Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 mix (Aroclor-1254-induced)
Species / strain:
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
Negative controls:
yes
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see below
Details on test system and 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 resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
other: A bacteriotoxic effect was observed under all test conditions.
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
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.

Applicant's summary and conclusion