C12-14 (even numbered) alkyl glycosides, oligomeric and C12-14 (even numbered) alkyl glycosides, oligomeric, carboxymethyl ethers, sodium salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Klimisch criteria

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Method

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Exp I:
4h, without S9: 9.4, 18.8, 37.5, 75, 150, 300 microg/L
4 h, with S9: 37.5, 75, 150, 300, 600, 1200 microg/L
Exp II:
24 h, without S9: 7, 14.1, 28.1, 56.3, 112.5, 225 microg/L
4 h, with S9: 112.5, 225, 450, 900 microg/L

Vehicle / solvent:

water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

ethylmethanesulphonate

Details on test system and experimental conditions:

according to guideline

Evaluation criteria:

according to guideline

Statistics:

according to guideline

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Under the experimental conditions described, D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, carboxymethyl ethers, sodium salts is considered not to be a chromosome-damaging (clastogenic) substance or to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells.

Executive summary:

D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, carboxymethyl ethers, sodium salts were investigated for clastogenic activity or for the induction of chromosome aberrations accoring to OECD guideline 476 under GLP conditions. Two indpendant experiments were performed. The individual test concentrations with and without metabolic activation are described above.

Cytotoxicity indicated by clearly reduced relative increase in cell count (RICC) proliferation index and/or low quality of the slides was observed in all experimental parts either in the absence or in the presence of S9 mix. No statistically significant increase in the number of micronucleated cells was observed compared to the concurrent negative controls. All values were close to the concurrent negative controls and within our historical negative control data range. Thus, under the experimental conditions described, D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, carboxymethyl ethers, sodium salts is considered not to be a chromosome-damaging (clastogenic) substance or to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells.