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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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: draft report with preliminary results
Title:
Unnamed
Year:
2009
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9: Rat liver, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
-S9 mix: 0, 156, 313, 625, 1250, 2500, 5000μg/plate (TA100, TA1535, TA98, TA1537 and WP2 uvrA)
+S9 mix: 0, 156, 313, 625, 1250, 2500, 5000μg/plate (TA100, TA1535, TA98, TA1537 and WP2 uvrA)
Vehicle / solvent:
Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Without S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Without S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
Remarks:
Without S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-AA
Remarks:
With S9 mix

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:


No mutagenic activity was found in the strain of S. typhimurium and E. coli and toxicity was not observed in any strain, with and without metabolic activation. Bisphenol A propoxylate is not mutagenic.
Executive summary:

To investigate the genetic toxicity of Bisphenol A propoxylated , gene mutation tests in bacteria were conducted with S. typhimurium TA 100, TA 1535, TA 98, TA 1537 and E. coli WP2uvrA strains.

No mutagenic activity was found in all strains of S. typhimurium and E. coli, with and without metabolic activation. Toxicity was not observed in any strain, with and without metabolic activation, up to the limit concentration.

Bisphenol A propoxylate is not mutagenic under the conditions of the test.