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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:
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:
other: as mentioned below
Principles of method if other than guideline:
Preliminary irritation tests for test chemical Phenethyl salicylate (CAS No: 87-22-9) were performed in male Albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- IUPAC name: 2-phenylethyl 2-hydroxybenzoate
- Common name: Phenethyl salicylate
- Molecular formula: C15H14O3
- Molecular weight : 242.2726 g/mol
- Smiles notation : c1ccc(cc1)CCOC(=O)c2ccccc2O
- InChl: 1S/C15H14O3/c16-14-9-5-4-8-13(14)15(17)18-11-10-12-6-2-1-3-7-12/h1-9,16H,10-11H2
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- IUPAC name: 2-phenylethyl 2-hydroxybenzoate
- Common name: Phenethyl Salicylate
- Molecular formula: C15H14O3
- Molecular weight : 242.2726 g/mol
- Smiles notation : c1ccc(cc1)CCOC(=O)c2ccccc2O
- InChl: 1S/C15H14O3/c16-14-9-5-4-8-13(14)15(17)18-11-10-12-6-2-1-3-7-12/h1-9,16H,10-11H2
- Substance type:Organic
- Physical state: Solid
- Physical apperance: white crystals

Test animals

Species:
guinea pig
Strain:
other: Albino Dunkin/Hartley
Details on test animals and environmental conditions:
- Weight at study initiation: 320 g (intradermal exposure ) and 450g (dermal exposure )
- Diet (e.g. ad libitum): RGP pellets, hay cabbage ad libitum
- Water (e.g. ad libitum): water ad libitum

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

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:
other: Slightly Irritating
Conclusions:
The test material Phenethyl salicylate (CAS No: 87-22-9) was considered to be slightly irritating on male albino Dunkin/Hartley guinea pigs in the preliminary irritation tests performed for the sensitization study.
Executive summary:

Preliminary irritation tests for test chemicalPhenethyl salicylate(CAS No:87-22-9)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 with0.1ml aliquots of a range of concentration of test substance (0.25%,0.5%, 1% or 2%)in 6% acetone/20% PEG400/0.01% Tween 80/saline.

 

During topical application, animals received a single dermal application of 10%, 25% or 50% phenethyl salicylate 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, thePhenethyl salicylate(CAS No:87-22-9) 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% phenethyl salicylate was selected for the topical induction application.