propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

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

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1992

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:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

EC Number:

701-363-4

Molecular formula:

Not specified UVCB - Reaction product of ethoxylated (0-7 EO) propylidenetrimethanol with acrylic acid and dibutylamine (propylidenetrimethanol with acrylic acid : dibutylamine = 5:1)

IUPAC Name:

propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

Details on test material:

- Name of test material (as cited in study report): Laromer LR8869
- Physical state: nearly colorless liquid
- Analytical purity: >99%
- Lot/batch No.: 22386/142
- Stability under test conditions: verified analytically
- Storage condition of test material: +4 - +6°C

Method

Target gene:

his (salmonella)
trp (e.coli)

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

other: periodically checked for deep rough character, UV sensitivity, and ampicillin resistance

Metabolic activation:

with and without

Metabolic activation system:

arcolor induced S9 mix

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500, 5000µg/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with s9

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N-nitro-N-nitroso-guanidine (TA100 + TA1535); 4-nitro-o-phenylendiamin (TA98); 9-aminoacridine (TA1537); N-ethyl-N-nitro-N-nitroso-guanidin (e.coli WP2)

Remarks:

without S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation;

DURATION
- Preincubation period: none (standard test); 20min (pre-incubation experiment)
- Exposure duration: 48h

SELECTION AGENT (mutation assays): histidine (salmonella), tryptophane (e.coli)

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: titer determination of parallel cultures grown in agar containing maximal amino acid solution (control and two highest concentrations)

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterjal tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility: completely soluble in DMSO


ADDITIONAL INFORMATION ON CYTOTOXICITY:
occasionally a slight decrease in the number of revertant colonies was observed at doses >= 2500µg/plate

Remarks on result:

other: other: standard test and pre-incubation test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

According to the results of the present study, the test substance is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here.

Executive summary:

The test substance was tested for mutagenicity in the Ames test and in the E. coli - reverse mutation assay both in the standard plate test and in the preincubation test with and without the addition of a metabolizing system obtained from rat liver (S-9 mix) using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli 1412 uvrA.

An increase in the number of his + or trp+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.