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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
Study period:
21 November 2017 - 21 November 2017
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)
Version / remarks:
July, 2013
Deviations:
no
Qualifier:
according to
Guideline:
EU method B.47 (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
Specific details on test material used for the study:
Batch: 1013Q17761
Purity: 100%
Appearance: White powder
Expiry Date: 25 June 2017
Storage Conditions: At room temperature

Test animals / tissue source

Species:
cattle
Details on test animals or tissues and environmental conditions:
Freshly isolated bovine cornea (at least 9 month old donor cattle).

Test system

Vehicle:
physiological saline
Remarks:
20% suspension (w/v)
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
0.75 mL each on the surface of the corneae
Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
Triplicate

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
19.89
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
For the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.00).
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae (mean IVIS =138.03) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
According to OECD 437 no prediction for the damage hazard of the substance to the eye can be made, but the substance is not serious eye damaging (CLP/EPA/GHS (Cat 1).
Executive summary:

The eye hazard potential of the substance as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea was assessed using the Bovine Corneal Opacity and Permeability test (BCOP test). The eye damage of the substance was tested through topical application for approximately 240 minutes.  The substance did not induce ocular irritation through both endpoints (opacity and permeability), resulting in a mean in vitro irritancy score (IVIS) of 19.89 after 4 hours of treatment. In conclusion, since the substance caused an increase of the corneal opacity, according to OECD 437, no prediction for the damage hazard of the substance to the eye can be made, but the substance is not serious eye damaging (CLP/EPA/GHS (Cat 1).