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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1st February 2011 to 8th February 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Maraon, D. M. and Ames, B. N., (1983) Revised methods for the Salmonella Mutagenicity Test, Mutagen Research 11:173-215 AND Ames, B. N., J. McCann and E. Yamasaki (1975) Methods for detecting carcinogens and mutagens with the Salmonella/Mammalian Microsome Mutagenicity Test, Mutagen Research 31:347-364
GLP compliance:
not specified
Remarks:
Not specified in the report
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
{1-(ETHYLSULFONYL)-3-[4-(4,4,5,5-TETRAMETHYL-1,3,2-DIOXABOROLAN-2-YL)-1H-PYRAZOL-1-YL]AZETIDIN-3-YL}ACETONITRILE
Cas Number:
191987-50-5
Molecular formula:
C16H25BN4O4S
IUPAC Name:
{1-(ETHYLSULFONYL)-3-[4-(4,4,5,5-TETRAMETHYL-1,3,2-DIOXABOROLAN-2-YL)-1H-PYRAZOL-1-YL]AZETIDIN-3-YL}ACETONITRILE
Test material form:
solid: particulate/powder

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-induced rat liver S9
Test concentrations with justification for top dose:
The dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate.
Vehicle / solvent:
Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
other: 2-aminoanthracene
Remarks:
E.coli WPuvrA
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
other: 2-aminoanthracene
Remarks:
TA1537
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
other: 2-aminoanthracene
Remarks:
TA1535
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
other: 2-aminoanthracene
Remarks:
TA100
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
2-nitrofluorene
other: 2-aminoanthracene
Remarks:
TA98
Details on test system and experimental conditions:
Test article dilutions were prepared immediately before use and delivered to the test system at Room Temperature under yellow light. 0.5ml of S9, 100μl of tester strain and 50μl of vehicle or test article dilution were added to 2ml of molten top agar at 45±2oC. After vortexing, the mixture was overlaid onto the surface of 25ml of minimal bottom agar. For the positive control, a 50μl aliquot of the appropriate positive control was used. After the overlay had solidified, the plates were inverted and incubated for 48-72 hours at 37±2oC. Plates that were not counted immediately were stored at 2-8oC until colony counting could be conducted. The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope. Precipitate was evaluated by visual examination without magnification. Revertant colonies for a given tester strain and activation condition were counted either entirely by automated colony counter or entirely by hand unless the plate exhibited toxicity. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually.
.
Evaluation criteria:
For a test article to be to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 3 times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvr A were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value

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
Vehicle controls validity:
valid
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
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535 pSK1002
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
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
Vehicle controls validity:
valid
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
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Alll crtieria for a valid study were met. The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, test article 3030577 did not cause mutagenic response in any of the tester strains in either the absence or presence of Aroclor-induced rat liver S9.