Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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)
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
Light yellow solid (powder)

Test animals / tissue source

Species:
cattle
Strain:
other: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
Details on test animals or tissues and environmental conditions:
The cattle were between 12 and 60 months old. The eyes were transported to the test fa-cility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicil-lin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour and 15 minutes.

Test system

Vehicle:
not specified
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 µL
Duration of treatment / exposure:
4 hours at 32 ± 1 °C

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 1.03
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative con-trol showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irri-tancy Score) was 1.30.
20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current histori-cal mean. The calculated mean IVIS was 88.98.
Under the conditions of this study, the test item Chiguard GA403 showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 1.03.

Any other information on results incl. tables

Classification Scheme

IVIS

UN GHS

≤ 3

No category

> 3 and≤ 55

No prediction can be made

> 55

Eye damage Category I

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, the test item Chiguard GA403 showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 1.03.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 re-quires no classification for eye irritation or serious eye damage.