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Diss Factsheets
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EC number: 444-900-5 | CAS number: 49667-22-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
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.