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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Salmonella mutagenicity tests: II Results from the testing of 270 chemicals.
Author:
Mortelmans, K. et al.
Year:
1986
Bibliographic source:
Envir. Mutagen. 7, 1-119
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US National Toxicology Program
Principles of method if other than guideline:
Preincubation modification of the Ames test (Ames B.N. et al. Mutat. Res. 31, 347 -364, 1975).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acetonitrile
- Analytical purity: >99% purity

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA 97, 98, 100, 1535, 1537
Metabolic activation:
with and without
Metabolic activation system:
ArocIor 1254-induced male Sprague-Dawley rat or Syrian hamster liver
Test concentrations with justification for top dose:
0, 100, 333, 1000, 3333, 10000 ug/plate
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
other: sodium azide, 9-aminoacridine, 4-nitro-o-phenylenediamine, 2-aminoanthracine
Details on test system and experimental conditions:
Ames test: Acetonitrile was evaluated by two testing laboratories as a coded sample.

METHOD OF APPLICATION: Acetonitrile was incubated with the Salmonella typhimurium tester strains (TA97, TA98, TA100, TA1535, and TA1537) either in buffer or S9 mix (metabolic activation enzymes and cofactors from ArocIor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37° C. Top agar supplemented with I-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates.

DURATION
- Exposure duration: 2 days at 37° C.

NUMBER OF REPLICATIONS: All tests were repeated using either the same or different S9 concentrations. Each trial consisted of triplicate plates of concurrent positive and negative controls and at least five doses of acetonitrile.

NUMBER OF CELLS EVALUATED: Histidine-independent mutant colonies arising on these plates were counted following incubation


Evaluation criteria:
A positive response was defined as a reproducible, dose-related increase in revertant colonies in any one strain/activation combination. A negative response was obtained when no increase in revertant colonies was observed following chemical treatment.

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Positive controls validity:
valid
Additional information on results:
In the absence of toxicity, 10,000 ug/plate was selected as the high dose.
Remarks on result:
other: other: Salmonella typhimurium strains TA 97, 98, 100, 1535, 1537
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Data from 2 laboratories gave negative results in all strains.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Acetonitrile was not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, TA1535, or TA1537, with or without S9 metabolic activation.
Executive summary:

In studies conducted by the US National Toxicology Program, Acetonitrile concentrations up to 10,000 ug/plate were not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, TA1535, or TA1537, with or without S9 metabolic activation.