Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

Endpoint:
additional toxicological information
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Official US FDA notification.

Data source

Reference
Reference Type:
publication
Title:
Notification Pursuant to Section 6 of DSHEA and C.F.R. § 101.93
Author:
US FDA
Year:
2004
Bibliographic source:
http://www.fda.gov/.../97s-0162-let13715-vol116.pdf

Materials and methods

Type of study / information:
US FDA Notification
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Magnesium gluconate is notified as a dietary ingredient (supplement).
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Magnesium gluconate
IUPAC Name:
Magnesium gluconate
Constituent 2
Chemical structure
Reference substance name:
Magnesium digluconate
EC Number:
222-848-2
EC Name:
Magnesium digluconate
Cas Number:
3632-91-5
Molecular formula:
C6H12O7.1/2Mg
IUPAC Name:
magnesium bis(2,3,4,5,6-pentahydroxyhexanoate) (non-preferred name)

Results and discussion

Any other information on results incl. tables

This notification is being filed on behalf of Neways, Inca, 2089 Neways Drive, Springville, UT 84663, which is the manufacturer of the, product, which bears the statements identified in the Notification. This Notification is being made pursuant to Section 6 of DSHEA and Rule 21 C.F.R. $ 101.93. The dietary supplement product on whose label or labeling statements appears is Maxim01 Solutions@ (Blueberry).

Magnesium gluconate is mentioned as a dietary ingredient, for which a statement has been made.

Applicant's summary and conclusion

Conclusions:
Magnesium gluconate is notified as a dietary ingredient (supplement).