Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
review article or handbook
Title:
Fragrance material review on phenethyl alcohol
Author:
J.Scognamiglio, et al.
Year:
2011
Bibliographic source:
Food and chemical toxicology, doi: 10.1016/j.fct2011.10.028

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: according to review
Deviations:
not specified
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8 % DEP
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8 % DEP
No. of animals per dose:
108 human volunteers
Details on study design:
Tests were conducted to determine if phenethyl alcohol would induce dermal sensitization in human volunteers. During the induction phase, 0.2-0.3 ml of phenethyl alcohol was applied onto an occlusive patch and applied to the upper arm or back of each volunteer for 24 or 48 h. Induction applications were made to the same site on Monday, Wednesday and Friday for a total of of nine applications during a 3-week period. Following a 10-to14 day rest period, a challenge patch was applied to the site previously unexposed. Patches were applied as in the induction phase and kept in place for 24 h before removal. Reactions to the challenge were scored at 24, 48 and/or 72 h after application.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.3 ml 8% in DEP
No. with + reactions:
2
Total no. in group:
108
Clinical observations:
One subject displayed mild erythema and one subject exhibited a strong to moderate response to both test material and solvent control during induction.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 ml 8% in DEP. No with. + reactions: 2.0. Total no. in groups: 108.0. Clinical observations: One subject displayed mild erythema and one subject exhibited a strong to moderate response to both test material and solvent control during induction..

Applicant's summary and conclusion