Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
2002
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 are the result of perturbation or denaturation of corneal proteins. The test method makes 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. Irritating 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 produced by a set of calibration substances each of which having previously estimated in vivo irritancy potential.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
UVCB substancePhysical form: liquidsolubility/dispersability > 300 g/ltest item storage: room temperature, protected from lightStability: stable under storage conditionsExpiry date: 31 December 2018

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   
16.1   
 5  30.5  
 10  15.9  
 25  16.1  

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,except one, in the mild range. Under the experimental conditions the substance showed an increase in turbidity and therefore eye irritation properties classified as H318, Category 1.