Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008/09/06 to 2008/09/06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deviation was registred during the study. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n°405 and has been performed in compliance with the Good Laboratory Principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2007

Test material

Constituent 1
Reference substance name:
LCE 08083
IUPAC Name:
LCE 08083
Details on test material:
- batch n°: T73615
- Form: pearls
- Colour: beige
- Storage: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animal:
- species: new zealand albino rabbits
- Origin: Elevage de Gérome (Quartier Labaste-F40260 Linxe)
- Acclimatation period: 5 days
- Weight: between 2.49 and 3.11 kg (during the test)
- Old: 12 to 13 weeks

Housing:
-T° between 19 and 23°C
- Relative humidity: between 38 and 50%
- Lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour

Food and drinking:
- Drinking water and foodstuff were supplied freely
- Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated serving as control.
Amount / concentration applied:
0.1g of the test item, reduced in fine powder were introduced into the conjunctival sac of the eye.
Observation period (in vivo):
if no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.
Number of animals or in vitro replicates:
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D7, two additional animals were treated.
Details on study design:
Occular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
the 3 animals
Time point:
other: 24-72h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72h
Score:
ca. 2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72h
Score:
ca. 6
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72h
Score:
ca. 3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72h
Score:
ca. 2
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72h
Score:
ca. 0
Irritant / corrosive response data:
According to the calculated mean, the test item must not be classified, in accordance with the european regulation.
Other effects:
The occular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between D3 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D1 and D3.
- at the corneal level: a moderate opacity, only rehistered 24 hours after the test item instillation in one animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is
- slightly irritant for eye (I.O.=11.3) according to the classification established in the journal officiel de la république francaise dated July 10th, 1992.
- and must not be classified according to the criteria for classification, packaging and labelling of dangerous substances in compliance with EEC directive 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the GHS, the test item must not be classified category 2. No signal word and hazard statement are required.
Executive summary:

The test item LCE 08083 was instilled as supplied, at the dose of 0.1g into the eye of three New Zealand rabbits. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n°405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC

The occular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:

- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between D3 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D1 and D3.

- at the corneal level: a moderate opacity, only rehistered 24 hours after the test item instillation in one animal.

The test item must not be classified according to the criteria for classification, packaging and labelling of dangerous substances in compliance with EEC directive 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.

In accordance with the GHS, the test item must not ba classified category 2. No signal word and hazard sttement are required.