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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
publication
Title:
Fragrance material review on benzyl propionate
Author:
D. McGinty, C.S. Letizia, A.M. Api
Year:
2012
Bibliographic source:
Food and Chemical Toxicology, 50, (2012), S486–S490

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
A maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy male patients
GLP compliance:
not specified
Type of study:
other: maximization test

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl propionate
EC Number:
204-559-3
EC Name:
Benzyl propionate
Cas Number:
122-63-4
Molecular formula:
C10H12O2
IUPAC Name:
benzyl propanoate
Details on test material:
- Name of test material: benzyl propionate
- Molecular formula: C10H12O2
- Molecular weight: 164.20 g/mole
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4% = 2760 µg/cm2
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4% = 2760 µg/cm2
No. of animals per dose:
25 males
Details on study design:
Application was under occlusion to the same site on the forearms of all subjects for five alternate day, 48 h periods. The patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied to fresh sites on the back for 48 h under occlusion. The challenge site was pretreated for 1 h with 10% SLS. The challenge site was evaluated at 48 and 72 h

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
4% (2760 µg/cm2)
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No sensitization reactions on evaluation of the challenge site at 48 and 72 hrs
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4% (2760 µg/cm2) . No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: No sensitization reactions on evaluation of the challenge site at 48 and 72 hrs .

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy males. On evaluation of the challenge site at 48 and 72 hrs no sensitization reactions were observed. Thus suggesting that benzyl propionate was non sensitizing to skin in humans.
Executive summary:

Maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy males. On evaluation of the challenge site at 48 and 72 hrs no sensitization reactions were observed. Thus suggesting that benzyl propionate was non sensitizing to skin in humans.