Registration Dossier
Registration Dossier
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EC number: 203-105-1 | CAS number: 103-37-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- FRAGRANCE RAW MATERIAL MONOGRAPHS
- Author:
- D.L.J. Opdyke
- Year:
- 1 974
- Bibliographic source:
- Food and Cosmetics Toxicology,1974
- Reference Type:
- publication
- Title:
- A toxicological assessment of aryl alkyl alcohol
- Author:
- Belsito et al.
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To determine the skin irritation potential of test chemical.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Benzyl butyrate
- EC Number:
- 203-105-1
- EC Name:
- Benzyl butyrate
- Cas Number:
- 103-37-7
- Molecular formula:
- C11H14O2
- IUPAC Name:
- benzyl butanoate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report):Benzyl butyrate
- Substance type: Organic
- Physical state:Liquid
-Molecular formula-C11H14O2
-Molecular weight- 178.2296 g/mol
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Sex: male
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: Petrolatum
- Controls:
- not specified
- Amount / concentration applied:
- 4%
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 48 hours
- Number of animals:
- five adult male patients
- Details on study design:
- - Area of exposure: Back of humans
- Type of wrap if used: closed occlusive patch
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no irritation seen in any subjects.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical was tested at a concentration of 4 % in petrolatum which produced no irritation in a 48-hr closed-patch test in human subjects.
- Executive summary:
Skin irritation study for test chemical was conducted on five adult male patients as in a preliminary study of a maximization test. The test chemical was applied at a 4% concentration under occlusion for 48 h to the back each patients. There was no irritation seen in any subjects. Hence the test chemical considered to be not irritating to the skin of treated subjects.
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