Registration Dossier
Registration Dossier
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EC number: 232-051-1 | CAS number: 7784-18-1
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:
- supporting study
- Study period:
- 1985
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Significant methodological deficiencies
Data source
Reference
- Reference Type:
- publication
- Title:
- The Results of Microbial Mutation Test for Forty-Three Industrial Chemicals
- Author:
- Shimizu H, Suzuki Y, Takemura N, Goto S & Matsushita H
- Year:
- 1 985
- Bibliographic source:
- Jpn. J. Ind. Health, 1985, Vol. 27, pp. 400-419
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Study results deemed unreliable since it is not clear as to whether or not the compound dissolved in the diluent
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Aluminium fluoride
- EC Number:
- 232-051-1
- EC Name:
- Aluminium fluoride
- Cas Number:
- 7784-18-1
- Molecular formula:
- AlF3
- IUPAC Name:
- aluminum trifluoride
- Details on test material:
- - Name of test material (as cited in study report): Aluminum fluoride
- Physical state: Not reported
- Analytical purity: Reported as 90%
- Lot/batch No.: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Polychlorinated biphenyl-induced rat liver microsomes (S9)
- Test concentrations with justification for top dose:
- 1, 5, 10, 50, 100, 500, 1000, or 5000 µg/plate
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water (not reported whether or not this water was distilled or nanopure or tap)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See Table 1
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
- Remarks:
- However, it is unclear as to whether or not the test substance dissolved in the diluent and therefore the reliability of the negative result is questionable.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- However, it is unclear as to whether or not the test substance dissolved in the diluent and therefore the reliability of this finding is questionable.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- However, it is unclear as to whether or not the test substance dissolved in the diluent and therefore the reliability of the negative result is questionable.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- However, it is unclear as to whether or not the test substance dissolved in the diluent and therefore the reliability of this finding is questionable.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- However, it is unclear as to whether or not the test substance dissolved in the diluent and therefore the reliability of the negative result is questionable.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- However, it is unclear as to whether or not the test substance dissolved in the diluent and therefore the reliability of this finding is questionable.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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):
ambiguous
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