Trinickel dicitrate

Genetic toxicity: in vitro

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

Reference

Reference 1

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 2

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

Test material information

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