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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
Read across from the RIVM decision from 23 October 2007(BMS071023.03) for Aluminium-magnesium-zinc-carbonate-hydroxide (EC 423-570-6).
Effect on fertility: via oral route
Dose descriptor:
NOAEL
481 mg/kg bw/day
Additional information

Based on the RIVM decision from October 23, 2007 (BMS071023.03) for analogue Alcamizer P93 (Aluminium-magnesium-zinc-carbonate-hydroxide, EC no. 423-570-6), the available data for the aluminium ion (NOAEL AL3+ >52 mg/kg bw/d) and the Al content of the registered substance (10.8%) were used to calculate the NOAEL for Aluminium magnesium carbonate hydroxide. The same approach as for Alcamizer P93 was used to derive the endpoint, i.e. Al-NOAEL *100/Al content resulting in a NOAEL of 481 mg/kg bw/d for fertiity. In the RIVM decision, magnesium ions are stated to be not toxic to fertility.

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, including NOAELs for reprotoxicity, 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.


Short description of key information:
NOAEL 481 mg/kg bw/d (in analogy to RIVM decision for Alcamizer P93, dated 23 October 2007, BMS071023.03)

Effects on developmental toxicity

Description of key information
NOAEL 120 mg/kg bw/d (in analogy to RIVM decision for Alcamizer P93, dated 23 October 2007, BMS071023.03)
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
120 mg/kg bw/day
Additional information

RIVM decision for Alcamizer P93, dated 23 October 2007, BMS071023.03)

Based on the RIVM decision from October 23, 2007 (BMS071023.03) for analogue Alcamizer P93 (Aluminium-magnesium-zinc-carbonate-hydroxide, EC no. 423-570-6), the available data for the aluminium ion (NOAEL AL3+ <13 mg/kg bw/d) and the Al content of the registered substance (10.8%) were used to calculate the NOAEL for Aluminium magnesium carbonate hydroxide.

The same approach as for Alcamizer P93 was used to derive the endpoint, i.e. Al-NOAEL *100/Al content resulting in a NOAEL of 120 mg/kg bw/d for developmental toxicity. The substance is not teratogenic. 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, including NOAELs for developmental toxicity, 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.

Justification for classification or non-classification

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. Therefore, the substance does not need to be classified.

Following the same reasoning, no classification is needed for Aluminium magnesium carbonate hydroxide.

Additional information