Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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 reports.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Safety Assessment of Monosaccharides, Disaccharides, and Related Ingredients as Used in Cosmetics

Author:

CIR (Cosmetic Ingredient Review)

Year:

2014

Bibliographic source:

Cosmetic Ingredient Review; Final Report Release Date: April 4, 2014; Panel Meeting Date: March 17-18, 2014

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Summary of sensitization study results (non-human and human) conducted with monosaccharides, disaccharides, and related Ingredients as used in cosmetics.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

The REACH Regulation, Annex VII, paragraph 8.3 states "The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another test shall be provided." These non-human and human sensitisation study results are already available and their use is considered in the view of its relevance for the toxicological evaluation of iron glucoheptonate.

Test material

Test material information

Constituent 1

Reference substance name:

mono- and disaccharides, gluconic acid and its derivatives

IUPAC Name:

mono- and disaccharides, gluconic acid and its derivatives

Test material form:

other: cosmetic formulations

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: Mono- and disaccharides did not produce hypersensitivity skin reactions when tested in animals and In human repeated insult patch tests (HRIPTs).

Remarks on result:

other: Reading: other: Mono- and disaccharides did not produce hypersensitivity skin reactions when tested in animals and In human repeated insult patch tests (HRIPTs)..

Any other information on results incl. tables

A face and neck formulation containing 2.48% lactose did not produce irritation or hypersensitivity in a 4-wk safety-in use ophthalmological evaluation. Thirty-one subjects participated in the study.

In non-human studies, a 50% aq. solution of gluconic acid was not a dermal irritant and lactitol was not an irritant or sensitizer in rabbits. In human repeated insult patch tests (HRIPTs), formulations containing 10% rhamnose, up to 8% glucose, 5% mannose, 2.48% lactose, and less than 1% isomalt, kefiran, lactitol, sucralose, and xylobiose were not irritants or sensitizers. A formulation containing 10% rhamnose did induce a significant irritation reaction in one subject, and irritation was observed in 16% of the subjects during induction in an HRIPT of a rinse-off hair product containing 29% sucrose (tested as a 50% dilution); no sensitization reactions were reported for this product.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

Calcium gluconate and gluconic acid, structurally similar anlogues to glucoheptonates, have been assessed by the Panel as non-sensitizers in cosmetic formulations.

Executive summary:

"The Panel acknowledged that sucrose and glucose are used in cosmetics at relatively high concentrations, and that data from irritation and sensitization studies at maximum use concentrations of these ingredients (i.e. calcium gluconate and gluconic acid) are lacking; however, based on the clinical experience of the Panel, there is little concern that these ingredients are irritants or sensitizers".