Benzyl(3-hydroxyphenacyl)methylammonium chloride

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:

1999

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl(3-hydroxyphenacyl)methylammonium chloride

EC Number:

276-017-4

EC Name:

Benzyl(3-hydroxyphenacyl)methylammonium chloride

Cas Number:

71786-67-9

Molecular formula:

C16H17NO2.ClH

IUPAC Name:

benzyl(3-hydroxyphenacyl)methylammonium chloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Benzyladrianon HCl
- Physical state: solid
- Analytical purity: 99.07 %
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Test concentrations with justification for top dose:

Without metabolic activation : TA 98 4 µg/plate
TA 100 650 µg/plate

With metabolic activation : TA 98 + TA 100 1 µg

Vehicle / solvent:

Without metabolic activation : TA 98 Saline
TA 100 DMSO

With metabolic activation : TA 98 + TA 100 DMSO

Negativ control : dimethylsulphoxide

Positiv control : - Saline
- DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Saline and DMSO

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar

DURATION
- Preincubation period: Until the cultures reached an O.D. of 0.4 at 700 nm
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 2

Evaluation criteria:

A substance is considered positive ( mutagenic ) in the test if it induces at least a 2-fold, dose related increase in the number of revertants with
respect to the number induces by the solvent control in any other of the tester strains, either with or without metabolic actiavtion. However, any
mean plate count of less than 20 is considered to be not significant.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS

- Precipitation: no

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):
positive

Based on the results of this study it is concluded that Benzyladrianon HCl is mutagenic in the Salmonella typhimurium reverse mutation assay.

Executive summary:

Benzyladrianon HCl was tested in the Salmonella typhimurium reverse mutation assay with two histidine-requiring strains of Salmonella typhimurium ( TA 100 and TA 98 ). To obtain more information about the mutagenicity, an additional test was performed with strain TA 98 in the absence of S9-mix and with strain TA 100 in absence and presence of S9-mix.

In the first experiment, Benzyladrianon HCl was tested up to concentrations of 3000 µg/plate in the absence of S9 -mix in strain TA98. Benzyladrianon HCl was tested up to concentrations of 4000 and 5000 µg/plate in the absence and presence of S9 -mix respectively in strain TA 100. Toxicity was observed at these dose levels.

Benzyladrianon HCl did not precipitate on the plate at this dose level.

In tester strain TA98 in the presence of S9 -mix, Benzyladrianon HCl showed negative responses over the entire dose range, i.e. no dose related, two-fold increase in the number of revertants.In the absence of S9 -mix, Benzyladrianol HCl induced up to 1.9 -and 2.0 -fold, not dose related, increases in the number of revertant colonies compared to the solvents control in the first and second experiment respectively.

In tester strain TA100 in the absence of S9 -mix, Benzyladrianon HCl induced up to 2.1 -and 4.5 -fold, dose related, increases in the number of revertant colonies compared to the solvents control in the first and second experiment respectively.

In the presence of S9 -mix, Benzyladrianon HCl induced up to 3.2 -and 3.0 -fold, dose related, increases in the number of revertant colonies compared to the solvents control in the first and second experiment respectively.

Based on the results of this study it is concluded that Benzyladrianon HCl is mutagenic in the Salmonella typhimurium reverse mutation assay.