Phenethyl salicylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Preliminary irritation tests for test chemical were performed in male Albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl salicylate

EC Number:

201-732-5

EC Name:

Phenethyl salicylate

Cas Number:

87-22-9

Molecular formula:

C15H14O3

IUPAC Name:

phenethyl salicylate

Test material form:

solid

Details on test material:

Name: Phenethyl salicylate
Molecular Formula: C15H14O3
Molecular Weight: 242.2726 g/mol
SMILES: c1ccc(cc1)CCOC(=O)c2ccccc2O
Substance Type: Organic
Physical State: Solid

Test animals

Species:

guinea pig

Strain:

other: Albino Dunkin/Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No Data Available
- Age at study initiation: No Data Available
- Weight at study initiation: 400-500 grams 320 g (intradermal exposure ) and 450g (dermal exposure )
- Housing: No Data Available
- Diet (e.g. ad libitum): RGP pellets, hay cabbage ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No Data Available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No Data Available
- Humidity (%): No Data Available
- Air changes (per hr): No Data Available
- Photoperiod (hrs dark / hrs light): No Data Available

IN-LIFE DATES: From: To: No Data Available

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Intradermal application: clipped flanks Dermal application: shaved flanks

Vehicle:

other: Intradermal application: 6% acetone/20% PEG400/0.01% Tween 80/saline Dermal application: acetone

Controls:

not specified

Amount / concentration applied:

Intradermal concentration: 0.25 %,0.5%, 1% or 2%
Topical Concentration: 10%, 25 % or 50%

Duration of treatment / exposure:

Single application

Observation period:

24 and 48 hours

Number of animals:

4 (same sex)

Details on study design:

Area of exposure: shaved flanks
- % coverage: 8mm diameter filter paper patches in 11mm aluminum patch test cups are saturated with a range of concentrations of test chemical.
- Type of wrap if used: the patches are held in place by adhesive plaster ound around the trunk.
- Time after start of exposure: 24 and 48 hours after removal of the patches.
SCORING SYSTEM: the resulting reactions are scored for irritation on a scale from 0 to +++. (mentioned in table 1)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48 h

Reversibility:

not specified

Remarks on result:

other: Very slight erythema was observed at 0.25% and 0.5% . Barely perceptible erythema was observed at 10%, 25% or 50% concentrations

Irritant / corrosive response data:

Very slight erythema was observed at 0.25% and 0.5% . Barely perceptible erythema was observed at 10%, 25% or 50% concentrations

Other effects:

No Data Available

Any other information on results incl. tables

Table 1.Skin Reaction Scoring System
SKIN REACTIONS	SCORES
No reaction	0
Barely perceptible erythema	±
Scattered, mild erythema (faint pink)	+
Moderate and diffuse erythema (pale pink )	++
Intense erythema (deep pink) and oedema	+++

Table 2: RESULTS OF PRELIMINARY IRRITATION TEST
Guinea pigs		Concentrations
No.	Sex	10%		25%		50%
		24 hr	48 hr	24 hr	48 hr	24 hr	48 hr
1	M	0	0	±	±	±	±
2	M	0	0	0	0	±	±
3	M	±	0	±	±	±	+
4	M	0	0	±	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on the observations and results, it was concluded that the test material was considered to be slightly irritating (Category 2) on male albino Dunkin/Hartley guinea pigs in the preliminary irritation tests performed for the sensitization study.

Executive summary:

A Preliminary irritation tests for test chemical were performed on male albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study. In the preliminary test, the guinea pigs were treated intradermally and dermally. The animals were intradermally injected with 0.1ml aliquots of a range of concentration of test substance (0.25%,0.5%, 1% or 2%) in 6% acetone/ 20% PEG 400 /0.01% Tween 80/ saline. During topical application, animals received a single dermal application of 10%, 25% or 50% test chemical in acetone using 8 mm saturated filter paper and 11 mm aluminum patch test cups which were applied to the shaved flank for 24 h. Reactions were assessed for irritation at 24 and 48 h after patch removal. Very slight erythema was observed at 0.25% and 0.5%. Barely perceptible erythema was observed at 10%, 25% or 50% concentrations. Since the test chemical induced cutaneous effects at these concentrations, the test chemical was considered to be slightly irritating to the skin of albino Dunkin/Hartley guinea pigs. Thus concentration of 0.5% was selected for the intradermal induction and a concentration of 50% the test chemical was selected for the topical induction application. Based on the observations and results, it was concluded that the test material was considered to be slightly irritating (Category 2) on male albino Dunkin/Hartley guinea pigs in the preliminary irritation tests performed for the sensitization study.