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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
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
- Study period:
- 25 February 2008 to 24 March 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Deviation: no analytical certificate of test item
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): CAE
- Substance type: UVCB
- Physical state: liquid
- Analytical purity, Impurities: not applicable (UVCB)
- Lot/batch No.: 1456
- Expiration date of the lot/batch: 31/12/2008
- Storage condition of test material: away from light, under nitrogen, at room temperature
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- - Type and identity of media: agar
- Properly maintained: purchased
- Periodically checked for Mycoplasma contamination: not applicable (purchased)
- Periodically checked for karyotype stability: not applicable (purchased)
- Periodically "cleansed" against high spontaneous background: not applicable (purchased)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: agar
- Properly maintained: purchased
- Periodically checked for Mycoplasma contamination: not applicable (purchased)
- Periodically checked for karyotype stability: not applicable (purchased)
- Periodically "cleansed" against high spontaneous background: not applicable (purchased)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5, 1.5, 0.5, 0.15, 0.05 µL/plate for each strain ate in each experiment.
- Vehicle / solvent:
- None (liquid tgest item).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: 9-Aminoacridine ; 2-Nitrofluorene ; Mitomycin C; 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
First experiments by direct plate incorporation.
Second experiments by preincubation.
DURATION
- Preincubation: 20 min
- Exposure duration: 72 h - Evaluation criteria:
- A reproducible increase in the number of revertants compared with the negative controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Biological significance: from a 2.5-fold increase.
- Statistics:
- Not applicable.
Results and discussion
Test results
- Species / strain:
- other: all tested strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not applicable
- 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 (migrated information):
negative
The test item did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
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