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Toxicological information

Genetic toxicity: in vitro

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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

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.

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).

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:
1985
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

Constituent 1
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

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).