Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Version / remarks:
HET-CAM test has been officially accepted by French Authorities as an alternative to animal experimentation (Published in the Official Journal of French Republic of december 26, 1996)
Principles of method if other than guideline:
The principe of this method is based on the observation, by a trained person, of the occurence of vascular injury or coagulation over 5-minute period, in response to a compound placed directly onto chorionallantoic membrane of a 10th day incubated hen's egg.
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: whitish scales

Test animals / tissue source

Species:
chicken
Strain:
other: white Leghorn

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
concentration of omega 6 ceramide : pure (100%)
volume : 0.3 mL
Duration of treatment / exposure:
exposure time : 20 sec
Observation period (in vivo):
5 min
Number of animals or in vitro replicates:
4

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
egg 1 : pure test item
Value:
3
Remarks on result:
other: slightly irritant
Irritation parameter:
in vitro irritation score
Run / experiment:
egg 2 : pure test item
Value:
0
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
egg 3 : pure test item
Value:
0
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
egg 4 : pure test item
Value:
3
Remarks on result:
other: slightly irritant
Irritation parameter:
in vitro irritation score
Run / experiment:
vehicule control
Value:
0
Vehicle controls validity:
valid
Remarks:
score : 0 to <1
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
positive control
Value:
12
Positive controls validity:
valid
Remarks:
score : >10 to >14
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In regard to the HET-CAM test, the pure test item omega 6 ceramide is considered as slightly irritant.
Executive summary:

The evaluation of the ocular irritant potential was conduced using the HET-CAM test (chorionallantoic membrane of hen's eggs). HET-CAM test has been officially accepted by French Authorities as an alternative to animal experimentation ( Published in the Official Journal of French Republic of december 26, 1996).

In the experimental conditions, the pure test item omega 3 ceramide obtained a score of 1.5. It is considered as slightly irritant.