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
Study period:
September 7, 2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: CarboNeXT
Physical state: fine powder
Colour: greyish
Storage conditions: at room temperature, protected from light

Results and discussion

In vivo

Results
Irritation parameter:
other: opacity
Basis:
mean
Time point:
other: 90 minutes
Score:
2.88
Reversibility:
fully reversible

Any other information on results incl. tables

The eye irritancy potential of CarboNeXT was invistigated in the bovine corneal opacity and permeability assay.

The test item was diluted with physiological saline 0.9% NaCl to gain a 20% concentration.

The following mean in vitro score was calculated: 2.88

Therefore the test item was classified as non irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the evalutation criteria the test item CarboNeXT is classified as non eye irritant.