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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Genotoxicity studies of heavy metals: lead, bismuth, indium, silver and antimony
Author:
Asakura K, Satoh H, Chiba M, Okamoto M, Serizawa K, Nakano M and Omae K.
Year:
2009
Bibliographic source:
J Occup Health, 51(6):498-512

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Remarks:
GLP compliance not specified in publication
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Zinc chloride
EC Number:
231-592-0
EC Name:
Zinc chloride
Cas Number:
7646-85-7
Molecular formula:
ZnCl2
IUPAC Name:
Zinc dichloride
Details on test material:
indium (In, 99%, 45µm, 67246G) kept at room temperature in a dark place until use

Method

Target gene:
not applicable
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
5,000; 1,250; 313; 78.1; 19.5; 4.88; 1.22 and 0.305 µg/plate (dose-finding test)
5,000; 2,500; 1,250; 625; and 313 µg/plate (main test)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Remarks:
solvent DMSO
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
With S9mix: 2-AA (TA 100; TA 1535, TA 1537, TA98 and WP2µvrA/pKM101. Without S9 mix: AF-2 (TA 100, TA 98 and WP2µvrA/pKM101), NaN3 (TA 1535), 9-AA (TA 1537)
Positive control substance:
9-aminoacridine
sodium azide
furylfuramide
other: 2-AA (2-aminoanthracene)
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20min at 37°C


NUMBER OF REPLICATIONS: 3

Evaluation criteria:
The test substance was judged to be mutagnic (or positive) when the mean number of revertant colonies dose-dependently increased two-fold or more than that of the corresponding negative control for at least one tester strain with or without S9mix.
Statistics:
the data was not analyzed statistically

Results and discussion

Test resultsopen allclose all
Key result
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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
none

Any other information on results incl. tables

-dose-finding test: the numbers of revertant colonies were less than twice that of the corresponding negative (solvent) control in all tester strains with or without S9 mix.

-main test: the numbers of revertant colonies were less than twice that of the corresponding negative (solvent) control in all tester strains with or without S9 mix.

Applicant's summary and conclusion

Conclusions:
The test material was considered to be non-mutagenic for all the used bacterial strains (Salmonella typhimurium as well as Escherichia coli) with as well as without metabolic activation
Executive summary:

A study was conducted to determine the potential mutagenicity of the test material using bacterial reverse mutation assay (e.g. Ames test). 

No significant increases in the frequency of revertant colonies were recorded at any dose level.

 

The test material was considered to be non-mutagenic under the conditions of this test.