Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
test on human volunteers
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Chamber Scarification Test (1)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-hexylresorcinol
EC Number:
205-257-4
EC Name:
4-hexylresorcinol
Cas Number:
136-77-6
Molecular formula:
C12H18O2
IUPAC Name:
4-hexylresorcinol

Test animals

Species:
other: human

Test system

Type of coverage:
occlusive
Preparation of test site:
other: scratched
Vehicle:
other: Petrolatum
Controls:
yes, concurrent negative control
Amount / concentration applied:
Amount: 0.1 ml, Concentration: 0.1% and 0.5%
Duration of treatment / exposure:
24h, for 3 days
Number of animals:
10
Details on study design:
The test material was applied on Day 1, Day 2, and Day 3 on the same scarified skin site on the forearm of each participant. After each 24 h of contact, the test material was removed. 30 min after each removal, the skin site was examined and graded.An identical procedure was conducted concurrently using physiological saline on an additional site.

Results and discussion

In vivo

Results
Remarks on result:
other: it was not an in vivo test on animals, but on hunman volunteer

Any other information on results incl. tables

Test material identification Irr. Index Potential

Saline 0.55 low

Sample 0.1% 0.55 low

Sample 0.5% 0.65 low

Applicant's summary and conclusion

Conclusions:
At the end of 72 h, the effect of Sample 0.1% on scarified skin were equal to the saline control, on those of Sample 0.5% on scarified skin were slightly greater than those of the saline control.