Registration Dossier

Administrative data

Description of key information

The test substances, Fluidized Bed Combustion (FBC) Bottom Ash and Fluidized Bed Combustion (FBC) Fly Ash, were tested for acute inhalation toxicity using the OECD Guidelines for Testing Chemicals (1981) No.403 „Acute Inhalation Toxicity“ referenced as Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008 and for acute oral toxicity using the Method B.1 tris „Acute Oral Toxicity-Acute Toxic Class Method“ Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
No data for acute dermal toxicity are available.
The values LD50 and LC50 are same for Fluidized Bed Combustion (FBC) Bottom Ash and for Fluidized Bed Combustion (FBC) Fly Ash: LD50 > 2000 mg/kg and LC50 > 5.38 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 380 mg/m³

Additional information

The systemic effect (disappeared shortly after administration) was described after single oral administration of the substance Fluidized Bed Combustion (FBC) Fly Ash to rats. It is not possible to confirm absorption of the test substance from digestive tract. The clinical symptoms could related with total reaction of organism to application of the test substance.   

In inhalation study the systemic effects were observed and animals recovered slowly (Fly Ash). It is not possible to confirm absorption of the test substance from respiration system, observed symptoms can bear on local effects in respiratory system.

The substance (FBC) Bottom Ash contains higher concentration of Calcium oxide: in (FBC) Fly Ash the total concentration of Calcium oxide is about 19% and in (FBC) Bottom Ash it is about 36%. 

The negative effect of higher concentration of Calcium oxide was expressed in results of inhalation study: clinical symptoms of irritation of respiratory tract were more marked and animals recovered more slowly after nose exposure to (FBC) Bottom Ash.

Justification for classification or non-classification

Based on the test results and according to the EC criteria for classification for dangerous substances the test substances Fluidized Bed Combustion (FBC) Bottom Ash and Fluidized Bed Combustion (FBC) Fly Ash did not fall into any quoted categories of toxicity for oral and inhalation route of exposure.