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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
human patch test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Version / remarks:
Cosmetic product test guidelines for the assissment of human skin compatibility. colifa pubblication - November 1995
Principles of method if other than guideline:
The method consists in a occlusive application of the products by means of Finn Chamber (aluminium cells of 20 microL volume) on 20 selected subjects' back or forearm. The irritating activity is clinically evaluated: 30 min after application (immediate irritative power); 48 hours later; by observing check made 24 hours after the removal of the plaster strip. Product are then ranked on a statment scale ranging of the irritating reaction observed as well as their frequency in the different subjects.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
the LLNA method is next to the study

Test material

Constituent 1
Chemical structure
Reference substance name:
Escin
EC Number:
229-880-6
EC Name:
Escin
Cas Number:
6805-41-0
Molecular formula:
C110H172O48
IUPAC Name:
(2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-[(2-methylbutanoyl)oxy]-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid; (2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-{[(2E)-2-methylbut-2-enoyl]oxy}-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid
Test material form:
solid

In vivo test system

Test animals

Species:
other: human
Strain:
other: Caucasian race. Adults aged 18-65
Sex:
male/female

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
0.5
Group:
test chemical
Dose level:
the escin was put in Finn Chambers, aluminium cells with a diameter of 8mm, 50 mm2 arrea, volume 20 microL, directly into the cells, filled slightly more than half their volume
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
irritated case
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
the escin was put in Finn Chambers, aluminium cells with a diameter of 8mm, 50 mm2 arrea, volume 20 microL, directly into the cells, filled slightly more than half their volume
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
irritated case
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: None of the subjects reported itching phenomena