Registration Dossier
Registration Dossier
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EC number: 700-786-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1993
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola
- EC Number:
- 700-786-1
- Cas Number:
- 1194682-64-8
- IUPAC Name:
- Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye of the same rabbit
- Amount / concentration applied:
- 0.1 ml of undiluted product in the right eye
- Duration of treatment / exposure:
- eye closed 1s then after 1h the rabbit is back in the cage
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, then till 14 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- within 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2.7 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Irritant / corrosive response data:
- This substance is irritating for the rabbits eyes. their cornea is blessed during 48h. This effect has totally disappeared after 6 to 8 days.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- This substance is considered irritating for eyes
- Executive summary:
1h after instillation, the tested substance produced an important irritation on the conjunctiva producing redness and intense oedema.The mean values are calculated to be 3.
These reactions decreased after 1 week and completely dissapeared after 13 days. They appeared together with an important lacrimation that stay up to 5/6 days
A congestion in the iris is noted after 1h of contact, this reaction is fully reversible in the 3 rabbits after 1 week
The first 48h, the toal surface of the cornea of the 3 rabbits is covered. The total opacity is more important in the rabbit no 2002 and decrease after 72h to be fully reversible after 6/8 days
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