Fatty acids, C16-18 and C18-unsatd., reaction products with glycidyl neodecanoate and 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

: Esterification reaction of fatty acids, C16-18 and C18-unsatd.; 3,4-epoxycyclohexyl methyl-3,4-epoxycyclohexan carboxylate and neodecanoic acid, oxiranylmethyl ester

Molecular formula:

not available for UVCB substances

IUPAC Name:

: Esterification reaction of fatty acids, C16-18 and C18-unsatd.; 3,4-epoxycyclohexyl methyl-3,4-epoxycyclohexan carboxylate and neodecanoic acid, oxiranylmethyl ester

Test material form:

liquid

Details on test material:

UVCB Purity 100% Batch number:210164480 Expiration Date: 16 December 2017

Test animals / tissue source

Species:

other: cattle

Strain:

other: Bos primigenius Taurus

Details on test animals or tissues and environmental conditions:

Bovine corneas were obtained from slaughtered cattle which were bettween 12 and 60 months old.

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

750 ml applied directly on the entire surface of the cornea

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 hour incubation, then washed, and incubated for an additional 90 min.

Details on study design:

SELECTION AND PREPARATION OF CORNEAS: examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 h in the incubation chamber at 32 ± 1 °C.

QUALITY CHECK OF THE ISOLATED CORNEAS: performed and checked for tissue damage.

NUMBER OF REPLICATES: 3

NEGATIVE CONTROL USED: 0.9% sodium chloride

SOLVENT CONTROL USED (if applicable)

POSITIVE CONTROL USED: DMF

APPLICATION DOSE AND EXPOSURE TIME: see above

TREATMENT METHOD: closed chamber

POST-INCUBATION PERIOD: yes. If YES please specify duration: see above

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 1 set of multiple rinses, using cMEM without phenol red
- POST-EXPOSURE INCUBATION: yes, 90 min

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured by placing the cornea in a spectral photometer and recording the absorbance at 570 nm.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490): yes
-

SCORING SYSTEM: In Vitro Irritancy Score (IVIS), see above

DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used. yes

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

0.41

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The test substance caused no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41. All controls were valid and within historical control ranges.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41. As the value is below 3, the substance is not an eye irritant.