Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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

Referenceopen allclose all

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 Type:
publication
Title:
Gluconic Acid and its Derivatives. CAS N°: Gluconic Acid, 526-95-4 Glucono-Delta-Lactone, 90-80-2 Sodium Gluconate, 527-07-1 Calcium Gluconate, 299-28-5 /18016-24-5 Potassium Gluconate, 299-27-4
Author:
OECD SIDS
Year:
2004
Bibliographic source:
UNEP PUBLICATIONS: SIDS Initial Assessment Report For SIAM 18 Paris, France, 20-23 April 2004 (available via www.inchem.org/documents/sids/sids/gluconates.pdf, 2015-07-15)

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:
This is a summary result based on several animal and human data.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: cosmetic formulations

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: Mono- and disaccharides did not produe 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 produe 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
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
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 are lacking; however, based on the clinical experience of the Panel, there is little concern that these ingredients are irritants or sensitizers".