Registration Dossier

Toxicological information

Eye irritation

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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:
2014

Materials and methods

Test guideline
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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Isolated bovine cornea: The test system (target tissue) is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).

Test system

Vehicle:
other: De-ionized water
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
20% (w/v) solution in de-ionized water
Duration of treatment / exposure:
The corneas were incubated in a horizontal position at about 32 °C for approximately 4 hours (non-surfactant solids).
Number of animals or in vitro replicates:
Each treatment group (test substance, NC and PC) consisted of 3 corneas

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
2.6
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
The IVIS score of the test substance of 2.6 would classify it as a substance that does not cause eye irritation or serious eye damage
Conclusions:
Applying the criteria of the OECD 437 for the assessment of the BCOP test results, the IVIS score of the test substance of 2.6 would classify it as a substance that does not cause eye irritation or serious eye damage. However, the Guideline also states, that due to limited accuracy of the BCOP test to correctly identify substances that do not require classification for eye irritation or serious eye damage, this test method should not be the first choice to initiate a bottom-up approach. Based on this statement test substances leading to IVIS <3 are generally examined in the EpiOcular test as well.