Registration Dossier

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:
other: GLP study according to OECD guideline 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L-dilactide
- Analytical purity: >99.5%
- Lot/batch No.: DA 778 FN
- 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 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 12h light/12h 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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, in the acute dermal irritation/corrosion study accordign to OECD 404, the test item L-dilactide is considered to be non-irritating.
Executive summary:

A sample of L-dilactide (> 99.5%) was tested in female rabbits for acute dermal irritating properties according to OECD guideline 404. The dermal exposure period was 4 hours under semi-occlusive conditions. L-dilactide did not cause any skin effects. Thus, under the conditions of this study, L-dilactide can be considered non-irritating.