PALMARIA PALMATA EXTRACT

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 2006

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:

2007

Report date:

2007

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Enzymatic hydrolysis products of Palmaria palmata extract

EC Number:

607-053-4

Cas Number:

223751-74-4

IUPAC Name:

Enzymatic hydrolysis products of Palmaria palmata extract

Test material form:

liquid

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):

N/A

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 (%)

Value:

> 50

Other effects / acceptance of results:

The per cent mortality observed with 50% of the test item, is to 5%.

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 the test item is thus negligible to eye (IC50 >50 and % mortality observed with 50% of the test item is comprised between < 20).

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 the test item is thus negligible to eye (IC50 >50 and % mortality observed with 50% of the test item is comprised between < 20).