4-O-α-D-glucopyranosyl-D-glucitol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

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 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

GLP compliance:

no

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Syrups, corn, hydrogenated

EC Number:

270-337-8

EC Name:

Syrups, corn, hydrogenated

Cas Number:

68425-17-2

Molecular formula:

UVCB substance: not applicable

IUPAC Name:

Syrups, hydrolyzed starch, hydrogenated

Details on test material:

- Name of test material (as cited in study report): Lycasin
- Physical state: Clear, colourless, viscous liquid
- Lot/batch No.: Compound was assigned Laboratory Number 258
- Storage condition of test material: At room temperature
- Stability under test conditions: Assumed to be stable under the conditions of the study

Method

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Test concentrations with justification for top dose:

Toxicity test = 4, 12, 37, 110, 330, or 1000 µg/mL (± S9)
Mouse lymphoma (Test 1) = 61, 91, 135, 202, 301, 449, 670, or 1000 µg/mL (± S9)
Mouse lymphoma (Test 2) = 27, 41, 61, 91, 135, 202, 301, or 449 µg/mL (± S9)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

- cell culture medium

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: - Ethylmethane sulfonate (- S9) and 3-methyl cholanthrene (+ S9)

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

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'.

Any other information on results incl. tables

No dose-dependent increases in the mutation frequencies were noted in either mouse lymphoma test.

Applicant's summary and conclusion

Conclusions:

No cytotoxicity and no increases in the mutant frequency were noted at any concentration either in the absence or presence of metabolic activation.

Executive summary:

According to the study authors, Lycasin, when tested at 8 concentrations ranging from 27 to 1000 µg/mL in the presence and absence of metabolic activation, was equivocal in the mouse lymphoma test. However, as no dose-dependent increases in the mutation frequencies were noted and the laboratory's criteria for determining a positive response were not met, it is thought that the result of the mouse lymphoma test is negative.