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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Results based on an Ames test with Aluminium magnesium carbonate hydroxide and read-across from Alcamizer 5 and Aluminium-magnesium-zinc-carbonate-hydroxide.

 

EC #

423-570-6

422-150-1

not yet assigned

Name

P93

Alcamizer 5

Aluminium magnesium carbonate hydroxide

Ames test

negative

negative

negative

Chromosome aberration

negative

negative

read across: negative

Mouse lymphoma

negative

no data

read across:

negative

 


Short description of key information:
An AMES test with the registered substance DHT 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.

Read-across:
Aluminium-magnesium-zinc-carbonate-hydroxide (EC 423-570-6):
Ames study performed according to EEC-Directive 92/69 B.14 Ames test EEC-Directive 92/69 B.13 and GLP: Negative
Chromosome aberration study performed according to EEC-Directive 92/69 B.10 and GLP: Negative
In vitro mammalian cell gene mutation test with L5178Y mouse lymphoma cells performed according to OECD 476 and EC Directive 2000/32 and GLP: Negative

Read-across:
Alcamizer 5 (EC 422-150-1):
Ames study performed according to EEC-Directive 92/69 B.14 Ames test and GLP: Negative
Chromosome aberration study performed according to EEC-Directive 92/69 B.10 and GLP: Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the studies performed with the substance and substance analogues, the substance Aluminium magnesium carbonate hydroxide does not have to be classified for genetic toxicity according to Regulation (EC) No 1272/2008.