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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 guidelines. Minor deficiiencies: the concentration, purity and stability of the test substance could not be verified from the Certificate of Analysis for the batch of test material.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The test substance characterization/stability data were not presented in accordance with the (GLP) standard. The report stated that this deviation was not expected to impact the study results. This was considered as a minor deficiency only.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The test substance characterization/stability data were not presented in accordance with the (GLP) standard. The report stated that this deviation was not expected to impact the study results. This was considered as a minor deficiency only.

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 of the test substance. No expiration date of the test substance could be found on the Certificate of Analysis. 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Supplied by Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England.
- Age at study initiation: 3 - 3.5 months at dose initiation.
- Weight at study initiation: 2.6 - 2.99 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 - 22 degrees Celcius
- Humidity (%): 45 - 56%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 5 October, 1992 to 22 October, 1992.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: For each animal, the right test site served as the respective control site.

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

Four hours

Observation period:

72 hours

Number of animals:

Three

Details on study design:

Test Site:
- Area of exposure: 3x2 cm
- Type of wrap if used: Semi-occlusive (treated area covered with an unmedicated gauze patch held in place by strips of Blenderm), covered by cottonwool and elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Exposure (4 hours) was followed by gentle washing of the sites with warm water

SCORING SYSTEM: According to the Criteria of Draize (1959), cited in the Study Report.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

other: Mean values of erythema score and edema score were calculated for each animal from 1, 24, 48 and 72 hour post-treatment observations.

Basis:

animal: Three males

Time point:

other: 1, 24, 48 and 72 hours

Score:

ca. 0.3

Reversibility:

fully reversible within: 48 hours (Erythema score)

Remarks on result:

other: Mean Erythema scores and Mean Edema scores were calculated from 24, 48, and 72 hours data for each animal. The only dermal reaction to Trigonox 44B was erythema in two animals (1 hour) and one animal (24 hour), which were reversible.

Any other information on results incl. tables

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No dermal response was observed at anytime except slight erythema in two rabbits during the first 24 hours after treatment. Under the criteria of the EEC, Trigonox 44B was classified as non irritant to the skin.

Executive summary:

The acute dermal irritation potential of Trigonox 44B (CAS 37187 -22 -7) was assessed in three New Zealand White rabbits (4 hour exposure, semi-occluded) under OECD 404 test guideline. No dermal response was observed at anytime except slight erythema in two rabbits during the first 24 hours after treatment. Under the criteria of the EEC, the test substance was classified as non irritant to the skin.