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Registration Dossier
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EC number: 701-289-2 | 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
- Justification for type of information:
- The substance is sparinglly soluble in water. The main component is metallic alumina. Read-across from Al3+ ion to Al metallic is justified.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
- Justification for type of information:
- The substance is sparinglly soluble in water. The main component is metallic alumina. Read-across from Al3+ ion to Al metallic is justified.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Ames test in Salmonella typhimurium strain TA102
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: detects oxidative mutagens and mutagens that produce base-pair (AT->GC) substitution.
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 10, 30, 100, 300, 1000 nM aluminium chloride hexahydrate/plate (corresponding to 1.12, 3.35, 11.18, 33.53, 111.75 nM aluminium/plate)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Remarks:
- 0.125 nM/plate
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: The threshold toxic dose is the dose that decreases the bacterial backgroud lawn estimated by examination with the inverted microscope. - Evaluation criteria:
- A compound is considered a mutagen if there is a dose/effect relation, reproducibility of the effect and the number of revertants is twice the number of spontaneous revertants.
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to highest concentration tested
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information):
negative
Aluminium chloride hexahydrate was neither mutagenic nor cytotoxic in Salmonella typhimurium TA102 at concentrations up to 1000 nM/plate (corresponding to ca. 111.75 nM aluminium/plate).
Aluminium chloride hexahydrate was not mutagenic in Salmonella typhimurium TA102 at concentrations up to 1000 nM/plate (corresponding to ca. 111.75 nM aluminium/plate). The threshold toxic dose was greater than the highest dose tested. Detailed results on the mean number of revertants per plate were not presented for aluminium chloride hexahydrate, but only for chromium compounds as well as the negative and positive controls.
The mean number of revertants in the negative control (± standard deviation) was 258 ± 50.
The mean number of revertants in the positive control (± standard deviation) was 1164 ± 208.
Data source
Reference
- Reference Type:
- publication
- Title:
- Study of mutagenicity of metal derivatives with Salmonella typhimurium TA102
- Author:
- Marzin, D.R. and Phi, H.V.
- Year:
- 1 985
- Bibliographic source:
- Mutation Research 155(1-2):49-51
Materials and methods
- Principles of method if other than guideline:
- Ames test in Salmonella typhimurium strain TA102
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- aluminium chloride hexahydrate
- IUPAC Name:
- aluminium chloride hexahydrate
- Details on test material:
- - Name of test material (as cited in study report): aluminium chloride hexahydrate
- Analytical purity: no data
- Source: Merck, Darmstadt, Germany
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: detects oxidative mutagens and mutagens that produce base-pair (AT->GC) substitution.
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 10, 30, 100, 300, 1000 nM aluminium chloride hexahydrate/plate (corresponding to 1.12, 3.35, 11.18, 33.53, 111.75 nM aluminium/plate)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Remarks:
- 0.125 nM/plate
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: The threshold toxic dose is the dose that decreases the bacterial backgroud lawn estimated by examination with the inverted microscope. - Evaluation criteria:
- A compound is considered a mutagen if there is a dose/effect relation, reproducibility of the effect and the number of revertants is twice the number of spontaneous revertants.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to highest concentration tested
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Aluminium chloride hexahydrate was not mutagenic in Salmonella typhimurium TA102 at concentrations up to 1000 nM/plate (corresponding to ca. 111.75 nM aluminium/plate). The threshold toxic dose was greater than the highest dose tested. Detailed results on the mean number of revertants per plate were not presented for aluminium chloride hexahydrate, but only for chromium compounds as well as the negative and positive controls.
The mean number of revertants in the negative control (± standard deviation) was 258 ± 50.
The mean number of revertants in the positive control (± standard deviation) was 1164 ± 208.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Aluminium chloride hexahydrate was neither mutagenic nor cytotoxic in Salmonella typhimurium TA102 at concentrations up to 1000 nM/plate (corresponding to ca. 111.75 nM aluminium/plate).
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