Registration Dossier
Registration Dossier
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EC number: 444-900-5 | CAS number: 49667-22-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Read-across justification
Genetic toxicity in vitro data on 4-methyl salicylamide (CAS 49667-22-3) is a data requirement for REACH dossiers 1-10 tonnes/year. Since information on this endpoint is lacking for this substance, read-across to the structurally similar substance salicylamide (CAS 65-45-2) is suggested. RAAF scenario 2 is applicable since the hypothesis is based on different compounds having the same type of effect.
The source substance has an additional methyl group in comparison to salicylamide.
Based on the OECD QSAR toolbox profiling application, both substances have a similar profile: both are e.g. considered as low reactive according to DPRA cysteine/lysine peptide depletion and both are weak estrogen receptor binders.
Regarding in vitro mutagenicity (alerts by ISS) no alert was found for both substances.
However, both substances have a H-acceptor-path3-H-acceptor alert (in vivo mutagenicity alerts by ISS) due to the
OH and CONH2 group. This alert explores the possibility that a chemical could potentially interact with DNA and/or proteins via non-covalent binding (Snyder et al. 2006[1]). The methyl group of 4-methyl salicylamide is expected to cause steric hindrance which makes the latter less reactive than salicylamide. This is also reflected in the human health classification of both substances: salicylamide is classified as Acute Toxic Cat. 4 (oral route), while 4-methyl salicylamide is not classified for acute toxicity oral route.
Since salicylamide is expected to be more reactive, the read-across approach from 4-methyl salicylamide to salicylamide can be considered a worst-case approach.
Several in vitro and in vivo genetic toxicity publications of salicylamide are available. These publications are included as endpoint study records. Based on the publications, salicylamide is not considered as genetic toxic. Since salicylamide is expected to be more reactive, it can be concluded that 4-methyl salicylamide is not genetic toxic as well.
[1]Snyder, R. D., Ewing, D. and Hendry, L. B. 2006. DNA intercalative potential of marketed drugs testing positive inin vitrocytogenetics assays.Mutat. Res.609, 47-59.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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.
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