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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-658-0 | CAS number: 67-52-7
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well performed GLP and OECD guideline study. But according to a previous guideline a different combination of tester strains was used (i.e. without E. coli WP2 uvrA or TA 102)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted: 26 May 83,
- Deviations:
- yes
- Remarks:
- yes: related to the current guideline version / no: related to the guideline version referenced
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Barbituric acid
- EC Number:
- 200-658-0
- EC Name:
- Barbituric acid
- Cas Number:
- 67-52-7
- Molecular formula:
- C4H4N2O3
- IUPAC Name:
- pyrimidine-2,4,6(1H,3H,5H)-trione
- Details on test material:
- - Name of test material (as cited in study report): Barbituric acid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254(R) induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000, 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionized water for test item, DMSO for positive controls
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- No "untreated" negative control was set up
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- No "untreated" negative control was set up
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation)
DURATION
- Exposure duration: incubation for 48 hours
NUMBER OF REPLICATIONS: 4 plates per strain and dose level, including controls, two independent experiments - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice the amount of negative controls, whereas for TA 1537, at least a threefold increase should be reached. Otherwise, the result is evaluated as negative.
- Statistics:
- Arithmetic means of the counted colonies were calculated.
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- weak effect > 200 µg/plate
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test item did not exert mutagenic activity in the Salmonella typhimurium reverse mutation assay (plate incorporation test) with and without metabolic activation. - Executive summary:
Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98 and100 with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 8, 40, 200, 1000 and 5000 µg/plate according to OECD guideline 471. Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies and no dose dependent effect was observed.
Therefore the test item is not considered mutagenic under the conditions in this bacterial reverse mutation assay.
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.
