Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[[3-[[3-(dimethylamino)propyl]amino]-1-oxo-2-butenyl]oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate

EC Number:

613-645-3

Cas Number:

646505-36-4

Molecular formula:

see structural formula

IUPAC Name:

Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate

Method

Target gene:

mutant histidine gene

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 100, TA 1537, TA 98, and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 mix was made from the livers of male Sprague Dawley rats, which received a single intraperitoneal injection of 500 mg/kg bw Aroclor 1254, dissolved in corn oil, 5 days prior to sacrifice. The S9 mix comprised 10% S9 fraction.

Test concentrations with justification for top dose:

plate incorporation assay:
0, 50, 158, 500, 1581, 5000 µg/plate with and without S9 mix
preincubation assay:
0, 0.5, 1.6, 5, 16, 50, 158, 500, 1581, 5000 µg/tube with and without S9 mix

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

Na-azide (only TA 1535), nitrofurantoin (only TA 100), 4-nitro-1,2-phenylene diamine (TA 1537 and TA 98), mitomycin C (only TA 102 in plate incorporation assay), cumene hydroperoxide (only TA 102 in preincubation assay), 2-aminoanthracene

Evaluation criteria:

A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgment.
In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.

Statistics:

no statistics perfomed; evaluation based on criteria mentioned above

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 100, TA 1537, TA 98, and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

In the plate incorporation test doses of >= 1581 µg per plate had a strain-specific bacteriotoxic effect. In the preincubation test up to and including 16 µg per tube had no bacteriotoxic effect. At >= 50 µg/tube bacteriotoxic effects occurred.

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

None of the five strains showed a dose-related and/or biologically relevant increase in mutant counts over those of the negative controls.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

The test substance was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and TA 102, performed according to OECD TG 471. The test material was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.