Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. No test with a strain detecting oxidizing / cross-linking activity (e.g. Salmonella typhimurium TA102 / Escherichia coli WP2 uvrA) included.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
cited as EEC Directive 84/449, B14.
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyanoacetic acid
EC Number:
206-743-9
EC Name:
Cyanoacetic acid
Cas Number:
372-09-8
Molecular formula:
C3H3NO2
IUPAC Name:
cyanoacetic acid
Details on test material:
- Name of test material (as cited in study report): Cyanessigsäure, techn. krist. (cyanoacetic acid)
- Physical state: solid (white to light yellow-green, crystalline substance)
- Analytical purity: 98.6%
- Lot/batch No.: 08511
- Storage condition of test material: at room temperature
No further data.

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254induced rat liver S-9
Test concentrations with justification for top dose:
4 - 5000 µg/plate; for details, see freetext below
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene, methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine chloride monohydrate
Remarks:
Positive control substance depending on the tester strain and activation condition
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth, decrease in the number of his+ revertants
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 1000 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Mutagenicity

An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.

Toxicity

A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed, depending on the strain and test conditions at doses >= 1000 µg/plate.

Solubility

Complete solubility of the test substance in distilled water at all concentrations tested.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative