Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD 471 guideline, however missing the E.coli WP2 strains

Data source

Reference
Reference Type:
publication
Title:
An evaluation of food flavoring ingredients in a genetic toxicity screening battery.
Author:
Heck JD, Vollmuth TA, Cifone MA, Jagannath DR, Myhr B & Curren RD
Year:
1989
Bibliographic source:
The Toxicologist.9(1):257

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
.No E.coli WP2 strain
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Phenylacetic acid
EC Number:
203-148-6
EC Name:
Phenylacetic acid
Cas Number:
103-82-2
IUPAC Name:
phenylacetic acid
Details on test material:
No data

Method

Target gene:
Histidine synthesis in the Salmonella typhimurium strains.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
No Data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254- induced adult male Sprague Dawley rat liver and necessary cofactors as described in Ames et al(1973).
Test concentrations with justification for top dose:
1000 µg or nl/plate

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 / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
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

The test material has been found to be non-mutagenic under the test conditions reported.