Iron digluconate

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:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Missing S. typhimurium strains TA98, TA100, and TA102 or E. coli strain WP2 uvrA; use of only 1 (in plate) and 2 (in suspension) concentrations instead of recommended 5.

GLP compliance:

no

Remarks:

Study predates GLP

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

D-glucono-1,5-lactone

EC Number:

202-016-5

EC Name:

D-glucono-1,5-lactone

Cas Number:

90-80-2

Molecular formula:

C6H10O6

IUPAC Name:

3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-one (non-preferred name)

Constituent 2

Reference substance name:

Glucono-delta-lactone

IUPAC Name:

Glucono-delta-lactone

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1537

Additional strain / cell type characteristics:

not applicable

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Lung, liver, and testes homogenates from adult male mice, rats, and monkeys

Test concentrations with justification for top dose:

0.50% (plate method) and 0.25% or 0.50% (suspension method)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Saline or <10% DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

2-nitrofluorene

N-dimethylnitrosamine

ethylmethanesulphonate

other: Quinacrine Mustard

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

other: For plate tests, it is not clear if the vehicle controls were valid since no numerical results were reported. For suspension tests, vehicle controls appear to be valid.

Untreated negative controls validity:

not applicable

Positive controls validity:

other: For plate tests, it is not clear if the positive controls were valid since no numerical results were reported. For suspension tests, some of the positive control results do not appear to be valid.

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

other: For plate tests, it is not clear if the vehicle controls were valid since no numerical results were reported. For suspension tests, vehicle controls appear to be valid.

Untreated negative controls validity:

not applicable

Positive controls validity:

other: For plate tests, it is not clear if the positive controls were valid since no numerical results were reported. For suspension tests, some of the positive control results do not appear to be valid.

Test results 3

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

other: For plate tests, it is not clear if the vehicle controls were valid since no numerical results were reported. For suspension tests, vehicle controls appear to be valid.

Untreated negative controls validity:

not applicable

Positive controls validity:

other: For plate tests, it is not clear if the positive controls were valid since no numerical results were reported. For suspension tests, some of the positive control results do not appear to be 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

Glucono-delta-lactone, was negative both with or without metabolic activaton. However, some of the positive controls did not appear to be valid.

Executive summary:

Compound FDA 71 -72, glucono-delta-lactone, was negative both with or without metabolic activaton. However, some of the positive controls did not appear to be valid.