Sodium zirconium lactate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Shortcoming with the method with only three strains and without use of S-9 activation
However, performed at up to high dose levels of 10 000 µg/plate.

Data source

Reference

Reference Type:

publication

Title:

Zirconium Toxicity Assessment Using Bacteria, Algae And Fish Assays

Author:

Couture, P; et al.

Year:

1989

Bibliographic source:

Water, Air, and Soil Pollution 47: 87-100

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium tetrachloride

EC Number:

233-058-2

EC Name:

Zirconium tetrachloride

Cas Number:

10026-11-6

Molecular formula:

Cl4Zr

IUPAC Name:

zirconium tetrachloride

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 102

Metabolic activation:

without

Test concentrations with justification for top dose:

0, 0.01, 0.1, 1.0, or 10.0 mg/L Zr.

Controls

Untreated negative controls:

yes

Evaluation criteria:

Each microplate was scored for positive wells after 72-hr incubation at 37 °C.
Positive responses were shown by a color change from purple to yellow of the pH indicator Bromcresol Purple as a result of cellular growth by His+ revertants.

Statistics:

Chi-square analysis

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 97

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 102

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: some cytotoxicity possible at highest concnetrations tested

Untreated negative controls validity:

valid

Any other information on results incl. tables

Mutagenicity in Salmonella sp. strains (TA97, TAI00, and 102) following exposure to ZrCl4 in a Microtitre Fluctuation Test

Zr (mg L -1)	Number of positive wells			p^a
	TA97	TA100	TA102
0.0	30	31	30	N.S.
0.01	29	20	24	N.S.
0.1	23	21	24	N.S.
1.0	32	34	29	N.S.
10.0	32	35	11^b	N.S.

a Not significant (N.S.) at 95% probability level for all strains. Significance was determined by Chi-square analysis

b Lower number of revertants may indicate toxicity towards strain TA102 at 10 mg L ~ Zr.

Applicant's summary and conclusion

Conclusions:

Zirconium tetrachloride was not mutagenic in a bacterial reverse mutation study without metabolic activation.

Executive summary:

Zirconium tetrachloride was tested in a bacterial reverse mutation study without metabolic activation at doeses of 0, 0.01, 0.1, 1.0, or 10.0 mg/L  Zr. No mutagenic activity was observed in this study.