1-Butanaminium, 4-hydroxy-N,N,N-trimethyl-4-oxo-, inner salt

Genetic toxicity: in vitro

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:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed under GLP and in accordance with OECD-/EU-testing guidelines

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Details on test material:

- CAS No.: 407-64-7
- Test substance No.: 94/243
- Appearance, consistency: Yellowish liquid
- Storage: Refrigerator

Method

Target gene:

not applicable

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9 mix (activation - Aroclor)

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50 - 12500 µg/plate
Concentration range in the main test (without metabolic activation): 50 - 12500 µg/plate

Vehicle / solvent:

Solvent: purified water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

further positive control substances were used: 9-Aminoacridine (-S9), 2-Nitro-o-phenylendiamine (-S9), 2-Aminoanthracene (+S9)

Migrated to IUCLID6: (-S9)

Details on test system and experimental conditions:

The study was performed by the direct plate incorporation (1st exp.) and preincubation (2nd exp.) method, w ith and without metabolic activation.

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

Statistics:

According to the OECD guideline 471, a statistical analysis of the data is not mandatory.

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No precipitation observed.

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

According to the results of the present study, the aqueous solution of the test item is not mutagenic in the Ames test under the experimental conditions chosen.

Executive summary:

The assay was performed 1995 in compliance with GLP. The test was performed with and without liver microsomal activation and used strains TA 1535, TA 1537, TA 98 and TA 100. The test item was tested at the following concentrations: 50; 250; 1250; 6250 and 12500 µg/plate (1st and 2nd exp..The plates incubated with the test item showed normal back­ground growth up to 12500 µg/plate with and without S9 mix in all strains used. No toxic effects, evident as a reduction in the number of revertants occurred in the test groups with and without metabolic activation. Precipitation was not observed.