Dialuminum tetramagnesium carbonate dodecahydroxide

Endpoint summary

Description of key information

Read-across from analogue substances was applied.
Key value for risk assessment in analogy to RIVM decision for Alcamizer P93, dated 23 October 2007, BMS071023.03: 
28-d NOAEL 1000 mg/kg bw/d (read-across from substance with EC no. 423-570-6)
For the analogue P93 RIVM concluded: 
Based on the fact that the NOAEL of 1000 mg/kg bw/d from the 28-d study of the analogue is much higher than the NOAELs of the dissociation products, RIVM concluded that dissociation of the substance after oral exposure  will either be at a very low rate, or will not occur at all, and is even more unlikely for dermal and inhalation exposure. 
  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

Endpoint derived based on RIVM decision for Alcamizer P93, dated 23 October 2007, BMS071023.03).

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the Dutch Competent Authority Risk Assessment dated October 23, 2007 (BMS071023.03) of Aluminium-magnesium-zinc-carbonate-

hydroxide (an analogue substance), Aluminium magnesium carbonate hydroxide is of no concern for man and need not be considered further - data currently available are sufficient to allow the notification of this substance above 1000 tonnes/year.

* Aluminium-magnesium-zinc-carbonate-hydroxide (EC no. 423-570-6):

Aluminium-magnesium-zinc-carbonate-hydroxide was tested in a subacute 28-day oral toxicity test (EEC-Directive 92/69 B.7 (according to GLP principles)):

The substance was administered (gavage) to female and male Wistar rats. The dose range was as follows: 0, 50, 200 and 1000 mg/kg bw/day for 28 days - 5 animals per group. No treatment related effect was observed. It was concluded that the NOAEL was 1000 mg/kg bw/day, the highest dose tested.

For chronic toxicity the NOAEL was derived from the NOAEL for Al³⁺ and the content of Al in the substance to be 481 mg/kg bw/d.

Supporting data [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium: 180 days oral gavage repeated dose toxicity test in rats:

NOAEL > 2000 mg/kg/day.

No data is available on dermal or inhalation toxicity.

For the analogue P93 RIVM concluded:

Based on the fact that the NOAEL of 1000 mg/kg bw/d from the 28-d study of the analogue is much higher than the NOAELs of the dissociation products, RIVM concluded that dissociation of the substance after oral exposure will either be at a very low rate, or will not occur at all, and is even more unlikely for dermal and inhalation exposure.

In view of the similar chemical nature and very low water solubility, the same reasoning is applicable to Aluminium magnesium carbonate hydroxide.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Reliable endpoint available for analogue.

Justification for classification or non-classification

Based on the current data for analogues and RIVM conclusion, no classification is needed for systemic toxicity after repeated exposure for

Aluminium magnesium carbonate hydroxide according to Regulation (EC) No 1272/2008.