Registration Dossier
Registration Dossier
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EC number: 200-609-3 | CAS number: 65-45-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No relevant information on fertility was identified in the literature search.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
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.
Effects on developmental toxicity
Description of key information
The results of the literature search are inconclusive for the developmental toxicity potential of salicylamide.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
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.
Justification for classification or non-classification
The publicly available studies are regarded as not adequate for use in classifcation and labelling.
Additional information
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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