Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1993
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
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:
not specified

Test material

Constituent 1
Reference substance name:
sophoroses-lipides
IUPAC Name:
sophoroses-lipides

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of the sale 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

Results
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24h
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible
Remarks:
within 14 days
Remarks on result:
other: max 4 at days 6 and 7
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:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
This substance is irritating for eyes