In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial
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In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial. / Mewes, Karsten R; Engelke, Maria; Zorn-Kruppa, Michaela; Bartok, Melinda; Tandon, Rashmi; Brandner, Johanna M; Petersohn, Dirk.
in: ALTEX-ALTERN ANIM EX, Jahrgang 34, Nr. 3, 2017, S. 430-434.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial
AU - Mewes, Karsten R
AU - Engelke, Maria
AU - Zorn-Kruppa, Michaela
AU - Bartok, Melinda
AU - Tandon, Rashmi
AU - Brandner, Johanna M
AU - Petersohn, Dirk
PY - 2017
Y1 - 2017
N2 - Aim of the present ring trial was to prove whether two new methodological approaches for the in vitro classification of eye irritating chemicals can be reliably transferred from the developers' laboratories to other sites.Both test methods are based on the well-established open source reconstructed 3D hemicornea models. In the first approach, the initial depth of injury in the hemicornea model after chemical treatment is derived from the quantitative analysis of histological sections. In the second approach tissue viability, as a measure for corneal damage after chemical treatment, is analyzed separately for epithelium and stroma of the hemicornea model. The 3 independent laboratories which participated in the ring trial produced their own hemicornea models according to the test producer's instructions, thus supporting the open source concept. A total of 9 chemicals with different physico-chemical and eye-irritating properties were tested to assess the between-laboratory reproducibility (BLR), the predictive performance as well as possible limitations of the test systems. The BLR was 62.5% for the first and 100% for the second method. Both methods enabled to discriminate cat 1 chemicals from all non-cat 1 substances, which qualifies them to be used in a top-down approach. However, the selectivity between no cat and cat 2 chemicals still needs optimization.
AB - Aim of the present ring trial was to prove whether two new methodological approaches for the in vitro classification of eye irritating chemicals can be reliably transferred from the developers' laboratories to other sites.Both test methods are based on the well-established open source reconstructed 3D hemicornea models. In the first approach, the initial depth of injury in the hemicornea model after chemical treatment is derived from the quantitative analysis of histological sections. In the second approach tissue viability, as a measure for corneal damage after chemical treatment, is analyzed separately for epithelium and stroma of the hemicornea model. The 3 independent laboratories which participated in the ring trial produced their own hemicornea models according to the test producer's instructions, thus supporting the open source concept. A total of 9 chemicals with different physico-chemical and eye-irritating properties were tested to assess the between-laboratory reproducibility (BLR), the predictive performance as well as possible limitations of the test systems. The BLR was 62.5% for the first and 100% for the second method. Both methods enabled to discriminate cat 1 chemicals from all non-cat 1 substances, which qualifies them to be used in a top-down approach. However, the selectivity between no cat and cat 2 chemicals still needs optimization.
U2 - 10.14573/altex.1610311
DO - 10.14573/altex.1610311
M3 - SCORING: Journal article
C2 - 28088129
VL - 34
SP - 430
EP - 434
JO - ALTEX-ALTERN ANIM EX
JF - ALTEX-ALTERN ANIM EX
SN - 1868-596X
IS - 3
ER -
