Rye, ext.

Eye irritation

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

Test material information

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).