Registration Dossier

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

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 4.8).

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 systemic toxicity.

Inhalation :

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 inhalation

Justification for classification or non-classification

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 physico-chemical characteristics