Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
STUDY OF ARTIFICIAL FLAVOURING SUBSTANCES FOR MUTAGENICITY IN THE SALMONELLA/MICROSOME, BASC AND MICRONUCLEUS TESTS.
Author:
D. WILD, M.-T. KING, E. GOCKE and K. ECKHARDT
Year:
1983
Bibliographic source:
Fd Chem. Toxic'. Vol. 21, No. 6, pp. 707-719, 1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below principle
Principles of method if other than guideline:
Toxicity of 2 Phenylpropionaldehyde was study using Salmonella/mammalian microsome test (Ames test).
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
Details on test material
- Name of test material (as cited in study report): 2 Phenylpropionaldehyde (synonym-Hydratropic aldehyde)
- Molecular formula (if other than submission substance): C9-H10-O
- Molecular weight (if other than submission substance): 134.177 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:
No data available
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 100, TA 1537,TA1538 and TA98
Details on mammalian cell type (if applicable):
No data available
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-pretreated rats
Test concentrations with justification for top dose:
up to 3.6 mg/plate(Five doses were taken)
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
Remarks:
No other data available
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: plate incorporation method using Vogel Bonnet Medium
DURATION
- Preincubation period: No data available
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS:
No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:

OTHER:
Evaluation criteria:
numbers of revertants/plate were calculated

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 1535, TA 100, TA 1537,TA1538 and TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: Negative (with and without)

After experiment, end point for genetic toxicity for 2 Phenylpropionaldehyde(93-53-8) was determined to be negative with and without activation.
Executive summary:

2 Phenylpropionaldehyde artificial flavouring substance in food products was studied for mutagenic properties by the use of the Salmonella/mammalian microsome test (Ames test).

 

The test was performed by plate incorporation method at 5 different dosesupto 3600 µg/plate and the plates were incubated for 48hrs.

 

2 Phenylpropionaldehyde is non mutagenic when Salmonella/microsome AMES test is performed.