Registration Dossier
Registration Dossier
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EC number: 204-582-9 | CAS number: 122-91-8
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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs:Anisyl Formate
- Author:
- D.L.J. Opdyke
- Year:
- 1 976
- Bibliographic source:
- Food and Cosmetics toxicology, volume 14, supplement 1976, page 685
- Reference Type:
- publication
- Title:
- A toxicological and dermatological assessment of aryl alkyl alcohol simple acid ester derivatives when used as fragrance ingredients
- Author:
- D. Belsito , D. Bickers , M. Bruze , P. Calow , M.L. Dagli , A.D. Fryer ,H. Greim , Y. Miyachi , J.H. Saurat , I.G. Sipes
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology, 50 (2012) S269–S313
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Human Maximization test was conducted for test chemical Anisyl Formate (CAS No: 122-91-8) on 22 volunteers in order to determine the skin sensitization potential caused by the chemical.
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Anisyl formate
- EC Number:
- 204-582-9
- EC Name:
- Anisyl formate
- Cas Number:
- 122-91-8
- Molecular formula:
- C9H10O3
- IUPAC Name:
- (4-methoxyphenyl)methyl formate
- Test material form:
- liquid
- Details on test material:
- - Name of test material: (4-methoxyphenyl)methyl formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mol
- Smiles notation: c1(ccc(OC)cc1)COC=O
- InChl: 1S/C9H10O3/c1-11-9-4-2-8(3-5-9)6-12-7-10/h2-5,7H,6H2,1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: (4-methoxyphenyl)methyl formate/ Anisyl Formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mol
- Smiles notation: c1(ccc(OC)cc1)COC=O
- InChl: 1S/C9H10O3/c1-11-9-4-2-8(3-5-9)6-12-7-10/h2-5,7H,6H2,1H3
- Substance type: Organic
- Physical state: Liquid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- male
- 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:
- 4%
- Adequacy of induction:
- not specified
Challenge
- Route:
- other: No data available
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 22 human volunteers.
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Clinical observations:
- None of the treated volunteers had any skin sensitizing reaction.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- None of the treated volunteers had any skin sensitizing reaction.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing on the skin of 22 volunteers in a Human Maximization test
- Executive summary:
Human Maximization test was conducted for test chemical Anisyl Formate (CAS No: 122-91-8) on 22 volunteers in order to determine the skin sensitization potential caused by the chemical.
Anisyl formate was applied at concentration of 4% in petrolatum on skin of each subject and later observed for skin reactions.
None of the subjects showed any cutaneous reaction. Therefore, Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing on the skin of 22 volunteers.
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