(R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride

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 based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Information from published source (NTP), restrictions in design and/or reporting (only 4 strains tested and only one positive control used to test efficacy of the S9-mix), but otherwise adequate for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The substance was tested in a reverse mutation assay (Ames test) using four strains of Salmonella typhimurium (TA 97, TA 98, TA 100, TA 1535) in the presence and absence of metabolic activation.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate

EC Number:

205-154-4

EC Name:

Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate

Cas Number:

134-72-5

IUPAC Name:

2-(methylamino)-1-phenylpropan-1-ol sulfate (2:1) (salt)

Details on test material:

- Name of test material (as cited in study report): ephedrine sulfate

Method

Target gene:

His-locus

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 100, TA 1535, TA 97, TA 98

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9 mix and aroclor 1254-induced hamster liver S9 mix

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3333, 10000 µg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

All strains with metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 97; without metabolic activation

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

TA 98; without metabolic activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 100, TA 1535; without metabolic activation

Details on test system and experimental conditions:

The experiment was performed twice.

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS:
- 3 test plates per dose or per control

Evaluation criteria:

- If the test chemical is mutagenic to any particular strain of bacterium, the number of histidine-independent colonies arising on those plates will be significantly greater than the corresponding control plates for that strain of bacteria.
- The positive control plates are also counted, and the number of mutant colonies appearing on them must be significantly increased over the spontaneous control number for the test to be considered valid. Failure of the positive control chemical to induce mutation is reason to discard the experiment.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 100, TA 1535, TA 97, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

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

It is concluded that there is no evidence of induction of gene mutations by the test substance and its metabolites in the four S. typhimurium strains used in this study.

Executive summary:

The substance was tested for its mutagenic potential based on the ability to induce point mutation in several strains of Salmonella typhimurium (TA 1535, TA 100, TA98, TA 97) in a reverse mutation assay. An increase in the number of his+ revertants was not observed in the preincubation test either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.