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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Original study report in Japanese. Only an english summary was available.
Justification for type of information:
Study was conducted on the test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(1-butyl-3-methyl cyclopentadienyl)Zirconium dichloride
EC Number:
686-816-3
Cas Number:
151840-68-5
Molecular formula:
C20 H30 CL2 Zr1
IUPAC Name:
Bis(1-butyl-3-methyl cyclopentadienyl)Zirconium dichloride
Test material form:
solid

Method

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
Metabolic activation:
with and without
Test concentrations with justification for top dose:
156, 313, 625, 1250, 2500 and 5000 ug/plate
Vehicle / solvent:
Not specified.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain WP2uvrA were exposed to E Catalyst in an Ames preincubation assay. In the preincubation assay, 0.1 ml of each test material dilution was added to the respective bacterial strain in the presence or absence of metabolic activation and was incubated for a twenty minute period prior to the inclusion of soft agar. The entire mixture was subsequently poured into an agar plate and incubated for an additional 48-hour period.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
See data tables in attachment.

Applicant's summary and conclusion

Conclusions:
The E Catalyst did not increase the number of reverse mutation colonies more than twice that of the negative (solvent) control for any of the bacterial strains studied, either in the presence or absence of metabolic activation. Based on these results, this material is considered negative under the test conditions employed.
Executive summary:

The E Catalyst was negative in four strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and in E.coli WP2uvrA in the presence and absence of metabolic activation.