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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
Study period:
July 10, 2001
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1988
Deviations:
no
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethylbis[(1-oxoneodecyl)oxy]stannane
EC Number:
273-028-6
EC Name:
Dimethylbis[(1-oxoneodecyl)oxy]stannane
Cas Number:
68928-76-7
Molecular formula:
C22H44O4Sn
IUPAC Name:
[(7,7-dimethyloctanoyl)oxy]dimethylstannyl 7,7-dimethyloctanoate
Test material form:
liquid
Details on test material:
Batch 106946

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
Metabolic activation system:
Aroclor 1254-induced rat liver S9 homogenate was used as the metabolic activation system
Test concentrations with justification for top dose:
75-5000 µg/plate
based on preliminary DRF toxicity was generally observed at 3333 and 5000 µg / plate
Vehicle / solvent:
Acetone CAS 67-64-1
Controls
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
methylmethanesulfonate
other: 2-Aminoanthracene
Details on test system and experimental conditions:
The stidy was conducted in two phases, usin preincubation method. The first phase, the preliminary toxicity study, was used to establish the dose range for the mutagenicity assay. The scond phase, the mutagenicity assay (initial and independent repeat assays), was used to evaluate the mutagenic potential of the test article. Bacterial strainswere treated with either a vehicle control, an appropriate positive control, or with one of ten (preliminary assay) or one of at least five (mutagenicity assay dose levels of Fomrez UL-28 in the presence or abscence of S9. Treated plates were incubated for approximately 48 to 72 hours at 37 °C. All samples were tested singly (preliminary assay) or in triplicate (mutagenicity assay) at each dose level

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study Fomrez UL-28 was considered to be negative in the bacterial reverse mutation assay with independent repeat assay