Registration Dossier
Registration Dossier
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EC number: 204-832-7 | CAS number: 127-25-3
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 from secondary source
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs: Methyl abietate
- Author:
- D.L.J Opydke
- Year:
- 1 974
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 12, Issues 7–8, December 1974, Page 931
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To assess the sensitizing potential of Methyl abietate using the Maximization assay
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Methyl abietate
- EC Number:
- 204-832-7
- EC Name:
- Methyl abietate
- Cas Number:
- 127-25-3
- Molecular formula:
- C21H32O2
- IUPAC Name:
- methyl abietate
- Details on test material:
- - Name of the test material: Methyl abietate
- IUPAC name: methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate
- Molecular formula: C21H32O2
- Molecular weight: 316.4818 g/mol
- Substance type: Organic
- Smiles: COC(=O)[C@]1(C)CCC[C@]2(C)[C@H]3CCC(=CC3=CC[C@@H]12)C(C)C
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: Methyl abietate
- IUPAC name: methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate
- Molecular formula: C21H32O2
- Molecular weight: 316.4818 g/mol
- Substance type: Organic
- Smiles: COC(=O)[C@]1(C)CCC[C@]2(C)[C@H]3CCC(=CC3=CC[C@@H]12)C(C)C
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- 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:
- 2%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- No. of animals per dose:
- 25
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- A maximization test was carried out on 25 volunteers.Methyl abietate was tested at a 2% concentration in petrolatum and produced no sensitization reaction. Therefore Methyl abietate (127-25-3) was considered to be not sensitizing in human
- Executive summary:
A maximization test was carried out on 25 volunteers.Methyl abietate was tested at a 2% concentration in petrolatum and produced no sensitization reaction. Therefore Methyl abietate (127-25-3) was considered to be not sensitizing in human.
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