2-Propenoic acid, reaction products with pentaerythritol

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:

March 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines (with deviations).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Recommended set of five strains not used; duplicate/triplicate plating not used with all strains

GLP compliance:

no

Remarks:

pre-GLP

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, reaction products with pentaerythritol

EC Number:

629-850-6

Cas Number:

1245638-61-2

Molecular formula:

Not available for this UVCB.

IUPAC Name:

2-Propenoic acid, reaction products with pentaerythritol

Details on test material:

- Name of test material (as cited in study report): SN-1738 pentaerythritol triacrylate
- Physical state: Clear viscous liquid

Method

Target gene:

Not applicable

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain 3

Species / strain / cell type:

Saccharomyces cerevisiae

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other: strain D4

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver

Test concentrations with justification for top dose:

0.1, 1, 5 and 10 µL/plate

Vehicle / solvent:

No data

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

solvent

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Anthramine, 2-Acetylaminofluorene, 8-Aminoquinoline, Dimethylnitrosamine

Remarks:

with metabolic activation

Controls 2

Untreated negative controls:

yes

Remarks:

solvent

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Methylnitrosoguanidine, 2-Nitrofluorene, Quinacrine mustard

Remarks:

without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48-72 h at 37 °C


NUMBER OF CELLS EVALUATED: 10^9


NUMBER OF REPLICATIONS: Single plate/dose, no replication

Evaluation criteria:

- Dose-related increases in mutant counts were considered as an indication of mutagenicity
- Mutant increases at only one or two doses may be significant if they occur at the higher doses
- Increases at low or intermediate concentrations followed by reduced mutant counts at higher doses may indicate that the test chemical has a narrow activity range or that the high dose levels were toxic and the induced revertant cells were killed

Statistics:

No data

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 10 µL

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

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:

cytotoxicity

Remarks:

at 10 µL for all strains except TA-100

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

Saccharomyces cerevisiae

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:

INTERPRETATION OF RESULTS AND CONCLUSIONS

The test substance, was examined for mutagenic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces indicator organisms. The test substance was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor-induced rats.

The following results were obtained:

A. Toxicity

The test substance was tested over a series of concentrations such that there was evidence of some chemically-induced physiological effects at the high dose level. The low dose in all cases was below a concentration that demonstrated any toxic effect. The dose range employed for the evaluation of this test substance was 0.1 µL to 10 µL per plate. A considerably high toxicity level was observed at the high dose level for all strains except TA-100 and D4.

B. Non-activation Test Results

The results of the tests conducted on the test substance in the absence of a metabolic system were all negative.

C. Activation Test Results

The results of the tests conducted on the test substance in the presence of the rat liver activation system were all negative.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The substance was negative for mutagenicity (with or without metabolic activation) under the conditions of this Ames test.

Executive summary:

An Ames test was performed to determine the mutagenicity potential of SN-1738 pentaerythritol triacrylate.

Saccharomyces cerevisiae, strain D4 and Salmonella typhimurium strains TA1535, 1537, 1538, 98 and 100 were treated with the substance using the plate incorporation method at four dose levels (0.1, 1, 5 and 10 µL/plate) both with and without metabolic activation (1254 -Aroclor-induced rat liver). A considerably high toxicity level was observed at the high dose level for all strains except TA-100 and D4. Concurrent strain-specific positive and solvent controls, both with and without metabolic activation, were included in each assay.

The results of the tests conducted in the absence and presence of a metabolic activation system were negative.

In conclusion , the substance was not mutagenic under the conditions of this Ames test.