1,4-Dioxane-2,5-dione, 3,6-dimethyl-, (3R,6R)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-06-22 to 1998-07-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione

EC Number:

224-832-0

EC Name:

(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione

Cas Number:

4511-42-6

Molecular formula:

C6H8O4

IUPAC Name:

3,6-dimethyl-1,4-dioxane-2,5-dione

Specific details on test material used for the study:

- Name of test material (as cited in study report): L-dilactide
- Analytical purity: > 99.5 %
- Lot/batch No.: DA 778 FN
- Appearance: white crytalline powder
- bulk density: 0.8 kg/L
- Storage condition of test material: at ca. -20 °C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Upon arrival, the rabbits were checked for overt signs of ill health and anomalies. Test animals were females, young adult and were quarantined 54 or 55 days upon arrival. At the start of the study, body weight was 3060-3405 g. Animals were housed individually in stainless steel cages with perforated floor under a 12 h light/12 h dark cycle at 20 ± 3 °C and 50-76 % humidity (upper limit higher than 70 %, because of wet cleaning of the animal room and/or meteorological circumstances; the 76 % peak occurred for one hour at most); ventilation was ca 10 air changes/hour. Animals were fed standard laboratory rabbit diet ad libitum. Each batch of this diet is analyzed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are available upon request). Tap water (N.V. Waterleidingbedrijf Midden-Nederland) was available ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are available upon request.
Three or four days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. The clipping was repeated if considered necessary.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance, moistened with 0.5 mL water

Duration of treatment / exposure:

4 hour exposure

Observation period:

Observation at 1, 24, 48, 72 hours after exposure

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: diameter: ± 2.5 cm
- % coverage: Full
- Type of wrap if used: Covered with a cup.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Moistened tissue
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize et al. (1944)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

At 1-72 hours after treatment, no signs of skin irritation were observed in any of the three rabbits.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

In conclusion, in the acute dermal irritation/corrosion study conducted according to OECD 404, the test item L-lactide is considered to be non-irritating.

Executive summary:

In a primary dermal irritation study conducted according to OECD Guideline 404, female young adult SPF bred New Zealand White albino rabbits (n= 3) were dermally exposed to 0.5 g of L-lactide (purity: >99.5%) under semi-occlusive for 4 hours. Animals then were observed 1, 24, 48 and 72 hours after exposure. Irritation was scored by the method of Draize et al. (1944).

In this study, L-lactide did not cause any skin effects. Thus, under the conditions of this study, L-lactide can be considered as non-irritating.