[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed guideline like study with GLP but without confirmation of negative results by furher testing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Green, 1976

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel

EC Number:

255-965-2

EC Name:

[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel

Cas Number:

42844-93-9

Molecular formula:

C29H18N4NiO3

IUPAC Name:

Nickel, [1,3-dihydro-5,6-bis[[[2-(hydroxy-kO)-1-naphthalenyl]methylene]amino-kN]-2H-benzimidazol-2-onato(2-)]-, (SP-4-2)-

Test material form:

solid: nanoform

Method

Species / strain

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

AROCLOR 1254 induced rat liver S-9 mix

Test concentrations with justification for top dose:

1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 AND 5000 µg/plate

Vehicle / solvent:

DIMETHYLSULFOXIDE

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: METHYL METHANE SULFONATE, N-ETHYL-N-NITRO-N-NITROSOGUANIDINE, 2-AMINOANTHRACENE

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation

NUMBER OF REPLICATIONS: TRIPLICATE PLATES, without confirmation of negative results by further testing

Evaluation criteria:

SPECIAL ATTENTION WAS GIVEN TO A REPRODUCIBLE DOSE-EFFECT RELATIONSHIP.
A MUTAGENIC ACTIVITY IS ASSUMED IF AT LEAST A TWO FOLD INCREASE OF THE NUMBER OF INDUCED REVERTANTS IS OBTAINED IN COMPARISON WITH THE SPONTANEOUS REVERTANTS OF THE CORRESPONDING CONTROL.

Results and discussion

Test results

Key result

Species / strain:

E. coli WP2 uvr A

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

Applicant's summary and conclusion

Conclusions:

IN CONCLUSION IT CAN BE STATED THAT DURING THIS IN VITRO ESCHERICHIA COLI REVERSE MUTATION ASSAY NO GENE MUTAGENIC ACTIVITY COULD BE DEMONSTRATED UNDER THE EXPERIMENTAL CONDITIONS REPORTED.

Executive summary:

THE TEST ITEM WAS TESTED FOR DETECTING ITS POTENTIAL GENE MUTAGENIC ACTIYITY ACCORDING TO THE PLATE INCORPORATION METHOD OF GREEN ET AL, USING THE ESCHERICHIA COLI STRAIN WP2UVRA.

THE TEST WAS PERFORMED WITH AND WITHOUT LIVER MICROSOMAL ACTIYATION. THE TEST MATERIAL WAS TESTED AT EIGHT CONCENTRATIONS: 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 AND 5000 MICROGRAMS (MCG) PER PLATE. EACH COMPOUND CONCENTRATION INCLUDING CONTROLS WAS TESTED IN TRIPLICATE.

A VERY SLIGHT PRECIPITATION OF THE TEST MATERIAL WAS OBSERYED AFTER POURING THE CONTENT OF THE TEST TUBE OVER THE SURFACE OF THE SELECTIYE AGAR PLATE AT THE CONCENTRATIONS OF 1580 AND 5000 MCG PER PLATE. THE REVERTANTS WERE EASILY RECOGNIZABLE AND THE PLATES COULD BE EYALUATED.

UP TO THE HIGHEST TESTED DOSE, WITH AND WITHOUT LIVER MICROSOMAL ACTIYATION, NO RELEVANT INCREASE OF THE REVERTANT COLONY NUMBERS WAS OBTAINED IN COMPARISON WITH THE CORRESPONDING CONTROLS.

NO TOXIC EFFECTS OF THE TEST MATERIAL WERE OBSERVED.