Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-148-6 | CAS number: 103-82-2
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 publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- genetic toxicity study for the given test chemical.
- Author:
- Heck et al.
- Year:
- 1 989
- Bibliographic source:
- The Toxicologist
- Reference Type:
- other: secondary source
- Title:
- Flavouring Group Evaluation 53
- Author:
- EFSA
- Year:
- 2 008
- Bibliographic source:
- The EFSA Journal
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To evaluate mutagenic effects of the given test chemical by the method of Ames reverse mutation assay.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenylacetic acid
- EC Number:
- 203-148-6
- EC Name:
- Phenylacetic acid
- Cas Number:
- 103-82-2
- Molecular formula:
- C8H8O2
- IUPAC Name:
- phenylacetic acid
- Details on test material:
- - Name of test material (as cited in study report): phenylacetic acid
- Substance type: Organic
- Physical state: Solid
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- other: Salmonella strains TA1535, TA1537, TA1538, TA98, and TA100.
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 activation system
- Test concentrations with justification for top dose:
- 1000 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
- Details on test system and experimental conditions:
- No data
- Rationale for test conditions:
- No data
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- other: Salmonella strains TA1535, TA1537, TA1538, TA98, and TA100
- 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
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
- Remarks on result:
- other: No mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- The given test chemical shows negative result in in-vitro bacterial reverse mutation assay test on Salmonella typhimurium strains TA 1538; TA 1535; TA 1537; TA 100; TA 98 with and without S9 metabolic activation. This indicates that the substance is not mutagenic.
- Executive summary:
In-vitro bacterial reverse mutation test was conducted by using the given test chemical to evaluate mutagenic effects on Salmonella typhimurium strains TA 1538; TA 1535; TA 1537; TA 100; TA 98 with and without Aroclor 1254-induced rat liver S9 activation system at the concentration of 1000 μg/plate.
The given test chemical shows negative result in Salmonella typhimurium strains TA 1538; TA 1535; TA 1537; TA 100; TA 98 with and without S9 metabolic activation. This indicates that the substance is not mutagenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
