Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-638-5 | CAS number: 2842-44-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Three experiments in the in chemico study DPRA performed on N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) were performed. Experiment 1 was valid, but the mean peptide depletion of both peptides falls in the range of 3 % to 10 %. This means it is a borderline result, close to the threshold used to discriminate between positive and negative results. Therefore, a second run was performed to verify the DPRA prediction. Experiment 2 was invalid for the Cys-peptide assay. For the Lys-peptide assay experiment 2 was valid. The third experiment was valid for the Cys-peptide assay. The mean peptide depletion value calculated with the depletion values of the Lys-peptide of experiment 2 and the Cys-peptide of experiment 3 confirmed the DPRA prediction of the first experiment and lead to an overall negative DPRA prediction. In conclusion, the DPRA prediction is “negative” according to the Cysteine 1:10/Lysine 1:50 prediction model. Thus, under the experimental conditions reported, the test itemN-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) shows no reactivity towards the two model synthetic peptides. Even if the Experiment 1 is a "boderline result" the potency assessment could be assigned to the reactivity class that covers “no or minimal” reactivity. In the second in vitro sudy the test item N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT), was positive in the LuSens assay and is therefore considered to have the potential to activate the Nrf2 transcription factor (sensitizing potential). A statistically significant and reproducible increase in luciferase induction≥1.5 fold in more than two non-cytotoxic consecutive test item concentrations was observed in all experiments. The test item N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT), was positive in the LuSens assay and is therefore considered to have the potential to activate the Nrf2 transcription factor (sensitizing potential). Therfore the substance is classified as skin sesitizer Cat. 1 according to UN GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
