Registration Dossier
Registration Dossier
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EC number: 207-924-5 | CAS number: 501-52-0
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:
- Monographs on fragrance raw materials: Benzyl formate
- Author:
- D.L.J. Opdyke
- Year:
- 1 973
- 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
- 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
Constituent 1
- 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.
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