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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Salonella Mutagenicity Tests: V. Results from the Testing of 311 Chemicals.
Author:
Zeiger E., Anderson B., Haworth S., Lawlor T. and Mortelmans K
Year:
1992
Bibliographic source:
Environmnental and Molecular Mutagenesis Volume 19, Supplement 21: 2-141 (1992)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(limited documentation of results)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Propionic acid
EC Number:
201-176-3
EC Name:
Propionic acid
Cas Number:
79-09-4
Molecular formula:
C3H6O2
IUPAC Name:
propanoic acid
Details on test material:
- Name of test material (as cited in study report): propionic acid
- Source: Aldrich
- Analytical purity: > 99%

Method

Target gene:
His Operon
Species / strain
Species / strain / cell type:
other: S. typhimurium TA97, TA98, TA100, TA102, TA104, TA1535, TA 1537 and TA1538
Details on mammalian cell type (if applicable):
- Type and identity of media: Vogel-Bonner medium
- Regular analysis: yes
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from Aroclor induced liver of Sprague Dawley rats
Test concentrations with justification for top dose:
0, 0, 100, 333, 1000, 3333, and 10,000 μg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 h
- Selection time (if incubation with a selection agent): 48 hours

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: no data

DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was determined by a thinning of the background lawn, and/or a reduction in the number of colonies per plate.

COUNTING
- Plates were machine counted unless precipitation occurred. These were then hand counted
Evaluation criteria:
A chemical was designated non mutagenic only after it had been tested in TA 98, TA 100 TA 1535 and TA97 and /or TA 1537 without metabolic and with 10% and 30% rat and hamster S-9. In case of weak or unclear results, 5% S9 was also tested

Results and discussion

Test results
Species / strain:
other: S. Typhimurium: TA97, TA98, TA100, TA102, TA104, TA1535, TA 1537 and TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
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):
negative with metabolic activation
negative without metabolic activation

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