Cuprate(4-), [.mu.-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-.kappa.O)-4,1-phenylene]-2,1-diazenediyl-.kappa.N1]]bis[4-(hydroxy-.kappa.O)-2,7-naphthalenedisulfonato]](8-)]]di-, ammonium sodium

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: gene mutation

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: non-GLP conform, but similar to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The mutagenicity test was performed on mice. L5178Y-cells were inoculated intraperitoneally (10^6 cells/animal). Three days after inoculation of the target cells the substance was given orally to four animals in the stated dose (530 mg/kg). A further group of four animals served as control. Three days after the administration of the substance, the cells were removed from the peritoneal cavity under aseptic precautions. After centrifugation and washing of the cell cultures were set up in culture tubes (4x10^5 cells/5 mL) in semi-old agar containing antimetabolites (i.e. methotrexate, thymidine, cytosine ararabinoside. Parallel with these cultures a cell-viability control was carried out (100 cells/5 mL were seeded in the same agar without antimetabolites). The incubation time of the mutagenicity test cultures was 14 days, that for cell-viability control 10 days.

GLP compliance:

no

Type of assay:

other: Mouse Lymphoma Test (Host-Mediated Assay)

Test material

Test material information

Constituent 1

Reference substance name:

FAT 11181/E

IUPAC Name:

FAT 11181/E

Test material form:

not specified

Test animals

Species:

mouse

Strain:

DBA

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

- Vehicle/solvent used: polyethylene

Duration of treatment / exposure:

Three days after inoculation of the target cells the substance was given orally to four animals in the stated dose (530 mg/kg). Three days after the administration of the substance, the cells were removed from the peritoneal cavity under aseptic precautions.

Frequency of treatment:

once

Doses / concentrations

Remarks:

Doses / Concentrations:
530 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

test group: 4 animals
control group: 4 animals

Control animals:

yes

Positive control(s):

none

Examinations

Tissues and cell types examined:

The inoculated L5178Y-cells were removed from the peritoneal cavity.

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: The dose selection based on the toxicity study.

TREATMENT AND SAMPLING TIMES: Three days after the administration of the substance, the cells were removed from the peritoneal cavity under aseptic precautions.

DETAILS OF PREPARATION: After centrifugation and washing of the cells cultures were set up in culture tubes (4x10^5 cells/5 mL) in semi-solid agar containing antimetabolites.

METHOD OF ANALYSIS: The values obtained from the viability control served to normalize the results received from the mutagenicity test. The calculated mutant frequency corresponds to the number of colonies per 100,000 viable cells. The mutation factor is calculated by dividing the mutant frequency of the treated cells by the mutant frequency of the control cells.

Evaluation criteria:

The test substance is considered to be non-mutagenic if the mutation factor is not greater than 2.5.

Results and discussion

Test results

Sex:

not specified

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Additional information on results:

Concerning the toxicity test, the highest dose (530 mg/kg) showed no decrease of the number of cells. Therefore, this dose was regarded to be suitable for the mutagenicity study.