Diphenylacetic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Mutagenic Activity Of Styrene Oxide (I,2-Epoxyethylbenzene), A Presumed Styrene Metabolite

Author:

Paul Milvy and Anthony J. Garro

Year:

1976

Bibliographic source:

Mutation Research, 40 (1976) 15-18

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Spot test was performed to determine the mutagenic nature of L- mandelic acid

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

S-Mandelic acid

Cas Number:

17199-29-0

Molecular formula:

C8H8O3

IUPAC Name:

S-Mandelic acid

Details on test material:

- Name of test material: L mandelic acid
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material: L mandelic acid
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other: Strains TA100 and TA98 are derivatives of TA1535 and TA1538 in which an R factor has been introduced. The presence of this plasmid enhances the sensitivity of these strains to the mutagenic effects of some carcinogens

Cytokinesis block (if used):

No data

Metabolic activation:

not specified

Metabolic activation system:

No data

Test concentrations with justification for top dose:

100 µg/plate

Vehicle / solvent:

No data

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: Spot test (in agar)

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: No data

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for an increase in the number of revertants/plate

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98

Metabolic activation:

not specified

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Bacterial growth was inhibited in the immediate vicinity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Any other information on results incl. tables

Table: Revertants/plate

Compound	Revertants/plate
	TA1535	TA 100	TA1537	TA1538	TA98
L mandelic acid	153	492	2	17	8
Spontaneous	135	331	5	14	26

Applicant's summary and conclusion

Conclusions:

L- mandelic acid failed to induce mutation in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538 and TA98 in the spot test performed and hence the chemical is considered to be negative for gene mutation in vitro.

Executive summary:

Spot test was performed to determine the mutagenic nature of L- mandelic acid (IUPAC name: S mandelic acid). The study was performed using Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538 and TA98 at dose levels of 100µg/plate. The plates were observed for an increase in the number of revertants/plate. Spontaneous revertants were also counted in the study. Bacterial growth was inhibited in the immediate vicinity. L- mandelic acid failed to induce mutation in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538 and TA98 in the spot test performed and hence the chemical is considered to be negative for gene mutation in vitro.