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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
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
Controlsopen allclose all
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
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
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
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:
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.