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Toxicological information

Skin sensitisation

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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:
1974
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

Constituent 1
Chemical structure
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
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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