3-phenylpropyl acetate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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

Species:

human

Strain:

other: not applicable

Sex:

male

Details on test animals and environmental conditions:

- Age at study initiation: Adult

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

8% (5520 µg/cm2)

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

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..

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization

Various studies were performed for test chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) to observe its sensitization potential that have been summarized as below;

G. Klecak (1985), D. McGinty, C.S. Letizia, A.M. Api (2012) and 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 (2012) reported skin sensitization tests for target substance 3- Phenylpropyl acetate (CAS No: 122-72-5) in humans and guinea pigs via human maximization test and open epicutaneous test respectively as follows;

 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.

An open epicutaneous test was conducted on 6-8 guinea pigs in which   0.1 mL of 3- phenylpropyl acetate at concentrations of 100%, 30%, 10%, 3%, 1%, or 0.3% was applied daily for 3 weeks with the site uncovered. Following induction, the animals were challenged on days 21 and 35 with 0.025 mL of 8% 3-phenyl propyl acetate. The sites were scored 24, 48 and 72 h after exposure. None of the test animals elicit sensitization effects at challenge concentration, hence the test chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) is not-sensitizing to the skin of guinea pigs.

According to Danish (Q) SAR Database 2016, the sensitization effects were observed for target 3- Phenylpropyl acetate (CAS No: 122-72-5) in guinea pig and human. Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be non-sensitizer on guinea pig and human for 3- Phenylpropyl acetate (CAS No: 122-72-5) . Thus it can be concluded that the substance 3- Phenylpropyl acetate (CAS No: 122-72-5) has negative skin sensitization effects.

The available data for test chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) suggests that the test chemical is unlikely to cause skin sensitization and thus can be classified as non-skin sensitizer.

Migrated from Short description of key information:

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.

Justification for selection of skin sensitisation endpoint:

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

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) was observed in various studies. From the results obtained from these studies it is concluded that the chemical 3- Phenylpropyl acetate (CAS No: 122-72-5) was unable to cause skin sensitization and hence can be classified as non-skin sensitizer.