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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to OECD 437 resp. EU Method B.47 Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): CAS No. 135452-43-6

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
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
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test system

Vehicle:
other: olive oil
Duration of treatment / exposure:
incubation time: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: IVIS (in vitro irritancy score)
Basis:
other: Test group 1
Time point:
other: 4 hours (incubation time)
Score:
0.933
Irritation parameter:
other: IVIS (in vitro irritancy score)
Basis:
other: Test group 2
Time point:
other: 4 hours (incubation time)
Score:
1.06
Irritation parameter:
other: IVIS (in vitro irritancy score)
Basis:
other: Test group 3
Time point:
other: 4 hours (incubation time)
Score:
0.264
Irritation parameter:
other: IVIS (in vitro irritancy score)
Basis:
other: Mean IVIS
Time point:
other: 4 hours (incubation time)
Score:
0.752

Any other information on results incl. tables

The test item showed no effects on the cornea of the bovine eye. The calculated mean IVIS (in vitro irritancy score) is 0.752.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses no eye irritation potential (according to ICCVAM).

According to OECD 437 (2009), a substance that induces an IVIS >=55.1 is defined as a corrosive or severe irritant.

Therefore, the test item is classified as “non-corrosive” and/or “no severe irritant”.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item showed no effects on the cornea of the bovine eye. It can be stated that in this study and under the experimental conditions reported, the test item possesses no eye irritation potential (according to ICCVAM). It is classified as “non corrosive” and/or “no severe irritant”