Manganese, [[2,2',2''-[nitrilotris[2,1-ethanediyl(nitrilo-.kappa.N)methylidyne]]tris[phenolato-.kappa.O]](3-)]-, (OC-6-22)-

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted July 21, 1997

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

479-540-8

EC Name:

-

Cas Number:

61007-89-4

Molecular formula:

C27 H27 Mn N4 O3

IUPAC Name:

manganese(3+) 2-[({2-[bis(2-{[(2-oxidophenyl)methylidene]amino}ethyl)amino]ethyl}imino)methyl]benzen-1-olate

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix from phenobarbital and ß-naphthoflavone induced liver of male Wistar rats.

Test concentrations with justification for top dose:

Experiment I: 0; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 0; 33; 100; 333; 1000; 2500; and 5000 µg/plate

Vehicle / solvent:

- Solvent used: dimethylsulfoxide

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Without S9-mix: Sodium azide (TA 1535, TA 100); 4-nitro-o-phenylene-diamine (TA 1537, TA 98); methyl methane sulfonate (WP2 uvrA); With S9-mix: 2-aminoanthracene (TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA)

Details on test system and experimental conditions:

METHOD OF APPLICATION:
Experiment 1: in agar (plate incorporation)
Experiment 2: preincubation

DURATION
- Exposure duration: 48 hrs

NUMBER OF INDEPENDENT EXPERIMENTS: 2
NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: colony counting

Evaluation criteria:

Reaction to a substance is regarded as positive if all of the following criteria are met
- doubling of spontaneous control mutation rate
- dose-response relationship
- reproducibility of results

Statistics:

Not performed.

Results and discussion

Test results

Test results 1

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Evaporation from medium: no
- Precipitation: The test item precipitated in the overlay agar at concentrations of 5000 µg/plate (TA98; without S9-mix), at 333 -5000 µg/plate (TA 100; with and without S9-mix), 333 -5000 µg/plate (WP2 UVrA; without S9-mix) and at 2500 - 5000 µg/plate (WP2 UVrA; with and without S9-mix).

COMPARISON WITH HISTORICAL CONTROL DATA:
The historical range of positive controls was exceeded in strains TA 1535 and TA 100 in both independent experiments without metabolic activation system. This effect indicates the sensitivity of the strains rather than comprising the assay.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation in experiment I. In experiment II, toxic effects were observed at higher concentrations with and without metabolic activation in nearly all S. typhimuriumstrains used.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.