Hexyl D-glucoside

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:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study. Reliability changed from "1" to "2" according to ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)."

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

110615-47-9

Cas Number:

110615-47-9

IUPAC Name:

110615-47-9

Details on test material:

- Name of test material (as cited in the study report): C12/14/16 alkylpolyglucoside
- Physical state: Yellow paste
- Analytical purity: approx. 50%
- Lot/Batch number: 3BQ12
- Storage conditions: room temperature

Method

Target gene:

n.a.

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Details on mammalian cell type (if applicable):

The cell line has a high proliferation rate with a doubling time of approx. 12-18 h in untreated stock cultures and a high plating efficiency of regularly more than 50%. The cells have a stable karyotype with a modal chromosome number of 22 and a low degree of polyploidy.

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

+ S9 mix:
2, 8, 16 µg/mL

- S9 mix:
10, 40, 80 µg/mL

Vehicle / solvent:

medium

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

medium

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: ethylmethanesulfonate (EMS, -S9); cyclophosphamide (CP, +S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk

DURATION
- Preincubation period: approx. 1 day
- Exposure duration: 4 h
- Fixation time (start of exposure up to fixation or harvest of cells): 7, 20, 28 h

SPINDLE INHIBITOR (cytogenetic assays): 0.4 µg colcemide (2-2.5 h before harvesting)
STAIN (for cytogenetic assays): Giemsa solution
NUMBER OF REPLICATIONS: duplicates

NUMBER OF CELLS EVALUATED: 200 metaphases

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index

Evaluation criteria:

A test substance is classified as mutagenic if a significant, concentration-related increase in the proportion of structural aberrations is induced or a significant positive response for at least one test concentration is found.
A test substance is classified as non—mutagenic in this test system, if neither a significant concentration—related increase in the proportion of structural chromosomal aberrations nor a significant positive response at any of the analysed test substance concentrations is detected.
If required, a statistical analysis, e.g. the chi-square test of the test results can be performed. However, both statistical and biological significance should be considered together.

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 examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
In the experiment on plating efficiency, strong toxic effects were noticed at 5 µg/mL and higher without metabolic activation and above 100 µg/mL with S9 mix.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the cytogenetic experiment, the test substance was applied up to 16 µg/mL without and 160 µg/mL with metabolic activation. In the experiment without S9 mix no substantial reduction of the Mitotic Index (MI) was observed at the highest concentration. With metabolic activation, there was no cellular growth to be detected at 160 µg/mL at all three fixation times, and nearly no mitoses to be detected at 80 µg/mL 7 h after treatment. No substantial reduction of the MI was determined at 80 µg/mL 20h and 28h after treatment.

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