Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
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 form peer- reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Fragrance material review on phenethyl salicylate
Author:
A. Lapczynski, D. McGinty, L. Jones, S. Bhatia, C.S. Letizia, A.M. Api
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S467–S471
Reference Type:
publication
Title:
A toxicologic and dermatologic assessment of salicylates when used as fragrance ingredients
Author:
D. Belsito, D. Bickers, M. Bruze, P. Calow, H. Greim,J.M. Hanifin, A.E. Rogers, J.H. Saurat, I.G. Sipes, H. Tagami
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S318–S361

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
Acute dermal toxicity study of 2-phenylethyl 2-hydroxybenzoate in rabbits
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- IUPAC name: 2-phenylethyl 2-hydroxybenzoate
- Common name: Phenethyl salicylate
- Molecular formula: C15H14O3
- Molecular weight : 242.2726 g/mol
- Smiles notation : c1ccc(cc1)CCOC(=O)c2ccccc2O
- InChl: 1S/C15H14O3/c16-14-9-5-4-8-13(14)15(17)18-11-10-12-6-2-1-3-7-12/h1-9,16H,10-11H2
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- IUPAC name: 2-phenylethyl 2-hydroxybenzoate
- Common name: Phenethyl salicylate
- Molecular formula: C15H14O3
- Molecular weight : 242.2726 g/mol
- Smiles notation : c1ccc(cc1)CCOC(=O)c2ccccc2O
- InChl: 1S/C15H14O3/c16-14-9-5-4-8-13(14)15(17)18-11-10-12-6-2-1-3-7-12/h1-9,16H,10-11H2
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Administration / exposure

Type of coverage:
other: dermal
Vehicle:
not specified
Details on dermal exposure:
not specified
Duration of exposure:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
9
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:not specified
- Necropsy of survivors performed: not specified
- Other examinations performed: Mortality and clinical signs were examined.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated rabbits at 5000 mg/kg bw
Clinical signs:
No clinical sign were observed in treated rabbits at 5000 mg/kg bw
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with 2-phenylethyl 2-hydroxybenzoate dermally.
Executive summary:

In a acute oral toxicity study, rabbits were expose with 2-phenylethyl 2-hydroxybenzoate at 5000 mg/kg bw dermally and observed for 14 days. No mortality and clinical sign was observed in treated rabbits at 5000 mg/kg bw Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with 2-phenylethyl 2-hydroxybenzoate dermally.