Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μL of the test item preparation or the control substance was introduced into the anterior chamber (closed-chamber method).
The test item was suspended with physiological saline 0.9% NaCl to give a 20% concentration.
Duration of treatment / exposure:
After 4 hours ± 5 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red).
Number of animals or in vitro replicates:
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive controls treated with ethanol 100%

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean value
Value:
ca. 105.52
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Irritation parameter:
cornea opacity score
Run / experiment:
Mean value
Value:
105.64
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
According to the evaluation criteria the test item Basic Yellow 1 is classified into UN GHS Category 1.
Executive summary:

The eye irritancy potential of Basic Yellow 1 was investigated in the bovine corneal opacity and permeability assay.

Preparation of the test item: The test item was suspended with physiological saline 0.9% NaCl (see 10.3) to give a 20% concentration.

Visual Observation after treatement: All 3 corneas treated with Basic Yellow 1 showed complete opacity of the tissue.

Mean in vitro irritation score: 105.52

Classification: UN GHS Category 1

The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.

The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.

Conclusion

According to the evaluation criteria the test item Basic Yellow 1 is classified into UN GHS Category 1.