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EC number: 200-463-0 | CAS number: 60-23-1
A DEREK assessment, DPRA assay and KeratinoSensTMassay were performed in accordance withSection 8.3 of Annex VII of Regulation (EC) No 1907/2006 as amended in Commission Regulation (EU) 2016/1688 of 20 September 2016 and the strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a.
The DEREK assessment yielded an alert for skin sensitization based on the presence of the thiol group and predicted an EC3 of 1.3% (LLNA). Mercaptamine was considered to be positive in the DPRA and classified in the “high reactivity class”. The KeratinoSensTM assay also yielded a positive result. Based on the positive in chemico/in vitro skin sensitization tests Mercaptamine should be classified as a skin sensitizer. DPRA data indicate a high protein reactivity and QSAR modelling predicted an EC3 of 1.3% (LLNA). Based on this information, it is considered justified to classify Mercaptamine as skin sensitiser Cat. 1A.
An overview of the individual results of the cysteine and lysine reactivity assays as well as the mean of the SPCC and SPCL depletion are presented in the table below. In the cysteine reactivity assay the test item showed 92.6% SPCC depletion while in the lysine reactivity assay the test item showed 3.7% SPCL depletion. The mean of the SPCC and SPCL depletion was 48.2% and as a result the test item was positive in the DPRA and was classified in the “high reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model. Therefore, Mercaptamine was considered to be positive in the DPRA.
Table 6: SPCC and SPCL Depletion, DPRA Prediction and Reactivity Classification for Mercaptamine
Mean of SPCC and SPCL depletion
DPRA prediction and
Cysteine 1:10 / Lysine 1:50 prediction model
Positive: High reactivity
SD = Standard Deviation.
Table 1: Overview Luminescence Induction and Cell Viability of Mercaptamine in Experiment 1 and 2
Exp 1 luminescence
Exp 1 viability (%)
Exp 2 luminescence
Exp 2 viability (%)
*** p<0.001 Student’s t test
Table 2: Overview Luminescence Induction and Cell Viability Positive Control EDMG in Experiment 1 and 2
Table 3: Overview EC1.5, Imax, IC30and IC50Values
Test item Experiment 1
Test item Experiment 2
Pos Control Experiment 1
Pos Control Experiment 2
NA = Not applicable
In conclusion, taking all existing and relevant data into account, there is sufficient information to meet the information requirement of Section 8.3 of Annex VII and Mercaptamine should be classified as skin sensitiser Cat 1A in accordance with the CLP regulation (EC1272/2008,as amended).
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