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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, however not sufficient for C & L as only two parameters were obsersed at 72 hr.

Data source

Reference
Reference Type:
publication
Title:
Comparative studies on the irritancy of oils and synthetic perfumes to the skin of rabbits, guinea pigs, rat, miniature swine and man.
Author:
Mototoshi K, Toyoshima Y, Sato M, Yoshimura M
Year:
1979
Bibliographic source:
Cosmetics and Toiletries.94(8).41-43

Materials and methods

Principles of method if other than guideline:
From a large number of cosmetic raw materials, 39 test compounds (19 oils and 20 synthetic perfumes (which include Phenylethyl alcohol) were chosen to perform irritancy potential in Japan.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity:> 98%

Test animals

Species:
rabbit
Strain:
Angora
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing:Animals were maintained in individual stainless steel cages
- Weight at study initiation:2.3 to 3.0 kg (average weight 2.6 kg)
- Diet (e.g. ad libitum):Food were permitted
- Water (e.g. ad libitum):Water were permitted

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
other: Yes. Hexadecane was reagent grade and used as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied :0.1 g of 100% test compound



Duration of treatment / exposure:
24 hours then second exposure for 30 min.
Observation period:
24 hr and at 72 hr
Number of animals:
6 animals in the treatment group and the control
Details on study design:
TEST SITE
- Area of exposure:The hair on a area of the dorsal surface of each animal was clipped as close to the skin as possible using an electric clipper.The test areas measured 3 x 3 cm and were approximately 2 cm apart
- Type of wrap if used:A 25 cm diameter plastic collar was wrapped around the neck of each rabbit


SCORING SYSTEM: See table 1 for details

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
2
Reversibility:
no data

Any other information on results incl. tables

The dilating rate of blood vessels, the swelling rate (edema), the bluing rate (as a result of increased capillary permeability), and the bleeding rate on the test sites were read using transmitting light. The total score of the averages of the reddening rate ( erythema, 72 hr reading), the dilating rate, the swelling rate, and the bluing rate for 6 animals in a group was referred to as the primary irritation index.

Table 2. Relative irritancy of 100 and 32 % concentrations of test compounds (synthetic perfumes) in the skin of rabbit

Compound

Rabbit (100%)

Phenyl ethyl alcohol

2

Scoring : 0 = negative, 1= mildly irritating, 2= moderately irritating, 3= severely irritating

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: See any other information on f materials and methods iclu.tables
Conclusions:
Phenyl ethyl alcohol was concluded as moderately irritant.