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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:
weight of evidence
Study period:
28 Feb 2012 - 06 Mar 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1a of February 10, 2010
Qualifier:
according to
Guideline:
other: Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing In Vitro Eye Irritation Assays for Entry into Formal Validation: Technology Transfer and Intra/Inter Laboratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, Society of To
GLP compliance:
yes (incl. certificate)
Remarks:
BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid/white
- Analytical purity: 99.0 g/100 g determined by 1H-MR spectroscopy
- Expiration date of the lot/batch: July 15, 2015
- Storage condition of test material: Room temperature; avoid temperatures > 35°C

Test animals / tissue source

Species:
other: Reconstructed human cornea model EpiOcular(TM)
Strain:
other: Tissue model: OCL-200
Details on test animals or tissues and environmental conditions:
N/A

Test system

Vehicle:
other: tissue was pretreated with PBS, test item added unchanged
Controls:
other: Two tissues were each treated with positive and negative controls
Amount / concentration applied:
50 µl of test material
Duration of treatment / exposure:
90 minutes
Number of animals or in vitro replicates:
Two tisssues per sample
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with sterile PBS
- Time after start of exposure: 90 minutes

Results and discussion

In vitro

Results
Irritation parameter:
other: tissue viability in %
Run / experiment:
test material
Value:
98
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

RESULTS

tissue 1 tissue 2 mean inter-tissue variability [%]
negative control

mean OD570

1.488 1.665 1.577
viability [% of NC] 94.4 105.6 100 11.2
test material

mean OD570

1.419 1.685 1.522
viability [% of NC] 90 106.9 98 16.9
positive control

mean OD570

0.296 0.327 0.311
viability [% of NC] 18.7 20.7 20 2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the observed results it was concluded, that the test substance does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
Executive summary:

The potential of the test article to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 19 mg) of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples were incubated with the test substance for 90 minutes followed by a 18-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results:

The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 98%. Based on the observed results it was concluded, that the test substance does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.