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: In compliance with GLP and OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: French Norm française ffrom AFNOR for chemicals : NF T 03-264
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name : LAB 3085 (Isosorbide)
Order number : E0106
Reference : lot E1011
Supplier : ROQUETTE - Research Dpt
Conditioning : hermetic plastic bag
Used quantity : 6.6g
Date of reception : 13.02.01
Presentation : White cristals

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Supplier : Centre d'élevage et de sélection BARROIS - 59152 TRESSIN - France
Number/sex : 6 males
Weight : 1.8 to 2.0 kg
Age : 50 to 60 days when arrived at the laboratory
Identification: sign with a felt-tip into the right ear

Housing : stainless steel grid cages
Feed : A04C 112 - UAR - 91360 VILLEMOISSON/ORGE - France - stainless steel feeding tray - daily dose: 130g
Drinking : potable water - given ad libitum
Environment : Temperature : 21 +/-2°C - Relative humidity : 50+/-10% - Light/dark cycle : 12h/d - air renewable : 12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1g by instillation
Observation period (in vivo):
1h, 2 days, 3 days, 4days and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
One dose of the item is instilled in one eye. The other eye becomes the eye reference.

SCORING SYSTEM:average of the two observations executed by two readers.
Determination of the Individual ocular irritation index (IOI) , medium ocular irritation index (IOM) and Acute ocular irritation index (IOA)


TOOL USED TO ASSESS SCORE: ophtalmoscope type M IROFLEX ®2

No particular observation during the visual examination before the instillation.
No particular observation concerning the behavior and the general state of animals.
No particular observation during the instillations and applications of the item.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h, 2days, 3days, 4days and 7days
Score:
0
Irritation parameter:
other: watering
Basis:
mean
Time point:
other: 1h, 2days, 3days, 4days and 7days
Score:
0
Irritation parameter:
other: conjonctiva enanthema, redness and tumefaction
Basis:
mean
Time point:
other: 1h, 2days, 3days, 4days and 7days
Score:
0
Irritation parameter:
iris score
Remarks:
reflex and congestion
Basis:
mean
Time point:
other: 1h, 2days, 3days, 4days and 7days
Score:
0
Irritation parameter:
cornea opacity score
Remarks:
opacification (degree and surface)
Basis:
mean
Time point:
other: 1h, 2days, 3days, 4days and 7days
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: AFNOR NF T03-264, OECD 405 and norm 16 CFR1500-42
Conclusions:
LAB 3085 is classified as not irritant for the eyes.
Executive summary:

Locale tolerance study on New-Zealand rabbit, eye irritation

Number study : 01231

Assay item : LAB 3085

Guideline : OECD 405 and French norm AFNOR : NF T 03 -264

Results : After instillation of the right eye with the item and according the norm AFNOR NF T 03 -264, no ocular irritation was observed.

After instillation of the right eye with the item and according the norm OECD 405, no ocular irritation was observed.

Conclusion : LAB 3085 is classified as not irritant for the eyes, on the basis of the experimental study : 0.1 g of item on its own, in the fornix of conjonctiva and an observation during 7 days.