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Administrative data

Description of key information

Fluidized Bed Combustion (FBC) Fly Ash and Fluidized Bed Combustion (FBC) Bottom Ash were tested for the assessment of eye irrtation/corrosion effects using:
- human corneal model EpiOcular(TM): negative
- albino rabbit (Method B.5 Acute Toxicity: Eye irritation/corrosion): negative
Fluidized Bed Combustion (FBC) Fly Ash and Fluidized Bed Combustion (FBC) Bottom Ash were tested for the assessment of skin irrtation/corrosion effects using:
- human epidermal model EpiDerm(TM): negative results
- albino rabbit (Method B.4 Acute Toxicity: Dermal irritation/corrosion): negative results
All tests were performed in accordance with GLP principles.
The test substances were not corrosive in EpiDermal(TM) in test "In vitro Skin Corrosion". If not corrosive, the irritating potential was determined. The test substances were not irritating in EpiDermal(TM) in test "In vitro Skin Irritation". In the test "Acute Toxicity: Dermal Corrosion/Irritation" no evidence of a corrosive effect or symptoms of irritation were observed on skin.
The test substances were moderately irritating in EpiOcular(TM) Model.
Examination of eye irritation after single application demonstrated, that the test substances are irritating for eye of rabbit; the changes observed were reversible.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

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%. Size of individual particles of (FBC) Ashes is quite different – structure of (FBC) Fly Ash is rather fine whereas structure of (FBC) Bottom Ash is coarse. In (FBC) Fly Ash more than 85% particles are smaller than 0.063 mm and in (FBC) Bottom Ash more than 90% particles are smaller than 1.00 mm but no of its particles are smaller than 0.063 mm.

The influence of different chemical composition and different size of particles of Ashes manifested especially in results of eye irritation/corrossion study. Intensity of eye irritation was higher in (FBC) Bottom Ash: clinical symptoms of irritation were more marked and animals recovered more slowly after application.

After skin single application systemic toxic effects were not detected – the test substance does not penetrate through the skin. Although the substance contains relatively high quantity of Calcium oxide it is not irritant for skin.

Justification for classification or non-classification

Based on these results and according to the EC criteria for classification for dangerous substances (Council Directive 67/548/EEC, Annex VI, part 3.2.6.1.), the test substance does not have to be classified for skin irritation.

Based on the test results and according to the EC criteria for classification of dangerous substances the test substances do not have to be classified for eye irritation/corrosion.