Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

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

 

EC #

423-570-6

422-150-1

234-319-3

Name

P93

Alcamizer 5

Magnesium-Aluminium-

Hydroxide-Carbonate

Ames test

negative

negative

read across: negative

Chromosome aberration

negative

negative

read across: negative

Mouse lymphoma

negative

no data

read across:

negative

 


Short description of key information:
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 substance analogues, the substance does not have to be classified for genetic toxicity according to Regulation (EC) No 1272/2008.