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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
As the RIVM decision was made for a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.

Data source

Reference
Reference Type:
other: Dutch Competent Authority Risk Assessment
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Principles of method if other than guideline:
Based on toxicity data of aluminium, zinc and magnesium RIVM has derived a NOAEL for Aluminium-magnesium-zinc-carbonate-hydroxide. The NOAEL for Aluminium-magnesium-zinc-carbonate-hydroxide was based on that of zinc. For magnesium aluminium hydroxide carbonate the NOAEL was based on the NOAEL of Al3+ of 52 mg/kg bw/d resulting in a NOAEL of 605 mg/kg bw/d (using Al-content 8.6%). See also RIVM decision Chapter 13.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
-
EC Number:
423-570-6
EC Name:
-
IUPAC Name:
423-570-6
Constituent 2
Reference substance name:
169314-88-9
EC Number:
605-549-5
Cas Number:
169314-88-9
IUPAC Name:
169314-88-9

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
605 mg/kg bw/day (actual dose received)
Basis for effect level:
other: Based on NOAEL of Al3+ and Al-content.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion