Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no substance specific data available on the skin sensitising potential of ashes (residues), cenospheres.

Ashes (residues), cenospheres and ashes (residues), coal share a common production process as substances derived from coal combustion. Ashes (residues), cenospheres represent a fraction of ashes (residues), coal separated by physical means. Both substances exhibit similarities in physicochemical properties and chemical composition. The main differences consist in a much lower content of water soluble matter and the particle size distribution of ashes (residues), cenospheres.

In terms of hazard assessment, studies available for ashes (residues), coal are therefore taken into account by read-across following an analogue approach, the results of these studies being considered a worst case for ashes (residues), cenospheres.

Ashes (residues) were tested for skin sensitisation potential in a mouse local lymph node assay (LLNA) conducted under GLP conditions. The method was performed with an endpoint different from that described in the original guideline (non radioactive measuring of cell proliferation). The assay was conducted according to EU method B.42 with modifications as described in publications (Ulrich et al., 2001; Ehling et al., 2005a, b).

The contact allergenic potential of Ashes (residues) was evaluated after topical application to female BALB/c mice. Six mice per group were exposed to test and control substances on the dorsum of both ears once a day for 3 consecutive days. Draining lymph nodes were removed 24 hours after the last application. Ashes (residues) were tested as suspensions in DAE 433 (40% dimethylacetamide, 30% acetone, 30% ethanol) at 0.3, 3 and 30% (w/v). The positive control substance dinitrochlorobenzene (DNCB) was tested at 0.5% (w/v) in DAE 433. Ear weight, auricular (ear-draining) lymph node weights and lymph node cell counts were assessed as parameters for lymph node (LN) hyperplasia.

Animals exposed to the test substance showed no pathological skin reactions and no clinical symptoms of intoxication throughout the experiment. There was no difference in body weight gain in all groups compared to the vehicle control. Ashes (residues) did not cause statistically significant increases in LN cell count, LN weight or ear weight at the dose levels tested.

The positive control substance DNCB elicited a reaction pattern with statistically significant increase in LN hyperplasia, which was in congruence with its expected mode of action as a contact allergen.

It was concluded that, under the experimental conditions of the study, Ashes (residues) yielded negative results in the LLNA (Plodíková, 2008).

Based on their physicochemical properties (solid inorganic particles of mostly water insoluble compounds), ashes (residues), cenospheres are not considered to be biologically reactive on the skin leading to the induction of a sensitising reaction. Furthermore, none of the components of ashes (residues), cenospheres is a known skin sensitiser.

Migrated from Short description of key information:
Based on read-across following an analogue approach, ashes (residues), cenospheres are considered to be not sensitising to the skin.

Respiratory sensitisation

Endpoint conclusion
Additional information:

This information is not available.

Justification for classification or non-classification

Based on read-across following an analogue approach, the available data on the skin sensitising potential of ashes (residues), cenospheres is conclusive but not sufficient for classification according to the DSD (67/548/EEC) and GHS (CLP, 1272/2008/EC) criteria for classification and labelling.

There are no data available on the respiratory sensitisation potential. Thus, classification is not possible due to data lacking.