Propionic anhydride

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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