Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
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:
other: No information on replication. Purity of test substance not reported.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of various chemicals including nickel and cobalt compounds in cultured mouse FM3A cells.
Author:
Morita, H., M. Umeda, and H.I. Ogawa.
Year:
1991
Bibliographic source:
Mutation Research. 261:131-137.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
Version / remarks:
Nakamura et al.
Principles of method if other than guideline:
Year: 1983 (unclear if "Year of test guideline" or "Year of study completion".)
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel dichloride
EC Number:
231-743-0
EC Name:
Nickel dichloride
Cas Number:
7718-54-9
Molecular formula:
Cl2Ni
IUPAC Name:
nickel(2+) dichloride
Details on test material:
- Reported as NiCl-6H20 (7791-20-0)
- Source: Wako Pure Chemical Industries.

Method

Species / strain
Species / strain / cell type:
other: Mouse mammary carcinoma cells (FM3A)
Metabolic activation:
with and without
Metabolic activation system:
2.5% S15
Test concentrations with justification for top dose:
0, 1.0 x 10e-4, 2.0 x 10e-4, 3.0 x 10e-4, and 4.0 x 10e-4 M
Controls
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Details on test system and experimental conditions:
FM3A cells were exposed to hypoxanthine, aminopterin, and thymidine for 1 week prior to use in the mutation assay, 
then cultured in Eagle's minimum essential medium supplemented with 3% fetal bovine serum, 1%  non-essential 
amino acids, hypoxanthine, and thymidine.  Cultured FM3A cells were then exposed to various concentrations of 
NiCl2 for 3-48  hours, washed in Hank's balanced salt solution, and then cultured for an additional 7 days.  
Then, 2 x 10e6 cells were inoculated into 40 ml of  selective agar medium containing 10 ug/ml 6-thioguanine (6-TG) and cultured for 14 days.  
The number of 6TG colonies were counted and  mutation frequency (per 10e6 surviving cells) was determined.    
Statistics:
Statistical analysis was performed using the Welch test. 

Results and discussion

Test results
Species / strain:
mammalian cell line, other: Mouse mammary carcinoma cells (FM3A)
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Additional information on results:
There was a concentration-dependent decrease in percent cell survival following treatment.  
At 0 M treatment, survival was 76%, with 100%  relative plating efficiencies.  
This decreased to 7% survival with relative plating efficiencies of 9% after treatment at 4.0 x 10e-4 M.   
The number of mutants per 10e6 surviving cells increased in a concentration-dependent manner, 
with a significant (P<0.05) increase seen at 4 x 10e-4 M.

Applicant's summary and conclusion

Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER.