Registration Dossier

Diss Factsheets

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
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)
Deviations:
yes
Remarks:
The positive control is 10% (w/v) Benzalkonium chloride (purity not indicated by the producer) in saline since the laboratory historical control data is established with this chemical.
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,10-Decanediamine, 4-methylbenzenesulfonate (1:2)
EC Number:
855-905-0
Cas Number:
1326716-46-4
Molecular formula:
C24H40N2O6S2 (C10H24N2 • 2 C7H8O3S)
IUPAC Name:
1,10-Decanediamine, 4-methylbenzenesulfonate (1:2)
Test material form:
solid

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
284.56

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The calculated mean in vitro irritancy score was 284.56. According to OECD 437 (see table in chapter 3.8.3) the test item is classified as serious eye damaging (EU CLP/UN GHS Category 1).
Executive summary:

This in vitro study was performed to assess the corneal irritation and damage potential of Clevios K Primer W8 dry by means of the BCOP assay using fresh bovine corneae.

After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item Clevios K Primer W8 dry as well as the positive and the negative controls were each applied to different corneae fixed in an incubation chamber in horizontal position and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained incubation medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240).

After the opacity measurements, permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.

With the negative control (physiological saline), neither an increase of opacity nor permeability of the corneae was observed.

The positive control (10% (w/v) benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye damage (EU CLP/UN GHS Category 1).

Relative to the negative control, the test item Clevios K Primer W8 dry caused an increase of the corneal opacity and permeability. The calculated mean in vitro irritancy score was 284.56. According to OECD 437 (see table in chapter 3.8.3) the test item is classified as serious eye damaging (EU CLP/UN GHS Category 1).