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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Clinical test performed for cosmetic regulation n°1223/2009 compliance (efficacy claim support) relevant for REACH compliance
Justification for type of information:
Frequently performed cosmetic efficacy assay with human exposure

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Prior to the start of the trials, the initial skin moisture of the test persons (female) was measured with the aid of a Corneometer® which detects the skins moisture retention in the superficial layers of the stratum corneum as deep as 10-20 μm (to be ensured that the measurement is not influenced by capillary blood vessels).
For two weeks, the human applied emulsions with different glycerin:ERYTHRITOL ratios (3:0; 2:1; 1:1; 1:2; 0:3) daily on their right forearm.
Four measure points per test person were determined: one measure point where the skin has not been treated with the emulsion and three measure points where the skin has been treated with the emulsion.

The main purpose of this study is to determine the ability of the substance to hydrate human skin, as part of a cosmetic test. The authors of the study the authors of the study also evaluate the skin irritation potential of the substance. Given the animal model used (human) and the duration of the test (2 weeks), it can be considered reliable in assessing the potential for irritation of the skin by erythritol
GLP compliance:
not specified
Remarks:
Clinical test performed for cosmetic regulation n°1223/2009 compliance (efficacy claim support) relevant for REACH compliance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
different glycerin:ERYLITE® ratios (3:0; 2:1; 1:1; 1:2; 0:3)
Specific details on test material used for the study:
different glycerin:Erythritol ratios (3:0; 2:1; 1:1; 1:2; 0:3) then between 25% and 75%

Test animals

Species:
other: human
Details on test animals and environmental conditions:
healthy female test persons of different age and different skin type

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
other: glycerin
Controls:
yes, concurrent vehicle
yes, concurrent negative control
Amount / concentration applied:
0%, 33%, 50%, 66%, 100%
Duration of treatment / exposure:
daily, for 2 weeks on their right forearm
Number of animals:
10 persons per glycerin:Erythritol ratios (3:0; 2:1; 1:1; 1:2; 0:3)
Details on study design:
For statistical reasons four measure points per test person were determined: one measure point where the skin has not been treated with the emulsion and three measure points where the skin has been treated with the emulsion.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
14 d
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
People who are sensitive or allergic to certain chemical components can have skin irritation, rashes or other allergic reactions when getting in contact with certain substances. None of the 80 test persons having Erythritol on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.
Other effects:
moisturizing effect

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Erythritol has proven to have a very good skin compatibility and can be considered as non-irritant.
Executive summary:

In a clinical test in 80 humans, Erythritol has proven to have a very good skin compatibility and can be considered as non-irritant.