Registration Dossier
Registration Dossier
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EC number: 284-111-1 | CAS number: 84787-70-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Santalum album, Santalaceae.
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: Summary of review article on sandalwood oil
- Adequacy of study:
- supporting study
- Study period:
- 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of sandalwood oil (Santalum album L.)
- Author:
- G.A. Burdock, I.G.Carabin
- Year:
- 2 008
- Bibliographic source:
- Food and Chemical Toxicology 46 (2008) 421-432
- Report date:
- 2007
Materials and methods
- Type of study / information:
- Review article on Safety Assessment of sandalwood oil (Santalum album L.)
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- EC Number:
- 204-102-8
- EC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- Cas Number:
- 115-71-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol
- Reference substance name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- EC Number:
- 201-027-2
- EC Name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- Cas Number:
- 77-42-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol
- Reference substance name:
- (Z)-5-[(6R)-4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl]-2-methylpent-2-en-1-ol
- Cas Number:
- 176777-61-0
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-5-[(6R)-4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl]-2-methylpent-2-en-1-ol
- Reference substance name:
- (E)-(R)-(+)-5-(2,3-dimethyltricyclo[2.2.1.0^2,6]hept-3-yl)-2-methyl-2-penten-1-ol
- Cas Number:
- 14490-17-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (E)-(R)-(+)-5-(2,3-dimethyltricyclo[2.2.1.0^2,6]hept-3-yl)-2-methyl-2-penten-1-ol
- Reference substance name:
- 2-Hepten-1-ol, 2-methyl-6-(4-methylphenyl)-, (2Z)-
- Cas Number:
- 122442-36-8
- Molecular formula:
- C15H22O
- IUPAC Name:
- 2-Hepten-1-ol, 2-methyl-6-(4-methylphenyl)-, (2Z)-
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- The review article summarizes different reports and findings, covering a variety of sandalwood oil sources with varying composition (UVCB substance).
Results and discussion
Any other information on results incl. tables
Summary and Discussion: Sandalwood is a fragrant wood from which oil is derived for use in food and cosmetics. Sandalwood oil is used in the food industry as a flavor ingredient. The oil has been recognized as GRAS for use in food by FEMA and is approved for use by the FDA and the CoE. Over 100 constituents have been identified in sandalwood oil, although the major constituent (>90%) is santalol. Sandalwood has been in use for over 4000 years and the commercial use of sandalwood oil in the United States began in the early 1800s.
Although sandalwood and its oil have been used in foods as a flavoring agent for centuries and are approved for food uses, only a few studies evaluating its toxic effects were found in the scientific literature. Sandalwood oil and its major constituent, a-santolol, has low acute oral and dermal toxicity in laboratory animals. Sandalwood oil was not mutagenic in spore Rec assay. Sandalwood oil was found to have anticarcinogenic, antiviral and bactericidal activity. Few cases of irritation or sensitization reactions to sandalwood oil in humans are reported in the literature. Consumption of sandalwood oil is 0.0074 mg/kg/day.
In summary, although the available information on toxicity of sandalwood oil is limited for evaluation of its safety, the fact that sandalwood and its oil has a long history of use without any reported adverse effects; therefore consumption of sandalwood oil as an added food ingredient is considered safe at present use levels.
Applicant's summary and conclusion
- Conclusions:
- In summary, although the available information on toxicity of sandalwood oil is limited for evaluation of its safety, the fact that sandalwood and its oil has a long history of use without any reported adverse effects; therefore consumption of sandalwood oil as an added food ingredient is considered safe at present use levels.
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