Registration Dossier
Registration Dossier
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EC number: 211-492-3 | CAS number: 652-67-5
Eye irritation
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:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: French Norm française ffrom AFNOR for chemicals : NF T 03-264
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-D-glucitol
- EC Number:
- 211-492-3
- EC Name:
- 1,4:3,6-dianhydro-D-glucitol
- Cas Number:
- 652-67-5
- Molecular formula:
- C6H10O4
- IUPAC Name:
- 1,4:3,6-dianhydro-D-glucitol
- 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
Constituent 1
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.
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