Propionaldehyde

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals

Author:

Mortelmans K et al.

Year:

1986

Bibliographic source:

Environ Mutagen 8(1): 1-119

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only four strains used

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Propionaldehyde

EC Number:

204-623-0

EC Name:

Propionaldehyde

Cas Number:

123-38-6

Molecular formula:

C3H6O

IUPAC Name:

propanal

Specific details on test material used for the study:

- Name of test material (as cited in study report): propionaldehyde
- Analytical purity: 97%

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1537 and TA1538

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from rat and hamster liver

Test concentrations with justification for top dose:

100 - 10000 µg/Platte (5 concentrations used)

Vehicle / solvent:

Vehicle used, but no data which one

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

potassium chloride

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without metabolic activation Migrated to IUCLID6: for TA100 and TA1535

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

potassium chloride

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine for TA98

Remarks:

without metabolic activation

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation Migrated to IUCLID6: for TA1537

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

potassium chloride

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene for all strains

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: appearance of his- or pinpoint colonies, reduced numbers of revertant colonies per plate, or thinning or absence of the bacterial lawn

Evaluation criteria:

1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold;
2) nonmutagenic response: when no increase in the number of revertants was elicited by the chemical;
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA100, TA1537 and TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: cytotoxic at high concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Propionaldehyde was not mutagenic in S. typhimurium under the conditions of the assay.