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EC number: 222-746-8 | CAS number: 3598-16-1
Assay acceptance criteria:
• The mean OD 570 of the negative control tissues is≥1.0 and≤2.5. Actually obtained for water: 1.569.
• The mean tissue viability of the positive control is≤20 %. Actually obtained for 5 %-SDS: 10.5 %.
• The standard deviation calculated from individual percentual tissue viabilities of the 3 identically treated replicates is <18. Actually obtained for the test substance treated tissues: 13.2.
The EpiDerm Skin Irritation Test (Model EPI-200) was performed to reveal possible irreversible tissue damages of the skin following the application of sodium phenoxyacetate. The test substance was topically applied for 60 minutes to the epidermal surfaces of three dimensional human epidermis models. After a post-incubation of 42 hours, a cell viability test was performed.
Investigations performed were in conformance with the EC-method B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test" and the draft OECD Guideline "In vitro Skin irritation: Reconstructed Human Epidermis (RhE) Test Method".
The mean percentage viability of the treated skin discs was 78.4 % which is above the threshold of 50 % for classification. According to the results of this study and the Directive 2001/59/EC, sodium phenoxyacetate is considered to be non-irritant to skin.
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