3-phenylpropionyl chloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

Fragrance material review on benzyl acetate

Author:

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

Year:

2012

Bibliographic source:

Food and Chemical Toxicology 50 (2012) S363–S384

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

A guinea pig maximization test according to the Magnusson and Kligman (1969) was conducted in 20 Hartley albino guinea pigs to study the skin sensitization potential of Benzyl acetate.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl acetate

EC Number:

205-399-7

EC Name:

Benzyl acetate

Cas Number:

140-11-4

Molecular formula:

C9H10O2

IUPAC Name:

benzyl acetate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Benzyl acetate- Molecular formula (if other than submission substance): C9H10O2- Molecular weight (if other than submission substance): 150,18 g/mol- Substance type: Organic- Physical state: Liquid- Purity : No data available- Impurities (identity and concentrations): No data available

Specific details on test material used for the study:

- Name of test material (as cited in study report): Benzyl acetate- Molecular formula (if other than submission substance): C9H10O2- Molecular weight (if other than submission substance): 150,18 g/mol- Substance type: Organic- Physical state: Liquid- Purity : No data available- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

petrolatum

Concentration / amount:

10% Intradermal, 30% dermal in petrolatum

Day(s)/duration:

6 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

other: Dermal

Vehicle:

petrolatum

Concentration / amount:

1%, 3% or 10% in petrolatum

Day(s)/duration:

on day 7

Adequacy of challenge:

not specified

No. of animals per dose:

20 guinea pigs

Study design: in vivo (LLNA)

Details on study design:

RANGE FINDING TESTS:MAIN STUDYA. INDUCTION EXPOSURE (1)- No. of exposures: six injections- Exposure period: No data available- Test groups: yes- Control group: yes- Site: No data available- Frequency of applications: daily once - Duration: 6 days- Concentrations: 10% IntradermalA. INDUCTION EXPOSURE (2)- No. of exposures: six injections- Exposure period: 48 h- Test groups: yes- Control group: yes - Site: No data available- Frequency of applications: no data available- Duration: on day 7 or 8- Concentrations: 0.8 mL of 30% dermalB. CHALLENGE EXPOSURE- No. of exposures: - Day(s) of challenge: On day 19 or 21- Exposure period: 24 h- Test groups: yes- Control group: yes- Site: No data available- Concentrations: 1%, 3% or 10% in petrolatum- Evaluation (hr after challenge): at 24 and48 h afterOTHER: Control animals received intradermal injections of 50% FCA in distilled water, undiluted saline or 50% saline in FCA followed by dermal application of 0.8 mL of petrolatum. The control group received 10% benzyl acetate in petrolatum.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1%, 3% or 10% of benzyl acetate in petrolatum

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

There was no incidence of sensitization at any concentrations.

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1%, 3% or 10% of benzyl acetate in petrolatum

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

There was no incidence of sensitization at any concentrations.

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Summary of guinea pig sensitization studies

Method	Induction concentration	Challenge concentration	Reactions
Maximiza tion	10% Intradermal, 30% dermal in petrolatum	1%, 3% or 10% in petrolatum	0/20 No sensitization

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

There was no incidence of sensitization at any concentration of benzyl acetate. Thus on the basis of negative skin reaction it can be concluded that the benzyl acetate is not a skin sensitizer.

Executive summary:

A guinea pig maximization test according to the Magnusson and Kligman was conducted in 20 Hartley albino guinea pigs.

In the induction phase of the study, test animals received two intradermal injections each of 0.1 mL of 50% Freund’s complete adjuvant (FCA) in distilled water; 10% benzyl acetate in saline; and 10% benzyl acetate in FCA, for a total of six injections. On day 7 or 8, 0.8 mL of 30% benzyl acetate in petrolatum was applied to the test animals for 48 h using a double Webril patch.

Control animals received intradermal injections of 50% FCA in distilled water, undiluted saline or 50% saline in FCA followed by dermal application of 0.8 mL of petrolatum.

On day 19 or 21, a challenge concentration of 1%, 3% or 10% of benzyl acetate in petrolatum was applied for 24 h. The control group received 10% benzyl acetate in petrolatum. The application sites were evaluated at 24 and 48 h after patch removal.

There was no incidence of sensitization at any concentration of benzyl acetate. Thus on the basis of negative skin reaction it can be concluded that thebenzyl acetateis not a skin sensitizer.