Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch no: DA 778 FN
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 12hlight/12hdark 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:
8 mg in one eye.
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/1) 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 one, 24, 48, and 72 hours, and at 7 days after treatment
Number of animals or in vitro replicates:
3
Details on study design:
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/1) 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.

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
L-lactide is moderately irritating for the eyes
Executive summary:

An eye irritation study with rabbits was performed, following the Low-Volume-Procedure which is considered to represent a more realistic human ocular exposure than the convential method with 0.1 ml dosing-volume.

In the present study the test substance was powdered onto the comea resulting in slight or moderate comeal reactions in two rabbits and slight to severe conjunctival effects, which were all fully reversible within 7 days after treatment.

On the basis of these results it was concluded that, under the conditions of this study, L-dilactide is moderately irritating for the eyes of rabbits. According to the EC-standards L-dilactide would be considered as irritating to (human) eyes.