Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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:
according to
Guideline:
other: refer to article
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
human
Strain:
other: human

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: Diethyl phthalate, Alcohol SD-39C, Alcohol 52
Amount / concentration applied:
Diethyl phthalate: 8%
Alcohol SD-39C: 25%
Alcohol 52: 25%

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
108
Reversibility:
fully reversible
Remarks on result:
other: 8% solution in Diethyl Phthalate
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
52
Max. score:
93
Reversibility:
fully reversible
Remarks on result:
other: 25% solution in Alcohol SD-39C
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
19
Max. score:
50
Reversibility:
fully reversible
Remarks on result:
other: 25 % solution in Ethanol. 16 of 19 volunteers only showed signs of slight erythema. 3 of 19 individuals showed a well defined erythema confined to the contact site.

Applicant's summary and conclusion