[carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium

Repeated dose toxicity: oral

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

Test material information

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