Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)

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

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

Test material information

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).