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EC number: 296-618-5 | CAS number: 92875-02-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Fusanus spicatus, Santalaceae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- see Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1) B.1 bis
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
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:
- Farnesol
- EC Number:
- 225-004-1
- EC Name:
- Farnesol
- Cas Number:
- 4602-84-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- 3,7,11-trimethyldodeca-2,6,10-trien-1-ol
- Reference substance name:
- (Z,6S)-2-methyl-6-(4-methylphenyl)hept-2-en-1-ol
- Cas Number:
- 78339-53-4
- Molecular formula:
- C15H22O
- IUPAC Name:
- (Z,6S)-2-methyl-6-(4-methylphenyl)hept-2-en-1-ol
- Reference substance name:
- (2R)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Cas Number:
- 78148-59-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- (2R)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Reference substance name:
- (Z)-5-(2,6-dimethyl-6-bicyclo[3.1.1]hept-2-enyl)-2-methylpent-2-en-1-ol
- Cas Number:
- 88034-74-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-5-(2,6-dimethyl-6-bicyclo[3.1.1]hept-2-enyl)-2-methylpent-2-en-1-ol
- Reference substance name:
- 2-methyl-6-[(1S)-4-methylcyclohex-3-en-1-yl]hepta-2,6-dien-1-ol
- Cas Number:
- 10067-28-4
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-methyl-6-[(1S)-4-methylcyclohex-3-en-1-yl]hepta-2,6-dien-1-ol
- Reference substance name:
- (Z)-2-methyl-5-[(1R,2R,4S)-2-methyl-3-methylidene-2-bicyclo[2.2.1]heptanyl]pent-2-en-1-ol
- Cas Number:
- 79081-90-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-2-methyl-5-[(1R,2R,4S)-2-methyl-3-methylidene-2-bicyclo[2.2.1]heptanyl]pent-2-en-1-ol
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- AnimaIs: The experiment was performed in Wistar rats (ordered as SPF-status) of the stock Mol:WIST from M & B, Ejby, DK-4623 Lille Skensved, Denmark. On the day of treatment the rats in the main study were 6 to 7 weeks old and weighed from 144 to 154 g. An acclimatisation period of at least 5 days was allowed.
Housing: The study took place in animal room No 13 provided with filtered air at a temperature of 21 °C ±3 °C and relative humidity of 55% ±15%. The room has been designed to give 10 air changes per hour and was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 0600 h to 1800 h.
The rats were kept in transparent polycarbonate cages (macrolone type III, floor area 810 cm²) with two or three in each cage, males and females separated. The cages were cleaned and the bedding changed at least twice a week. Before the animals arrived, the animal room was cleaned and disinfected with Glu-Cid®. During the study the animal room was cleaned regularly and rinsed with water.
Bedding: Bedding was softwood sawdust ”LIGNOCEL 3-4” from Hahn & Co, D-24796 Bredenbek-Kronsburg. Regular analyses for relevant possible contaminants are performed.
Diet: A pelleted complete rodent diet ”Altromin 1314" from Chr. Petersen A/S, DK-4100 Ringsted was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
Drinking water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Remarks:
- sesame oil
- Details on oral exposure:
- Treatment procedure: The test article suspended in sesame oil was administered orally by gavage to rats that had been fasted overnight. After treatment the feed was withheld for a further 3 hours.
The study was initiated with a sighting study: One female rat was given 2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight. Signs of evident toxicity were observed in this rat.
On the basis of the results of the sighting study the main study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg Aus. sandalwood oil. S. spicatum oil/kg body weight. The dose volume administered was 10 ml/kg body weight both in the sighting and the main study. - Doses:
- 2000 mg/kg b.wt.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Clinical signs: Each rat was observed at least 1, 3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days.
Body weights (b.wt.) were recorded on days 1, 2, 3, 4, 8 and 15.
Necropsy: The rat in the pilot study and all rats in the main study were killed on day 15 by an intraperitoneal injection of 5% Mebumal®. All animals were subjected to a gross necropsy examination. - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died at the selected dose level nor did they show signs of evident toxicity during the study period.
- Clinical signs:
- other: Piloerection was seen in one animal 1 hour after treatment, in one animal 3 hours after treatment, in two animals 6 hours after treatment and in one animal on day 2 after termination of treatment. Tremor and subdued behaviour was seen in one animal 6 hour
- Gross pathology:
- The post-mortem inspection revealed hydronephrosis of the right kidney of animal No 23. No abnormalities were seen in the other animals. Hydronephrosis is an incidental finding in this strain of rats and is considered not to be related to the test article.
Any other information on results incl. tables
Table: body weight development during main study
Rat No |
Dose (mg/kg bw) |
Sex |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 8 |
Day 15 |
21 |
2000 |
Male |
154 |
174 |
185 |
191 |
223 |
277 |
22 |
2000 |
Male |
153 |
165 |
176 |
182 |
206 |
258 |
23 |
2000 |
Male |
154 |
168 |
175 |
183 |
208 |
261 |
24 |
2000 |
Male |
150 |
151 |
I64 |
171 |
199 |
256 |
25 |
2000 |
Male |
147 |
157 |
163 |
169 |
191 |
237 |
26 |
2000 |
Female |
146 |
158 |
158 |
167 |
185 |
202 |
27 |
2000 |
Female |
147 |
157 |
160 |
167 |
182 |
198 |
28 |
2000 |
Female |
144 |
155 |
164 |
168 |
182 |
203 |
29 |
2000 |
Female |
144 |
160 |
157 |
160 |
169 |
184 |
30 |
2000 |
Female |
148 |
150 |
158 |
167 |
181 |
199 |
Table: daily observations during main study
|
Rat No.(sex) |
|||||||||
|
21(m) |
22(m) |
23(m) |
24(m) |
25(m) |
26(f) |
27(f) |
28(f) |
29(f) |
30(f) |
Day 1, 1h |
N |
N |
N |
N |
N |
N |
N |
P |
N |
N |
Day 1, 3h |
N |
N |
N |
N |
N |
N |
N |
N |
P |
N |
Day 1, 6h |
N |
N |
N |
N |
ST |
P |
N |
N |
P |
N |
Day 2 |
N |
N |
N |
P |
N |
N |
N |
N |
N |
N |
Day 3 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 4 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 5 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 6 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 7 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 8 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 9 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 10 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 11 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 12 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 13 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Day 15 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Key to daily observations: A = Ataxia, B = Notes, C = Unconscious, D = Diarrhoea, E = Moribund, F = Nasal discharge, G = Lacrimation, H = Hyperventilation, K = Salivation, L = Flaccid, M = Thin, N = Normal, O = Pinched abdomen, P = Piloerection, R = Laboured respiration, S = Subdued, T = Tremor, U = Distended abdomen
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD0 (oral, rat) was found being >2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of Australian sandalwood oil, S. spicatum oil in rats was determined according to the method recommended in the OECD Guideline No 420, "Acute Oral Toxicity - Fixed Dose Method”, July 1992 and the EEC Directive published in: “Official Journal of the European communities” No: L 383A, volume 35, 29.12.1992, part B1 “Acute Toxicity (Oral) - Fixed Dose Method”.
The study was initiated with a sighting study, in which one female rat was given 2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight. Signs of evident toxicity were observed in this rat.
On the basis of the results of the sighting study the main study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight.
All animals in the main study survived the treatment and showed no signs of evident toxicity.
The rats had a normal body weight gain during the study period.
Under the experimental conditions described in this report, it was found that the dose level tested (2000 mg Aus. sandalwood oil, S. spicatum oil/kg body weight), highest required dose level, did not produce mortality. The minimal lethal dose was above 2000 mg Australian sandalwood oil, S. spicatum oil/kg body weight.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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