Magnesium 2,3,4,5,6,7-Hexahydroxyheptanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented peer-reviewed report.

Data source

Reference

Reference Type:

publication

Title:

Final Report of the Safety Assessment of L-Ascorbic Acid, Calcium Ascorbate, Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate, and Sodium Ascorbyl Phosphate as Used in Cosmetics.

Author:

CIR (Cosmetic Ingredient Review)

Year:

2005

Bibliographic source:

International Journal ofToxicolgy. 24 (Suppl. 2): 51-111, 2005.

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

The report describes results of dermal application of creams containing Magnesium Ascorbyl Phosphate to prevent scurvy and dark pigmentation in guinea pigs and humans, respectively. The report concludes safety use of L-ascorbic acid and its magnesium, calcium and sodium salts in cosmetic products.

GLP compliance:

no

Type of study:

other: dermal application of cream containing magnesium ascorbyl phosphate to guinea pigs and humans.

Justification for non-LLNA method:

The study was conducted prior LLNA became as standard information requirement.

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium ascorbate

IUPAC Name:

Magnesium ascorbate

Constituent 2

Reference substance name:

Magnesium Ascorbyl Phosphate

IUPAC Name:

Magnesium Ascorbyl Phosphate

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: Evaluation of skin sensitisation potential of magnesium compounds in cosmetic formulations.

Group:

test chemical

Dose level:

Cosmetic formulations: 7.5 to 30.0 mg/day/animal or 10 % cream (humans/day)

No. with + reactions:

0

Total no. in group:

34

Clinical observations:

No overt skin reactions related to sensitisation

Remarks on result:

other:

Remarks:

Magnesium salts of ascorbic acid (Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate) are evaluated to be safe as used in cosmetic products. The Panel concluded that these magnesium salts are not sensitizing in human subjects.

Any other information on results incl. tables

Imai et al. (1967) administered either a stock diet or a scorbutigenic diet and water ad libitum for 10 days to male guinea pigs. Guinea pigs fed the scorbutigenic diet were divided into groups after the 10-day feeding period and were percutaneously given Ascorbic Acid at doses from 3.5 to 14.0 mg/day or Magnesium Ascorbyl Phosphate at doses from 7.5 to 30.0 mg/day, both in a cream. The cream was applied on the clipped skin of the back just posterior to the neck. The cream base consisted of cetyl alcohol 3%, hydrogenated lanolin 4%, vegetable oil such as olive oil 3%, isopropyl myristate 6%, polyethylene glycol 6%, nonionic surface-active agents such as polyoxyethylene stearate and glycerol monostearate 16%, and preservatives. One-third the daily dose of the cream was applied at 8 AM, 12 PM, and 4 PM. After application the animals were observed. The L-Ascorbic Acid dose of 7 mg/animal/day (0.5 g cream/ day) and 15 mg/animal/day of Magnesium Ascorbyl Phosphate (0.5 g cream/day) prevented the development of scurvy; the activity of Magnesium Ascorbyl Phosphate was somewhat weaker than that of L-Ascorbic Acid. Sixteen hours after the last application of cream, the skin of the back (treated) and of the abdomen (non-treated) were examined microscopically. The applied skin of the backs in the treated groups indicated the existence of Ascorbic Acid in the intercellular space of the epithelium, contrasting with the absence of Ascorbic Acid in the control group and in the skin of the abdomen in all groups (Imai et al. 1967).

Magnesium Ascorbyl Phosphate Magnesium Ascorbyl Phosphate (VC-PMG) cream (10%) was applied twice a day to the skin of 34 patients with ephelides, chloasma, senile freckles, nevus of Ota, or healthy skin. The effectiveness of the lightening of the pigmentation was judged by a color-difference meter. The VC-PMG cream was effective or fairly effective in 19 of 34 patients. VC-PMG cream applied to the healthy skin of 25 patients resulted in 1 effective, 2 fairly effective, 8 slightly effective, 12 not effective, and 2 possible darkenings (Kameyama et al. 1996).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Magnesium salts of ascorbic acid (Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate) are evaluated to be safe as used in cosmetic products. The Panel concluded that these magnesium salts are not sensitizing in human subjects.

Executive summary:

Magnesium Ascorbate is described as antioxidant and skin conditioning agent and Magnesium Ascorbyl Phosphate is an antioxidant in cosmetic products. The concentration of use in cosmetics is reported to be in the range of 0.001 -3%.

Magnesium Ascorbyl Phosphate (7.5 to 30 mg/animal/day (= 0.5 g cream/day)) administered dermally, prevented the development of scurvy in guinea pigs fed by scorbutigenic diet. No skin sensitisation reactions were reported due to the administration of this magnesium salt in treated animals. Magnesium Ascorbyl Phosphate (10 % as lightening cream) was tested in patients with different skin disorders and in healthy patients. No skin sensitization reactions were reported.

Because of the structural and functional similarities of the ingredients: L-Ascorbic Acid, Calcium Ascorbate, Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate, and Sodium Ascorbyl Phosphate, the Panel believes that the data on one ingredient can be extrapolated to all of them.