D-Glucitol, 1-deoxy-1-(formylamino)-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Mar 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well reported GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only four strains investigated (not TA 102)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-deoxy-1-formamido-D-glucitol

EC Number:

618-251-5

Cas Number:

89182-60-5

Molecular formula:

C7 H15 N O6

IUPAC Name:

1-deoxy-1-formamido-D-glucitol

Details on test material:

N-Formylaminosorbit, white powder, Batch: Ansatz 1/89, content 98.1%

Method

Target gene:

histidin gene locus

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

N-Formylaminosorbit: 8-5000 µg/plate
Sodium-azide: 10 µg/plate (TA 1535, without S9)
Nitrofurantoin: 0.2 µg/plate (TA 100, without S9)
4-Nitro-1,2-phenylene diamine: 10 µg/plate (TA 1537, without S9), 0.5 µg/plate (TA 98, without S9)
2-Aminoanthracene: 3 µg/plate (with S9)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

Remarks:

No solvent control was used since sufficient evidence was available in the literature and from testing laboratory experience, indicating that the solvent used had no influence on the spontaneous mutant counts of the used strains.

Positive controls:

yes

Positive control substance:

other: Sodium-azide (without S9), Nitrofurantoin (without S9), 4-Nitro-1,2-phenylene diamine (without S9), 2-Aminoanthracene (with S9)

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

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

Doses up to and including 5000 µg/plate did not cause any bacteriotoxic effects.

No evidence of mutagenic activity of N-Formylaminosorbit was seen with and without S9 mix.

Applicant's summary and conclusion

Executive summary:

N-Formylaminosorbit was investigated using the Salmonella/microsome test for point-mutagenic effects in doses up to and including 5000 µg/plate on the four histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537 and TA 98. Doses up to and including 5000 μg/plate did not cause any bacteriotoxic effects.

No biologically relevant increase in the mutant count in comparison with the negative controls were observed without and with S9 mix. Therefore, no evidence of mutagenic activity of N-Formylaminosorbit was seen.