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Toxicological information

Skin sensitisation

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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

Referenceopen allclose all

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 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 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

Constituent 1
Reference substance name:
3- Phenylpropyl acetate
IUPAC Name:
3- Phenylpropyl acetate
Constituent 2
Chemical structure
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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% (5520 µg/cm2)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
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.