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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:
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:
Monographs on fragrance raw materials: Benzyl formate
Author:
D.L.J. Opdyke
Year:
1973
Bibliographic source:
Food and Cosmetics Toxicology. Vol. 11, Pg. 1019, 1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of Benzyl formate in human by maximization test .
GLP compliance:
not specified
Type of study:
other: Human maximization test.
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl formate
EC Number:
203-214-4
EC Name:
Benzyl formate
Cas Number:
104-57-4
Molecular formula:
C8H8O2
IUPAC Name:
benzyl formate
Test material form:
other: Liquid
Details on test material:
Details on test material
-Name of the test material : benzyl formate
-Substance type : Organic
-Physical state : colorless liquid
- Molecular formula: C8H8O2
- Molecular weight : 136.14792 g/mol
- Smiles notation: C1=CC=C(C=C1)COC=O
- 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 formate
- Molecular formula (: C8H8O2
- Molecular weight: 136.149 g/mol
- Substance type: Organic

In vivo test system

Test animals

Species:
other: Human
Strain:
other:
Remarks:
Not applicable
Sex:
not specified
Details on test animals and environmental conditions:

No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
10%
Challenge
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
10%
No. of animals per dose:
25 human
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available
- Exposure period: No data available
- Test groups: 25
- Control group: No data available
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 10%

B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: 25
- Control group: No data available
- Site: No data available
- Concentrations: 10%
- Evaluation (hr after challenge): No data available

OTHER:
Challenge controls:
no data
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No skin sensitization reaction observed
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No indication of skin sensitization.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
A maximization test was carried out for Benzyl formate in humans .The substance Benzyl formate is considered to be not sensitizing to human.
Executive summary:

Skin sensitization potential was evaluated forBenzyl formate in human.A maximization test was carried out on 25 humans at 10%Benzyl formatein petrolatum. The substanceBenzyl formate is considered to be not sensitizing to human. Therefore Benzyl formate (104-57-4 ) was considered to be non sensitizing in human.