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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
clinical study
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2011
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

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 bycapillary 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
Type of study:
open epicutaneous test
Justification for non-LLNA method:
LLNA assay not avaialble, but clinical data used in a weight of evidence approach with sensitization data

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%

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: glycerin
Concentration / amount:
25 to 75%
Day(s)/duration:
daily for 2 weeks
Adequacy of challenge:
other: up to 75% (non irritating substance)
No. of animals per dose:
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.
Challenge controls:
see above
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test group
Dose level:
25 to 75%
No. with + reactions:
0
Total no. in group:
80
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
not measured/tested
Remarks:
clinical test on volunteers to support substance safety and efficacy: no negative/control group
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
clinical test on volunteers to support substance safety and efficacy: no negative/control group

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
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 (at 25% and up to 75%) on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.
Executive summary:

In a clinical open test in 80 volunteers, application onto forearm of women. 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 (at 25% and up to 75%) on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.