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Key value for chemical safety assessment

Additional information

Data for assessing the mutagenicity of anthracene oil < 50 ppm BaP (AOL) is available from one mutagenicity tests with AOL. In addition, data from three assays with Creosote will be used in the hazard assessment based on following reasons.

Anthracene oil < 50 ppm BaP and creosote are closely related tar oils. They are produced in a similar process (fractionated distillation of coal tar using overlapping conditions). Consequently, composition of both substances is similar. Major components are mid-range PAH (naphthalene to pyrene). Individual differences in distillation conditions and in starting material may cause gradual variation in qualitative and quantitative composition. But the nature of constituents and the individual components coincide (PAH), and the percentage of single substances is of the same magnitude. Mutagenic effects of both substances will arise from the PAH present and they are considered to be approximately the same for both substances. Thus, creosote can be used as supporting substance for evaluation of the mutagenicity of anthracene oil < 50 ppm BaP.

Mutagenicity data for anthracene oil < 50 ppm BaP itself is available only from a bacterial reverse mutation assay (Ames test). In this test, five different strains of S. typhimurium were tested with and without metabolic activation. Only in one strain (TA 100) a weak mutagenic response was observed with metabolic activation of the test substance.

With creosote, two in vitro mutagenicity tests (mammalian cell gene mutation assay and mammalian chromosome aberration test) and one in vivo genotoxicity study (in vivo mouse micronucleus assay) have been performed. The gene mutation assay showed a positive response in mouse lymphoma cells, while the chromosome aberration test with human lymphocytes proved negative. In addition, the in vivo mouse micronucleus assay did also produce only a negative test result.

Taking into account the combined evidence of all the tests performed, the overall mutagenicity of anthracene oil < 50 ppm BaP is evaluated negative. In two in vitro standard assays, only a weak mutagenic potential was observed. In two other tests including an in vivo mouse micronucleus assay, test results were negative not confirming an in vivo mutagenic potency of the test substance.


Short description of key information:
For anthracene oil containing less than 50 ppm of BaP, weakly mutagenic potential may be observed in vitro:
An Ames test in the presence of metabolising enzymes was positive only in TA 100 at cytotoxic concentrations;
A mouse-lymphoma assay (MLA, OECD 476) was weakly positive for the closely structure-related tar oil creosote;
A cytogenetic assay (chromosomal aberration, OECD 473) came out negative for the very same tar oil.

An in-vivo micronucleus test in mice using creosote gave no evidence of a mutagenic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The mutagenic potential eventually detected in in-vitro standard assays conducted with tar oils containing BaP levels of =< 50 ppm has not been confirmed in an in vivo mammalian erythrocyte micronucleus assay.

Anthracene oil (BaP =< 50 ppm) is supposed to reflect similar mutagenic properties.

Thus classification according to Regulation (EC) No 1272/2008 or Directive (EU) 67/548/EEC is not required.