6-sec-butylquinoline

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Structurally source and target substances are comparable, regarding the physico-chemical properties, source material seems to be likely more systemically bioavailable than 6-SBQ (target material). From a toxicity point of view, SBQ (source material) would therefore be expected to represent ‘worst-case’-scenarios.

Reason / purpose for cross-reference:

read-across source

Specific details on test material used for the study:

The source material is Butyl Quinoline Secondary. It is a mixure of 2 isomers.
The two isomers are 6-Sec-butylquinoline (91.1%) and 8-sec-butylquinoline (8.7%). The target substance is 6-Sec-butylquinoline.

Key result

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate

RANGE-FINDING/SCREENING STUDIES:
- In all strains toxicity was observed at either 158 or 500 µg/plate and above, both in the absence and presence of S9 in the dose range finder.

COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In all strains toxicity was observed at the higher doses (at >= 250 µg/plate), both in the absence and/or presence of S9

Remarks on result:

other:

Remarks:

No correction between the experimental result of tested material and the read-across target material.

Conclusions:

In a Salmonella typhimurium reverse mutation assay performed according to OECD 471 (1997) with the source material, no mutagenic effect was observed. Structurally source and target substances are comparable, regarding the physico-chemical properties, source material seems to be likely more systemically bioavailable than 6-SBQ (target material). From a toxicity point of view, SBQ (source material) would therefore be expected to represent ‘worst-case’-scenarios. The target material (6-sec-butylquinoline) can also be considered as not mutagenic in the same conditions.

Executive summary:

The mutagenic activity of the substance source was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed in two independent experiments, at first a direct plate assay was performed and secondly a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in all strains (>=250 ug/pl). Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay. As source and target material are comparable, the same conclusion may be applicable for the target material 6 -sec-butylquinoline.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available