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.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- no
- Remarks:
- Test not conducted for regulatory purposes, published research paper.
- Test type:
- acute toxic class method
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Albino Wistar rats of either sex weighing 150 - 200 g were housed under standard conditions at 25 ±5 ºC in a well-ventilated animal house approved by Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA Nº IAEC/37/10) under 12:12 h light - dark cycle. The experimental protocol (IAEC/NCP/37/10) was approved by Institutional Animal Ethical Committee, Nargund College of Pharmacy, Bangalore
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 3 rats, sex not specified
- Control animals:
- no
- Details on study design:
- The S. album stem hydro-alcoholic Extract (SASE) at a limit dose of 5000 mg/kg was administered orally to three rats and observed for behavioural changes, any toxicity and mortality up to 48 h. The extract was prepared by dissolving the commercial extract in distilled water and the concentration was not to exceed the dose of 1 mL/100 g by weight.
- Statistics:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no mortalities in the limit test.
- Clinical signs:
- other: There were no signs of toxicity in the limit test.
- Gross pathology:
- no information about effects in the publication.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortalities or signs of toxicity have been observed in the limit test at a limit concentration of 5000 mg/kg body weight in rats.
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