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EC number: 274-354-1 | CAS number: 70161-18-1
The prediction of the skin sensitising potential of acid orange 94 refined was performed with BIOVIA Discovery Studio (TOPKAT) 4.5, VEGA NIC 1.1.4 (SAESAR), OECD QSAR Toolbox 4.2, Toxtree 3.1.0 and DEREK Nexus 6.0.1. In addition, results from the Danish QSAR Database were also considered in this assessment. The TOPKAT model for skin sensitisation was extended by including 63 data from the Envigo database.
With two positive and two negative predictions and all considered not to be reliable or to be of low reliability, there are no arguments for a weight of evidence. The QSAR predictions are therefore not considered conclusive and In Vitro testing of acid orange 94 refined is recommended provided that the compound is within the applicability of the respective In Vitro tests.
In vitroSkin Sensitisation Test - Human Cell Line Activation Test (h-CLAT)
This in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP) of Acid Orange 94 Refined dissolved in 0.2% (v/v) DMSO in culture medium when administered to THP-1 cells for 24 ± 0.5 hours. The highest test item concentration for the main experiment (h-CLAT) of Acid Orange 94 Refined was previously determined by two cytotoxicity tests.
This study was performed in accordance to OECD Guidelines for the Testing of Chemicals: OECD 442E; In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation. Annex I: In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT), June 2018, in accordance with GLP.
The test item Acid Orange 94 Refined with a log Pow of -1.79 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).
In chemicoSkin Sensitisation: Direct Peptide Reactivity Assay (DPRA),
The purpose of this study (based on the OECD guideline for the testing of chemicals, hi cli ernico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA), OECD/OCDE document TG 442C) was to assess the reactivity and sensitizing potential of Acid Orange 94 Refined.
Solutions of Acid Orange 94 Refined were successfully analyzed by the validated DPRA analytical method (analytical method FIA/M101/15) in both the Cysteine and Lysine containing synthetic peptides. With overall mean peptide depletion (reactivity) of 76.0% in the presence of the test item, Acid Orange 94 Refined is highly reactive and hence is predicted by DPRA as positive and therefore is likely to be a potential skin sensitizer based on this assay.
With two positive and two negative predictions and all considered not to be reliable or to be of low reliability, there are no arguments for a weight of evidence. The QSAR predicitions are therefore not considered conclusive and In Vitro testing of acid orange 94 refined is recommended provided that the compound is within the appicability of the respective In Vitro tests.
As the exclusion criteria for testing according to ECHA have not been met and (Q)SAR predications for skin sensitisation potential are not considered conclusive, In Vitro testing of acid orange 94 refined should be performed.
Cytotoxic effects were not observed following incubation with the test item up to the highest tested concentration (334 μg/mL). Due to the lack of cytotoxicity, a CV75 value could not be calculated. Therefore, the highest soluble test item concentration 334 μg/mL was used as highest test item concentration for the h-CLAT runs.
The following concentrations of the test item were tested in the main experiments (h-CLAT):
93, 112, 134, 161, 193, 232, 278 and 334 μg/mL
The test item with a log Pow of -1.79 was tested in 2 independent runs. The RFI of CD54 was greater than 200% in all concentrations of both independent runs. Therefore the h-CLAT prediction is considered positive for the test item in this h-CLAT.
In the DMSO control, RFI values compared to the medium control of both CD54 and CD86 did not exceed the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%). The RFI values of the positive controls (DNCB) for CD54 and CD86 exceeded the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%) and the cell viability was >50%. For details see Annex 1 and 2. All acceptance criteria met for the cytotoxicity test and the h-CLAT method.
The depletion of peptide in the presence of Acid Orange 94 Refined was:
Mean peak area of peptide with test item(µV.sec)
Mean peptide depletion by Acid Orange 94 Refined (%)
Control B: 891830 (n=6)Control C: 870820 (n=3)
Control B: 788030 (n=6)Control C: 774210 (n=3)
Applying the following reactivity prediction depletion model (below), reactivity of Acid Orange 94 Refined is classed as “high” and the DPRA prediction is therefore positive and is therefore predicted to be a potential skin sensitizer.
There were no co-elution peaks in either the Cysteine or Lysine assay.
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