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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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other: Non-GLP, comparable to guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Zirconium di(acetate) oxide
EC Number:
225-924-3
EC Name:
Zirconium di(acetate) oxide
Cas Number:
5153-24-2
IUPAC Name:
5153-24-2
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 considered 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