[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel

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:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: outdated guideline applied,

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Escherichis coli not included

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel

EC Number:

265-022-7

EC Name:

[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel

Cas Number:

64696-98-6

Molecular formula:

C18H10N4NiO2

IUPAC Name:

[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel

Method

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:

rat liver S9 mix

Test concentrations with justification for top dose:

0 - 4 - 20 - 100 - 500 - 2500 - 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Preincubation period: no
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: other: back groud lawn evaluation, number of spontaneous revertant colonies

Evaluation criteria:

The assay is considered valid if the following criteria are met:
- the solvent control data are within the laboratory's normal control range for the spontaneous mutant frequency.
- the positive controls induced increases in the mutation frequency which were both statistically significant and within the laboratory's normal range.

A test compound is classified as mutagenic if it has either of the following effects:
a) it produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
b) it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.

If the test substance does not achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system.
The test results must be reproducible.

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 nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

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

The test item is not mutagenic in bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.

Executive summary:

The test item was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium.

Two independent mutagenicity studies were conducted, each in the absence and in the presence of a metabolizing system derived from a rat liver homogenate.

For all studies, the compound was suspended in DMSO, and each bacterial strain was exposed to 6 dose levels. Doses for all studies ranged from 4 to 5000 µg/plate.

Control plates without mutagen showed that the number of spontaneous revertant colonies was within the laboratory's historical control range. All the positive control compounds showed the expected increase in the number of revertant colonies.

Toxicity:

In the mutagenicity experiments toxicity was not observed either with or without metabolic activation.

A toxicity test using histidine-enriched agar plates and a dilution of the tester strain TA 1 00 (designated TA 1 00 D) was performed in parallel with the second experiment.

The test compound proved to be not toxic to the bacterial strain.

Mutagenicity:

In the absence and in the presence of the metabolic activation system the test item did not result in relevant increases in the number of revertants in any of the bacterial strains.

The test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.