(2R)-2-(2-chlorophenyl)-2-hydroxyethanoic acid

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(2R)-2-(2-chlorophenyl)-2-hydroxyethanoic acid

EC Number:

444-040-0

EC Name:

(2R)-2-(2-chlorophenyl)-2-hydroxyethanoic acid

Cas Number:

52950-18-2

Molecular formula:

Hill formula: C8H7ClO3 CAS formula: C8H7CLO3

IUPAC Name:

(2R)-2-(2-chlorophenyl)-2-hydroxyacetic acid

Details on test material:

- Name of test material (as cited in study report): (R)-2-Chlormandelsäure
- Physical state: Solid, crystalline 1 white to slight yellowish;
- Analytical purity: 99.7 area-%
- Lot/batch No.: TI 38-02-01
- Stability: The stability under storage conditions over the exposure period was guaranteed by the sponsor.
- Storage condition of test material: room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.
- Other: pH-value of a 10% aqueous suspension: about 1.0

Method

Target gene:

histidine operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 mix (Aroclor-1254-induced)

Test concentrations with justification for top dose:

20 - 5000 µg/plate (SPT); 4 - 2500 µg/plate (PIT)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see below

Details on test system and experimental conditions:

METHOD OF APPLICATION:Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver
S-9 mix).

Results and discussion

Test results

Test results 1

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:

other: A bacteriotoxic effect was observed under all test conditions.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

SOLUBILITY: No precipitation of the test substance was found.

TOXICITY: A bacteriotoxic effect was observed under all test conditions

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

CONCLUSION:
According to the results of the present study, the test substance (R)-2-Chlormandelsäure is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.