2-phenylethanol

Skin sensitisation

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

Test material information

Constituent 1

Reference substance name:

2-phenylethanol

EC Number:

200-456-2

EC Name:

2-phenylethanol

Cas Number:

60-12-8

Molecular formula:

C8H10O

IUPAC Name:

2-phenylethanol

In vivo test system

Test animals

Species:

human

Strain:

not specified

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

8 % DEP

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

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 chemical

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..