Registration Dossier

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
605 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 (8.6%) were used to calculate the NOAEL for Magnesium-aluminium-hydroxide-carbonate. The same approach as for Alcamizer P93 was used to derive the endpoint, i.e. Al-NOAEL *100/Al content. In the RIVM decision, magnesium ions are stated to be not toxic to fertility.


Short description of key information:
NOAEL 605 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 151 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
151 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 (8.6%) were used to calculate the NOAEL for Magnesium-aluminium-hydroxide-carbonate. 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 605 mg/kg bw/d for fertility and a NOAEL of 151 mg/kg bw/d for developmental toxicity. The substance is not teratogenic.

Justification for classification or non-classification

In the absence of effects on fertility or developmental toxicity for the analogues, no classification is needed for Magnesium-Aluminium-Hydroxide-Carbonate.