Registration Dossier
Registration Dossier
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EC number: 215-478-8 | CAS number: 1327-43-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Not required.
Additional information
Within the scope of a comprehensive and valid testing programme, the test item sodium silicoaluminate was examined for embryotoxic and developmental effects during the gestation phase in various animals species (rat, mouse, rabbit and hamster) at an oral dose of 1600 mg/kg bw/day. There were no significant signs of maternal or embryotoxic/developmental effects. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the frequencies occuring spontaneously in the control animals (FDA 1973).
Short description of key information:
No data.
Effects on developmental toxicity
Description of key information
NOAEL (maternal toxicity) ≥ 1600 mg/kg bw/day (for rat, mouse, rabbit and hamster) (FDA 1973)
NOAEL (teratogenicity) ≥ 1600 mg/kg bw/day (for rat, mouse, rabbit and hamster) (FDA 1973)
Additional information
Within the scope of a comprehensive and valid testing programme, the test item sodium silicoaluminate was examined for embryotoxic and developmental effects during the gestation phase in various animals species (rat, mouse, rabbit and hamster) at an oral dose of 1600 mg/kg bw/day. There were no significant signs of maternal or embryotoxic/developmental effects. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the frequencies occuring spontaneously in the control animals (FDA 1973).
Toxicity to reproduction: other studies
Additional information
Not required.
Justification for classification or non-classification
The experimental data on intra-uterine development produced in rat, mouse, rabbit and hamster suggest that there is no potential for adverse effects on embryonal/foetal development arising from exposure to synthetic amorphous silica.
Therefore, it is not expected that silicic acid, aluminium magnesium salt produces adverse effects on the reproductive performance or embryonic/foetal development in experimental animals. No classification is required.
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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