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EC number: 200-609-3 | CAS number: 65-45-2
No relevant information on fertility was identified in the literature search.
Only one reproductive toxicology study was identified in the literature (Wright 1967). Reproductive parameters are not measured in detail (44%-45% of all females across all dose groups and generations did not litter. However, no dose response and no further data given). The number of females to litter (%) and pups born that were raised to weaning age (%) were reduced in all treated groups with no dose response. However, the dams were dosed at maternally toxic doses and parental survival time was significantly reduced compared with controls for all dose groups. As was percentage of pups raised to weaning age. A NOAEL was not derived. This study is therefore not adequate for assessing reproductive toxicity of salicylamide.
The results of the literature search are inconclusive for the developmental toxicity potential of salicylamide.
Many of the studies identified within the literature review start with the assumption that salicylamide is a teratogen, based on the results of early work conducted in hamster embryos in 1964. This study has many shortcomings and cannot be used for assessing the teratogenic potential of salicylamide. The subsequent studies also have substantial technical and scientific shortcomings (All achieved a Klimisch rating of 3), and the focus of most of the studies was investigating the effect of salicylamide on the incorporation of sulfate into foetal glycosaminoglycans. No study identified a NOAEL for developmental toxicity for salicylamide and none are regarded as adequate for use in risk assessment and classification and labelling.
The publicly available studies are regarded as not adequate for use in classifcation and labelling.
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