4,4'-Isopropylidenediphenol, propoxylated

Genetic toxicity: in vitro

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

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

BP-5P

IUPAC Name:

BP-5P

Constituent 2

Reference substance name:

4,4'-Isopropylidenediphenol, propoxylated

EC Number:

500-097-4

EC Name:

4,4'-Isopropylidenediphenol, propoxylated

Cas Number:

37353-75-6

Molecular formula:

The substance is a UVCB and contains a series of homologues that have the general molecular formula C15H16O2.(C3H6O)n, where 2 ≤ n ≤ 10 (average degree of propoxylation: => 1 ; < 4.5 )

IUPAC Name:

4,4-'isopropylidene, propoxylated (1 - 4.5 moles propoxylated)

Test material form:

liquid: viscous

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

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

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Without S9 mix

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Without S9 mix

Controls 3

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

Remarks:

Without S9 mix

Controls 4

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-AA

Remarks:

With S9 mix

Results and discussion

Test results

Test results 1

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

Test results 2

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.