Dialuminum tetramagnesium carbonate dodecahydroxide

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:

21 September, 1982 - 20 October, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was not performed according a specific guideline (e.g. no batch number or purity of the test substance is given and no independent repeated was performed) and it is not clear whether the study is performed according GLP principles. However, the conclusion is considered reliable and supported by a weight of evidence from analogue substance (P-93 and Alcamizer 5).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Principles of method if other than guideline:

No specific guideline mentioned in the document.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium magnesium carbonate hydroxide

EC Number:

943-434-4

Cas Number:

11097-59-9

Molecular formula:

[Al2Mg4(OH)12] CO3

IUPAC Name:

Aluminium magnesium carbonate hydroxide

Details on test material:

Name (IUPAC): Hydrotalcite-like compound
Name (Usage, trade, etc.): DHT
Chemical formula: Mg3. 5~4. 5Al2(OH)1 1~1 3*CO3 2.5~3.5H2O

Method

Target gene:

WP2uvrA: Tryptophan
TA100, TA98, TA1537, TA1535 and TA1538:Histidine

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone

Test concentrations with justification for top dose:

10, 50, 100, 500, 1000 en 5000 µg/plate

Vehicle / solvent:

- Solvent used: Distilled water

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: ENNG, 2 µg/plate for TA100 and WP2uvrA and 5 µg/plate for TA1535

Remarks:

without S9

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-NF, 1 µg/plate for TA98 and 2 µg/plate for TA1538

Remarks:

without S9

Controls 3

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine, 80 µg/plate for TA1537

Remarks:

without S9

Controls 4

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: benzo(a)pyrene, 5 µg/plate for TA100, TA98, TA1537 and TA1538

Remarks:

with S9

Controls 5

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, 2 µg/plate for TA1535 and 40 µg/plate for WP2uvrA

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min.
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: duplicates in one experiment

Evaluation criteria:

No data.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In an AMES test, performed similar to OECD 473 guideline, DHT was found not to be mutagenic with or without metabolic activation.
Based on the results of this study it is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.

Executive summary:

An AMES test was performed similar to OECD 473 guideline using strains TA98, TA100, TA1535, TA1537, TA1538 and WP2uvrA. All bacterial strains showed negative responses up to 5000 µg/plate, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was seen in one pre-incubation experiment. No cytotoxicity of the test substance was observed.

Based on the results of this study it is concluded that DHT is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.