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EC number: 932-420-3
CAS number: -
Based on the test results for the oral acute toxicity of Ciment fondu® and the read-accross with aluminium hydroxide, it is considered that the substance does not present acute hazard by inhalation, oral and dermal routes.
According to the available documents on the solubility of the aluminate
cements, the aluminium hydroxide is the only available substance in
aqueous medium and is the substance that can potentially lead to an
adverse effect. (see chap 4.8)
Dermal route :
In the analytical data on the solubility of the aluminate cements in
water, aluminium hydroxide is the main dissolved substance (see chap
Furthermore, aluminium does not cross the dermal barrier and does not
reach the systemic circulation as it is observed when aluminium
chlrorhydrate is applied on the skin (see chap 7.1.2).
Since the substance has no systemic toxicity at the maximum dose by oral
route and since aluminium is not absorbed through the skin, it is
reasonably assumed that the dermal route is of no concern for acute
Inhalation route is
indeed an appropriate route of exposure since the substance is an
aggregate containing an alveolar fraction
The substance has no systemic toxicity as it is shown in the acute oral
toxicological assay on Ciment Fondu® at doses up to 2000 mg/kg.
Moreover, in aqueous media the soluble fraction of the substance is
mainly composed by aluminium hydroxide, depending on pH, and calcium
hydroxide. It is assumed that the extent at which the soluble fraction
of the substance will be absorbed through the alveoli would be quite
similar to those observed in the oral route. In addition as a weight of
evidence one inhalation study report on alumina where no effects by
inhalation was observed may be used.
It is concluded that the subtance would have no lethal effect by
No classification for
acute toxicity is recommended according to DSD and CLP classification
based on the test results for the oral route on the substance itself and
the read-across from aluminium hydroxide with regard to the
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.
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