Registration Dossier

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other: Non-GLP, comparable to guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zirkon-Acetat
- Lot/batch No.: 86/194
- Storage condition of test material: +4 ºC

Method

Target gene:
his
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 (pretreated with Aroclor 1254)
Test concentrations with justification for top dose:
0, 20, 100, 500, 2500 and 5000 μg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (+S9); N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) for TA 100 and TA1535 (-S9), 4-nitro-o-phenylendiamine for TA98 (-S9), 9-aminoacridine chloride monohydrate for TA1537 (-S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation) (tests 1 (TA 100 and TA98) and 2 (TA1535 and TA1537)) and preincubation (test 3)

DURATION
- Preincubation period: 20 minutes at 37 °C (test 3)
- Exposure duration: 48 hours at 37 °C in the dark (test 1, 2 and 3)

NUMBER OF REPLICATIONS: 3 tests were performed; 2 standard plate incorporation assays and 1 preincubation assay. In each test 3 test plates per dose were used.

DETERMINATION OF CYTOTOXICITY
- Method: reduced his(-) background growth
Evaluation criteria:
A substance is considere positive if it fulfills the following criteria:
1) doubling of the spontaneous mutation rate (control)
2) dose-response relationship
3) reproducibility of the results

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
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (reduced his(-) background growth was observed.

TEST-SPECIFIC CONFOUNDING FACTORS:
Water solubility: complete solubility of the test substance in distilled water.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion