.04 - 3.44 kg
- Housing: Individually housed in suspended stainless cages
- Diet (e.g. ad libitum): standard pelleted rabbit diet, ad libitum.
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: Acclimatized rabbits were used; 8 -1 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 19 degrees Celcius
- Humidity (%): 49 - 56%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 5 October, 1992 to 18 November, 1992.

Test system

Vehicle:

other: None

Controls:

no

Amount / concentration applied:

0.1 ml of the test substance, as provided by the Sponsor.

Duration of treatment / exposure:

Test material was instilled once into the right eye.

Observation period (in vivo):

1, 24, 48, and 72 hours and 7 days after treatment.

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

A standard study design was used. Rabbits were observed at 1,24, 48, 72 hours and 7 days after treatment and ocular lesions were scored. For each animal, the left eye (untreated eye) was used for comparison for assessing the ocular lesions.

REMOVAL OF TEST SUBSTANCE
- Washing: Exposure was not followed by washing

SCORING SYSTEM: According to the Guidelines on Eye Irritation Tests (Draize Eye Test), UK Home Office, (1986).

Additional scoring systems were used for the assessment of pain response and ocular lesions in Cornea (not a component of regulatory guidelines).

TOOL USED TO ASSESS SCORE: An ophthalmoscope was used to inspect the eyes. Corneal lesions were confirmed by fluorescein treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(Animal Number and Sex: 28TD 468M)

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Pain Evaluation Response: 3

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(Animal Number and Sex: 28TD 468M)

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

animal #1

Remarks:

(Animal Number and Sex: 28TD 468M)

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Remarks:

(Chemosis of Conjunctiva)

Basis:

animal #1

Remarks:

(Animal Number and Sex: 28TD 468M)

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(Animal Number and Sex: 28TD 479M)

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(Animal Number and Sex: 28TD 479M)

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

animal #2

Remarks:

(Animal Number and Sex: 28TD 479M)

Time point:

24/48/72 h

Score:

1.7

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Remarks:

(Chemosis of Conjunctiva)

Basis:

animal #2

Remarks:

Animal Number and Sex: 28TD 479M)

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

overall irritation score

Remarks:

(Cornea, Iris and Conjunctiva (redness and chemosis) were evaluated similar to other animals)

Basis:

animal #3

Remarks:

(Animal Number and Sex: 28TD 480M)

Time point:

other: 1 and 24 hours post-treatment

Reversibility:

not reversible

Remarks on result:

other: A diffuse crimson-red conjuctival appearance, severe discharge, moderate chemosis, stippling of the cornea/iritis was evident an hour of treatment. Additional lesions and hemorrhage were also seen at 24 hrs. The rabbit was humanely killed immediately.

Irritant / corrosive response data:

Data provided above.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Due to the severe response observed in one animal, the test material was considered to be irritating to the eye with the potential to cause serious ocular damage, although the ocular scores for the animals used on this study did not reach the EEC limit value for a positive result.

Executive summary:

The acute eye irritation potential of Trigonox 44B was assessed in three New Zealand White rabbits under the OECD 405 test guideline. Due to the severe response observed in one animal at 1 and 24 hours, this animal was humaley sacrificed. The test material was considered to be irritating to the eye with the potential to cause serious ocular damage, although the ocular scores for the animals used on this study did not reach the EEC limit values for a positive result.