Pentyl D-glucoside

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Mutagenicity (OECD 471): negative with and without metabolic activation in tester strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA

Read-across from structural analogue source substance D-Glucopyranose, oligomers, hexyl glycosides (CAS 54549-24-5)

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Please refer to analogue justification report provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Key result

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Source, 54549-24-5, Safepharm Laboratories, 1998b

Conclusions:

Interpretation of results: negative

Executive summary:

The potential of gene mutations in bacteria of the target substance is estimated based on an adequate and reliable in vitro gene mutation study in bacteria of a structural analogue source substances. Experiments have been performed both in the presence as well as in the absence of metabolic activation. All results obtained are negative, i.e. no gene mutation in bacteria was observed. Based on read-across, no hazard with regard to gene mutation in bacteria is identified for the target substance. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in gene mutation in bacteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on a reliable study performed with an adequate analogue substance, D-Glucopyranose, oligomeric, pentyl glycosides (CAS 100231-63-8) is not expected to cause gene mutation in bacteria.

Justification for classification or non-classification

The available data on gene mutation in bacteria from an adequate analogue substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Based on read-across, D-Glucopyranose, oligomeric, pentyl glycosides (CAS 100231-63-8) is also considered not to cause mutations in bacteria. The data provide not sufficient evidence that would imply any classification and labelling with respect to mutagenicity/genotoxicity. However, as no information regarding gene mutation in mammalian cells and cytogenicity or chromosome aberration in mammalian cells are available, the overall conclusion for classification regarding mutagenicity/genotoxicity is ‘data lacking’.