Registration Dossier
Registration Dossier
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EC number: 202-334-4 | CAS number: 94-46-2
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 peerreviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance Raw Materials Monographs: 3-methylbutyl benzoate
- Author:
- Weir
- Year:
- 1 979
- Bibliographic source:
- A Collection of Monographs Originally Appearing in Food and Cosmetics Toxicology, 1979, Pages 78
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 3-methylbutyl benzoate in Human by Human Maximisation test.
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximisation test.
- Justification for non-LLNA method:
- Not specified.
Test material
- Reference substance name:
- Isopentyl benzoate
- EC Number:
- 202-334-4
- EC Name:
- Isopentyl benzoate
- Cas Number:
- 94-46-2
- Molecular formula:
- C12H16O2
- IUPAC Name:
- isopentyl benzoate
- Details on test material:
- SMILES:CC(C)CCOC(=O)c1ccccc1
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Isoamyl benzoate (3-methylbutyl benzoate)
- Molecular formula: C12H16O2
- Molecular weight: 192.256 g/mol
- Substance type: Organic
- Physical state: Liquid
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: Topical application
- Vehicle:
- petrolatum
- Concentration / amount:
- 6%
Challenge
- Route:
- other: Topical application
- Vehicle:
- petrolatum
- Concentration / amount:
- 6%
- No. of animals per dose:
- 25 human volunteers
- Details on study design:
- RANGE FINDING TESTS:
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: Topical
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: 6%in petrolatum
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: Topical
- Concentrations: 6%in petrolatum
- Evaluation (hr after challenge): No data available.
OTHER: - Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: challenge
- Group:
- test chemical
- Dose level:
- 6% in Petrolatum
- 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 skin sensitization reaction observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing.
- Conclusions:
- Skin sensitization potential for 3-methylbutyl benzoate (94-46-2) was observed in human. The 3-methylbutyl benzoate (94-46-2) was considered to be not sensitizing to humans by human maximization test.
- Executive summary:
Skin sensitization potential for 3-methylbutyl benzoate (94-46-2) was observed in human by human maximization test. A group of 25 human volunteers were tested by maximization test at a concentration of 6% in petrolatum. No reaction was observed .Therefore, 3-methylbutyl benzoate(94-46-2) was considered to be not sensitizing to humans.
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