Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acute toxicity :

Summary of the results of the tests performed :

It must be kept in mind that all tests were carried on with ground product of less than 100 microns diameter. The usual average content in the commercial substance is only less than 15% in weight. The results were as followed :

LC0 (Fish : Oncorrhynchus mykiss) /96h > 100 mg/l for Ciment Fondu®

EC50 (Daphnia : Daphnia magna) /48h = 6.6 mg/l for Ciment Fondu®

EC50 (Algae :Pseudokirchneriella subcapitata)/72h (cells density) = 4.5 mg/l for Ciment Fondu®

In the algae toxicity study, the results obtained show that the growth rate in the 5.6 mg/Ltest concentration was significantly lower than in the control during the 0 - 24 hour period.

In the 24 - 48 hour period there was no significant difference from the control in any test concentration and in the 48 -72 hour period the 5.6 mg/Ltest concentration had a significantly higher growth rate than the control.

This data suggests that the substance exert a flash toxicity at 5.6 mg/L in the algae when introduced in the water. An important reduction of the cell density is recorded at 24hours. Then the growth rate of the survival algae is similar to the control at 48h and a little more important at 72h . This data suggests that the substance has been inactivated and does not exert any toxicity after 24 h.

Furthermore; the microscopic observations, made at test end, showed that for the control and all test concentrations, the cells appeared normal.

Long term toxicity :

No long term study was performed with the substance.

The substance is a ceramic . In contact with water the substance is hardening within minutes integrating most of the soluble fraction into the solid formed. Nevertheless to assess the toxicity of the substance, the worst case scenario for solubility has been applied:

In the absence of organic matter, Al3+is the predominant aluminium species at low pH (less than 5.5). As pH increases above 5.5, aluminium-hydroxide complexes formed by hydrolysis become increasingly important and dominate aqueous aluminium speciation . Al3+, depending on the composition of the medium and pH, may form Al(OH)3 or AlCl or AlNO3 or AlSO4. According to the long term solubility calculation:

-         At long term, if we consider the substance as a 100% CaAl2O4component:

o  1mg of ground substance if completely dissolved will provide 0.341mg of total Aluminium (34.1%) until Al(OH)3saturation.

Knowing that maximum CaAl2O4content is 70% , the ratio between substance and Aluminium equivalent Al(OH)3 is 0.7 x 0.341 = 0,238. or 1g of Aluminium equivalent Al(OH)3 is 4.2g of substance.

A read-across was made with all relevant soluble aluminium salts and and Ciment Fondu®. An assessement factor of 4.2 is applied for the calculation of the substance long term NOEC.

Long term fish toxicity : NOEC (AlCl3) / 7 days= 15 mg/L

Long term invertebrates toxicity : NOEC (AlCl3) / 6 days= 0.34 - 1.02 mg/L

Short term algae toxicity : NOEC (Ciment Fondu®) /72h = 3.2 mg/L

These data could lead to considered that the calculated NOEC for the substance could be between 1.43 and 4.28 mg/l (based on the NOEC of AlCl3).

Hence, it is reasonnably assumed that the NOEC for the substance registered in this dossier is greater than 1 mg/l