Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-06-04 to 1998-07-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
dosing-volume of 0.01 ml powdered onto the cornea, instead of 0.1 ml instilled in the conjunctival cul-de-sac.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): L-dilactide
- General appearance: white crystalline powder
- Lot/batch No.: DA 778 FN
- Storage condition of test material: at ca. -20°C
- bulk density: 0.8 kg/L
- Analytical purity: >99.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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 days upon arrival. At the start of the study, body weight was 2917-3085 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.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.01 mL of the test substance (i.e. 0.008 g, density to be: 0.8 kg/L)
Duration of treatment / exposure:
The rabbit selected was treated as follows: An amount of ca 0.01 ml of the test substance (i.e. ca 0.008 g; density to be ca 0.8 kg/L) was powdered onto the cornea of the right eye. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The left eye remaining untreated, served as a control.
Observation period (in vivo):
The reactions of the test eyes were judged at circa 1, 24, 48, and 72 hours, and at 7 days after treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.43
Max. score:
1.3
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
0.3
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.13
Max. score:
1.7
Reversibility:
fully reversible within: 7d

Any other information on results incl. tables

Table 1: Mean values for corneal opacity, iritis, redness and swelling of the conjunctivae of each rabbit scored at 24, 48, 72 hours after treatment with L-dilactide
 
Animal Opacity Iritis Redness Swelling
   
A19 0.0 0.0 0.3 0.0
A21 1.3 0.3 2.7 1.7
A23 0.0 0.0 3.0 1.7

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, in this acute eye irritation/corrosion study according to OECD 405, L-dilactide is inducing reversible irritation in the eyes of rabbits.
Executive summary:

L-dilactide (> 99.5%) was tested for acute eye irritating properties in an experiment with three albino rabbits according to OECD guideline 405. Undiluted substance (0.01 ml) was powdered onto the cornea and caused slight to moderate corneal opacity, slight iritis, slight to severe redness (score >2) and slight to severe swelling on the conjunctivae and severe ocular discharge in the rabbits. At 7 days after treatment, all eye effects had cleared completely.

Based on the results it was concluded, that L-dilactide is irritating for the eyes of rabbits and needs be to classified as eye irritant (CLP category 2).