Reaction mass of hexadecyl acrylate and octadecyl acrylate

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:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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:

2-Propenoic acid, C16-18-alkyl esters

EC Number:

292-060-1

EC Name:

2-Propenoic acid, C16-18-alkyl esters

Cas Number:

90530-21-5

IUPAC Name:

2-Propenoic acid, C16-18-alkyl esters

Details on test material:

- Name of test material (as cited in study report): Stearylacrylate, Synative MM SA, Stearyl 1618
- Physical state: Liquid to solid, yellowish, turbid
- Analytical purity: 95.1 corr. area% as a sum of two main compounds C16 and C18-fatty alcohol acrylate
- Lot/batch No.: 0007943646

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix prepared from Wistar rats (induced with phenobarbital and β-naphthoflavone)

Test concentrations with justification for top dose:

0, 33, 100, 333, 1000, 2750, 5500 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in ultrapure water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

With S9 mix: 2-aminoanthracene (2-AA); Without S9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 4-nitro-o-phenylenediamine (NOPD), 9-aminoacridine (AAC), 4-nitroquinoline-N-oxide (4-NQO)

Details on test system and experimental conditions:

METHOD OF APPLICATION:

- Standard plate test with and without S9 mix, Preincubation test with and without S9 mix


DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 h


Each experiment includes negative controls in order to check for possible contaminants (sterility control) and to determine the spontaneous mutation rate (vehicle control).

Positive controls

With S9 mix: 2-aminoanthracene, 2.5 μg/plate - strains: TA 1535, TA 100, TA 1537, TA 98
- 60 μg/plate, - strain: Escherichia coli WP2 uvrA

Without S9 mix
• N-methyl-N'-nitro-N-nitrosoguanidine 5 μg/plate, - strains: TA 1535, TA 100
• 4-nitro-o-phenylenediamine 10 μg/plate, - strain: TA 98
• 9-aminoacridine 100 μg/plate, - strain: TA 1537
• 4-nitroquinoline-N-oxide 5 μg/plate, - strain: E. coli WP2 uvrA

Evaluation criteria:

The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain
• The sterility controls revealed no indication of bacterial contamination
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above
• Fresh bacterial culture containing approximately 109 cells per mL were used. For approval the titer of viable bacteria was ≥ 108 colonies per mL.

Statistics:

not required

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:

valid

Positive controls validity:

valid

Additional information on results:

TOXICITY
No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test and in the preincubation up to the highest required concentration.

SOLUBILITY
Test substance precipitation was found from 2750 μg/plate onward with and without S9 mix.

MUTAGENICITY:
A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.

Thus, under the experimental conditions of this study, the test substance Stearylacrylate, Synative MM SA, Stearyl 1618 is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.