Reaction products of fatty acids, C12-14 (even numbered) alkyl and triglycerides, C16 and C18 (unsaturated) alkyl with 2-(2-aminoethylamino)ethanol and sodium chloroacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following in-vitro guideline under validation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2002

Materials and methods

Principles of method if other than guideline:

Ocular Irritection Assay System (refinement of the former Eyetex method)The system evalutes the ocular hazard effects of test chemicals based on the premise that eye irritation and corneal opacity after exposure to rirritating substances is the result of perturbation or denaturation of corneal proteins. The test method maels use of a macromolecular reagent composed of a mixture of proteins and glycoproteins, carbohydrates, lipids and low molecular weight components, which when rehydrated, form an ordered molecular matrix mimicking the structure of the transparent cornea. Irritatn substances produce a turbidity of the reagent by changing both protein conformation and degree of hydration. Changes in the turbidity of the reagent solution caused by the tested material can be quantified by measuring an increase in the light scattering detected at a wavelenght of 405 nm with the help of a spectrometer. The increase in optical density produced by the test material is compared with that prodcued by a set of calibration substances eahc of which having rpeviously estimated in vivo irritancy potential.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of fatty acids, C12-14 (even numbered) alkyl and triglycerides, C16 and C18 (unsaturated) alkyl with 2-(2-aminoethylamino)ethanol and sodium chloroacetate

EC Number:

942-589-5

Molecular formula:

not applicable

IUPAC Name:

Reaction products of fatty acids, C12-14 (even numbered) alkyl and triglycerides, C16 and C18 (unsaturated) alkyl with 2-(2-aminoethylamino)ethanol and sodium chloroacetate

Details on test material:

The substance was used either as dehydrated sample (for phys-chem properties) or as solution at 30% (for in vitro skin irritation)

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

Reagent pH before activation: 8.19Reagent pH after activation: 5.98Reagent temperature: 25°CKit Lot Number: 110700

Test system

Amount / concentration applied:

1, 5, 10 and 25%

Duration of treatment / exposure:

5h

Results and discussion

In vitro

Results

Irritation parameter:

other: opacity

Remarks on result:

other: results are reported in the relevant section

Any other information on results incl. tables

Dose	irritation score
1	24.5
5	23.2
10	25.8
25	25.8

Applicant's summary and conclusion

Interpretation of results:

other: classified under Regulation 1272/2008

Conclusions:

The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Under the experimental conditions the substance showed eye irritation properties.

Executive summary:

The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Doses of 1, 5, 10 and 25 % of the test item were applied to the matrix mimicking the ordered structure of the cornea for 5h. Irritection score were all in the mild range. Under the experimental conditions the substance showed an increase in turbidity and therefore eye irritation properties classified as H319 Category 2.