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Key value for chemical safety assessment

Additional information

The mutagenic potential of 4-Chlor-PMA HCl (technical grade, not purified) was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Nern, 2013). Doses up to and including 500 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strain-specific bacteriotoxic effect. This range could be used up to 5000 µg per plate for assessment purposes, strain specifically. Substance precipitation did not occur. Evidence of mutagenic activity of 4-Chlor-PMA HCl was seen. On Salmonella typhimurium TA 1537, TA 98 and TA 102, a biologically relevant increase was found in the mutant count compared to the corresponding solvent control. The lowest reproducible effective dose was 160 µg per plate for TA 1537 and TA 98 as well as 1600 µg per plate for TA 102. The Salmonella/microsome test thus showed the non-purified test item to have a mutagenic effect.

In a further study the mutagenic potential of the purified test item 4-Chlor-PMA HCl was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Nern, 2014). Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects or precipitations. Evidence of mutagenic activity of 4-Chlor-PMA HCl was not seen. No biologically relevant increase in the mutant count compared to the corresponding solvent control was observed in any of the strains tested, without and with S9 mix. Therefore, the purified test item was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.


Justification for selection of genetic toxicity endpoint
No study was selected since two reliable studies with different test item qualities and different test results are available.

Short description of key information:
Salmonella/microsome test (Ames test): positive with strains TA 1537, TA 102 (-/+ S9 mix) and TA 98 (- S9 mix) using non-purified test substance as well as negative with all strains (-/+ S9 mix) using purified test substance.

Endpoint Conclusion:

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.