3-phenylpropyl acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Dta is from publication

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The Freund's Complete Adjuvant Test and the Open Epicutaneous Test

Author:

G. Klecak

Year:

1985

Bibliographic source:

Curr. Probl. Derm., vol.14, pp.152-171 (Karger, Basel 1985)

Reference 2

Reference Type:

publication

Title:

Fragrance material review on 3-phenylpropyl acetate

Author:

D. McGinty, C.S. Letizia, A.M. Api

Year:

2012

Bibliographic source:

Food and Chemical Toxicology 50 (2012) S457–S461

Reference 3

Reference Type:

publication

Title:

A toxicological and dermatological assessment of aryl alkyl alcohol simple acid ester derivatives when used as fragrance ingredients

Author:

The RIFM Expert Panel - D. Belsito, D. Bickers, M. Bruze, P. Calow, M.L. Dagli, A.D. Fryer,H. Greim, Y. Miyachi, J.H. Saurat, I.G. Sipes

Year:

2012

Bibliographic source:

Food and Chemical Toxicology 50 (2012) S269–S313

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Maximization test was conducted on human to determine skin sensitisation of chemical 3- Phenylpropyl acetate.

GLP compliance:

not specified

Type of study:

other: Human Maximization test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3- Phenylpropyl acetate

IUPAC Name:

3- Phenylpropyl acetate

Constituent 2

Reference substance name:

3-phenylpropyl acetate

EC Number:

204-569-8

EC Name:

3-phenylpropyl acetate

Cas Number:

122-72-5

Molecular formula:

C11H14O2

IUPAC Name:

3-phenylpropyl acetate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 3- Phenylpropyl acetate- Molecular formula: C11H14O2- Molecular weight: 178.23 g/mol- Substance type: Organic- Physical state: Liquid- Smiles: c1(CCCOC(C)=O)ccccc1-InChI: 1S/C11H14O2/c1-10(12)13-9-5-8-11-6-3-2-4-7-11/h2-4,6-7H,5,8-9H2,1H3

In vivo test system

Test animals

Species:

human

Strain:

other: not applicable

Sex:

male

Details on test animals and environmental conditions:

- Age at study initiation: Adult

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Induction 2

Concentration / amount:

8% (5520 µg/cm2)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

8% (5520 µg/cm2)

No. of animals per dose:

25 volunteers

Details on study design:

A. INDUCTION EXPOSURE- No. of exposures: for five alternate days- Exposure period: 48 h periods.- Test groups:25- Control group: No data- Site:Forarms- Frequency of applications: for five alternateday, 48 h periods- Duration:5 days- Concentrations:8% in petrolatumB. CHALLENGE EXPOSURE- No. of exposures:- Day(s) of challenge: 10 days after challenge exposure period- Exposure period:48-hrs- Test groups:25 - Control group: No data- Site: applied to different site.- Concentrations: 8 % in petrolatum- Evaluation (hr after challenge): Scoring was done upon patch removal and 24 h thereafter

Challenge controls:

no data

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

8%

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

Non sensitizing effects were observed after patch removal and 24 hours.

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 8%. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: Non sensitizing effects were observed after patch removal and 24 hours..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Non-sensitizing effects were known in maximisation test of chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) exposed to 25 human volunteers.

Executive summary:

 A Human maximization test was carried out in 25 adult male patients to assess the sensitization potential of 3- Phenylpropyl acetate (CAS No: 122-72-5).

 

In the induction phase of a maximization study,an 8% (5520 µg/ cm2) concentration of 3-phenylpropyl acetate was applied under occlusion for five alternate day, 48 h periods to the forearm of 25 adult male patients. Following a 10 day rest period, a challenge concentration of 8% 3-phenylpropyl acetate was applied under occlusion for 48 h to a different site. The induction application was preceded by a 24 h treatment with 5% sodium lauryl sulfate and the challenge dose was preceded by a 1 h application of 10% sodium lauryl sulfate. Scoring was done upon patch removal and 24 h thereafter.

 

Since non sensitizing effects were observed after 24 hours in all the patients, the test chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) was considered to be non-sensitizing on human skin.