Registration Dossier
Registration Dossier
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EC number: 701-289-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
According to the REACh Regulation Annex IX, Section 8.7, Column 2, reproductive toxicity studies do not need to be conducted if the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure and there is no or no significant human exposure.
The oral biovailability of Al metal is negligible, the acute oral toxicity study with aluminium skimmings have shown no effects and there is no systemic exposure to Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2) from its intended uses. The criteria for not conducting reproductive studies are thus fulfilled.
A number of reproductive toxicity studies have been published using soluble Al salts. The weight of this evidence demonstrates that Al(III) has no specific effects on reproduction; no effects were noted at doses that did not already produce general toxicity. For aluminium skimmings, the systemic doses that can be reached by any route of exposure will be orders of magnitude below those achieved by administration of Al(III) salts, especially if Al(III) is dosed via parenteral routes. It can be safely assumed that Al metal or aluminium skimmings do no possess a potential for reproductive toxicity.
Short description of key information:
Aluminium skimmings are considered to have no effects on fertility.
Effects on developmental toxicity
Description of key information
Aluminium skimmings are considered to have no effects on intrauterine development.
Additional information
Due to its very low bioavailability, aluminium skimmings cannot affect intrauterine development. A number of studies involving developmental endpoints have been published using soluble Al salts. The weight of this evidence demonstrates that Al(III) has no specific effects on development; no effects were noted at doses that did not already produce maternal toxicity. For aluminium skimmings, the systemic doses that can be reached by any route of exposure will be orders of magnitude below those achieved by administration of Al(III) salts, especially if Al (III) is dosed via parenteral routes. It can be safely assumed that Al mewtal or aluminium skimmings do no possess a potential for developmental toxicity.
Justification for classification or non-classification
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.
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.
