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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: basic data given

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Genotoxic activity and potency of 135 compounds in the Ames reversion test and in a bacterial DNA-repair test.
Author:
De Flora, S. et al.
Year:
1984
Bibliographic source:
Mutation Research 133, 161-198
Reference Type:
secondary source
Title:
Nickel Chloride, CAS-No.: 7718-54-9, EINECS-No.: 231-743-0, RISK ASSESSMENT Final version March 2008, Chapters 0, 1, 2, 4, 5, 6 & 7 –human health only
Author:
Danish Environmental Protection Agency
Year:
2008
Bibliographic source:
European Union Risk Assessment Report

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

Constituent 1
Reference substance name:
Nickel dichloride
EC Number:
231-743-0
EC Name:
Nickel dichloride
Cas Number:
7718-54-9
IUPAC Name:
nickel(2+) dichloride
Constituent 2
Reference substance name:
Nickel chloride
EC Number:
253-399-0
EC Name:
Nickel chloride
Cas Number:
37211-05-5
IUPAC Name:
nickel(2+) dichloride
Details on test material:
- Name of test material (as cited in study report): nickel chloride from BDH
- Analytical purity: reagent grade pure

Method

Target gene:
his operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100 and TA 97
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 from Aroclor-treated Sprague-Dawley rats
Test concentrations with justification for top dose:
Test concentrations are not given in the text.
Vehicle / solvent:
bidistilled water or DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Comparative study; known genotoxic chemicals were included.
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation


DURATION
- Preincubation period: 2h


NUMBER OF REPLICATIONS: duplicate and triplicate plates


DETERMINATION OF CYTOTOXICITY
- Method: survival index ( = percent survival of the repair-deficient strain by the percent survival of the wild strain)
Evaluation criteria:
Criteria for positivity of results included rate of increase of induced versus spontaneous revertants, dose dependence and reproducibility in separate experiments.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100 and TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
Potency (revertants/nmole) < 0.0007
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative