Syrups, wheat, hydrolyzed starch

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation for a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

yes

Remarks:

- only 100 metaphase cells were evaluated per dose.

GLP compliance:

no

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Lycasin® 80/55 is a commercial hydrogenated glucose syrup which consists primarily of maltitol, maltotriitol, sorbitol, and other hydrogenated oligo- and polysaccharides.

IUPAC Name:

Lycasin® 80/55 is a commercial hydrogenated glucose syrup which consists primarily of maltitol, maltotriitol, sorbitol, and other hydrogenated oligo- and polysaccharides.

Details on test material:

- Name of test material (as cited in study report): Lycasin
- Physical state: Clear liquid
- Lot/batch No.: E664-B
- Storage condition of test material: Tightly capped at room temperature

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 mix (further details not provided)

Test concentrations with justification for top dose:

49, 164, 490, 1640, or 4900 µg/mL (± S9)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Distilled, deionized water.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

- Distilled, deionized water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Ethylmethane sulfonate (EMS; - S9) and cyclophosphamide (CP; + S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium.

DURATION
- Exposure duration: 8 hours (- S9) and 2 hours (+ S9) at 37 ± 0.5 ºC.

SPINDLE INHIBITOR (cytogenetic assays): Colcemid.

NUMBER OF REPLICATIONS: Duplicate flasks used; use of an independent repeat was not reported.

NUMBER OF CELLS EVALUATED: 100 metaphase cells/dose level (50 cells/duplicate flask).

Evaluation criteria:

Chromosomal aberrations were characterized as the following:

- chromatid breaks (including fragments and deletions)
- chromosome breaks (including acentric fragments and minutes)
- chromatid and chromosome gaps
- exchanges (rings, dicentrics, quadriradicals, and triradicals)
- cells with 10 aberrations
- pulverized cells.

Statistics:

Chi-square and one-tailed t-test.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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 with metabolic activation
negative without metabolic activation