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Toxicological information

Genetic toxicity: in vivo

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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

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.

Applicant's summary and conclusion