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EC number: 839-944-0 | CAS number: 865304-71-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3rd October 2017 - 16th October 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Remarks:
- Not performed according to GLP as done for in-house worker safety purposes and not for Reach.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5-[4-methoxy-2-(propan-2-yl)phenoxy]pyrimidine-2,4-diamine
- EC Number:
- 839-944-0
- Cas Number:
- 865304-71-8
- Molecular formula:
- C14H18N4O2
- IUPAC Name:
- 5-[4-methoxy-2-(propan-2-yl)phenoxy]pyrimidine-2,4-diamine
- Test material form:
- solid: crystalline
- Details on test material:
-
Off-white
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver extract (S-9) from rats pre-treated with Xenobiotics
- Test concentrations with justification for top dose:
- 5000, 3000, 1,000, 300, 100 and 30 μg/plate.
The top dose was limited due to toxicity beginning at 100 μg/plate in the Salmonella test strains and at 300 μg/plate in the E. coli test strain. - Vehicle / solvent:
- L-001739764 was tested as a suspension in dimethyl sulfoxide (DMSO).
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic action
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- other:
- Remarks:
- without metabolic activation
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100μg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100μg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200μg/plate with metabolic action
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100μg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100μg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
Applicant's summary and conclusion
- Conclusions:
- L-001739764 is not mutagenic in bacteria and is negative in the Microbial Mutagenesis Assay.
- Executive summary:
L-001739764, a Production Intermediate, was tested over a concentration range of 30 to 5000 μg/plate in a 5-strain Ames assay. In the first assay (TT #17-8113), the top dose was limited due to toxicity beginning at 100 μg/plate in the Salmonella test strains and at 300 μg/plate in the E. coli test strain. A repeat study (TT #17-8120) was performed at lower doses, 1 to 200 μg/plate, in all 5 strains. Toxicity was observed beginning at 100 μg/plate in the Salmonella test strains. Precipitate was seen on the plates beginning at 1000 μg/plate.
L-001739764 did not produce any 2-fold or greater increases in revertants relative to the solvent control in any of the strains tested, either with or without metabolic activation.
L-001739764 is negative in the Microbial Mutagenesis Assay.
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