Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate

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:

20 January 1989 - 30 January 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD guidelines and GLP. Devation from the current guideline: With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate

EC Number:

400-660-3

EC Name:

Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate

Cas Number:

111687-36-6

Molecular formula:

Hill formula: C11 H18 Fe N3 O8 CAS formula: C11 H14 Fe N2 O8.H4N

IUPAC Name:

iron(3+) ammonium 2-({3-[bis(carboxylatomethyl)amino]propyl}(carboxylatomethyl)amino)acetate hydrate

Details on test material:

Name: M-3175; 1,3-propylenediamine-N,N,N',N'-tetra acetic acid, ammonium iron (+3) salt (mentioned in 28-day study report)
Appearance: yellow powder
Batch No.: VG-01
Purity: 99% (mentioned in 28-day study report)

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: see below

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

50, 158, 500, 1580, 5000 µg/plate

Vehicle / solvent:

Distilled water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see below

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: triplicate, two independent assays

NUMBER OF CELLS EVALUATED: numbers of revertant colonies were counted, either manually or with a Biotran II automatic colony counter.

DETERMINATION OF CYTOTOXICITY
- Method: absence of growth

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

No increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to M-3175 at levels from 50 to 5000 ug/per plate.

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

It was concluded that M-3175 was devoid of mutagenic activity under the conditions of the test.

Executive summary:

The compound M-3175 was examined for mutagenic activity in four histidine-dependent auxotrophs of Salmonella typhymurium, strains TA 98, TA 100, TA 1535 and TA 1537, using pour-plate assays. Each test, in each strain, was conducted on two separate occasions. The studies, which were conducted in the absence and presence of an activating system derived from rat liver (S-9 mix), employed a range of levels of M-3175 from 50 to 5000 ug per plate, selected following a preliminary toxicity test in strain TA 98, and included solvent (distilled water) controls with and without S-9 mix.

No increases in reversion to prototrophy were obtained-with any of the four bacterial strains at the compound levels tested, either in the presence or absence of S-9 mix. Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2-nitrofluorene, .

2-aminoanthracene, 9-aminoacridine and sodium azide when examined under similar conditions.

It was concluded that M-3175 was devoid of mutagenic activity under the conditions of the test.