Reaction product of propylene and synthesis gas in a hydroformylation being a sidestream during purification

Endpoint summary

Additional information

As required under REACH for a transported isolated intermediate, a bacterial reverse mutation assay is available to assess the mutagenic potential of Zorgol 48 (1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues).

 

In a reverse gene mutation test in bacteria, (Ames assay) under GLP conditions, five strains of S. typhimurium (TA 97a, TA 98, TA 100, TA 102, and TA 1535) were exposed to Zorgol 48 (vehicle ethanol) in two experiments (plate incorporation and pre-incubation assay) at concentrations ranging from 50 to 5000 µg/plate in the presence and absence of mammalian metabolic activation (liver S9-mix from induced rats).

 

Up to a limit concentration of 5000 µg/plate, no cytotoxicity was observed. Zorgol 48 did not increase the number of revertants in any of the tester strains neither with nor without metabolic activation. There was no evidence of induced mutant colonies over background. The test item was found not to be mutagenic under test conditions (Paulus/Laus, 2010).

Short description of key information:
In an bacterial reverse mutation assay (Ames test), Zorgol 48 did not show any mutagenic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the result of the bacterial reverse mutation test, Zorgo 48 (1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues) has not to be classified as mutagenic or germ cell mutagen according to Directive 67/548/EEC or Regulation (EC) No 1272/2008, respectively.