Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Remarks:
Study performed according to Fr ench offical method published in December 1999 in National register N° 302, and Good Laboratory Practice

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Principles of method if other than guideline:
Neutral red release method : alternative study to animal experimentation used in a set of tests to determine the ocular irritant potential of cosmetic products.
The principle is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Rye, ext.
EC Number:
290-271-3
EC Name:
Rye, ext.
Cas Number:
90106-48-2
IUPAC Name:
Oligosaccharides and polysaccharides of glucose from Rye
Test material form:
liquid
Details on test material:
- Appearance: yellow
- Storage In darkness at room temperature

- Manufacturing date: April 2005
- Expiry date: October 2006

Test animals / tissue source

Species:
rabbit
Strain:
other: SIRC line
Details on test animals or tissues and environmental conditions:
Rabbit cornea fibroblasts are suspended in a culture medium composed of MEM supplemented with 10% fetal calf serum (FCS) and antibiotics (penicillin - streptomycin (5 000 U/ml)).

Test system

Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
5, 15, 25, 35 and 50%
Duration of treatment / exposure:
60 seconds or 30 seconds for surface active products
Observation period (in vivo):
-
Duration of post- treatment incubation (in vitro):
not specified
Number of animals or in vitro replicates:
Only a duplicate for the 50% concentration.
Details on study design:
The test item is diluted in 0.9% sodium chloride to obtain the following concentrations: 5, 15, 25, 35 and 50%.
These dilutions are tested once except the 50% dilution which is tested twice.

Results and discussion

In vitro

Results
Irritation parameter:
other: IC50 (%)
Run / experiment:
Mean
Value:
> 50
Other effects / acceptance of results:
The per cent mortality observed with 50% of the test item, is to 22%.

In vivo

Irritant / corrosive response data:
The cytotoxicity of COHELISS is thus slight to eye (IC50 >50 and % mortality observed with 50% of test item is comprised between 20 and 50).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The determination of the irritant potential by direct application of a monolayer of rabbit cornea fibroblasts according to the method of neutral red release was made on the test item.
The cytotoxicity of COHELISS is thus slight to eye (IC50 >50 and % mortality observed with 50% of the test item is comprised between 20 and 50).
Executive summary:

The determination of the irritant potential by direct application of a monolayer of rabbit cornea fibroblasts according to the method of neutral red release was made on the test item.

The cytotoxicity of COHELISS is thus slight to eye (IC50 >50 and % mortality observed with 50% of the test item is comprised between 20 and 50).