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EC number: 950-969-7 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt Baden - Württemberg, 12.11.2019
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Santalene oil: fermentation products of glucose with santalene synthase modified Rhodobacter sphaeroides, distilled
- EC Number:
- 950-969-7
- Molecular formula:
- not applicable
- IUPAC Name:
- Santalene oil: fermentation products of glucose with santalene synthase modified Rhodobacter sphaeroides, distilled
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Rat / Wistar / Crl:WI (Han) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 10-11 weeks
- Weight at study initiation: Animals of comparable weight, mean weight of approx. 184 g (SD 1.53)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration.
- Housing: Single housing, Makrolon cage, type III;
- Enrichment: Wooden gnawing blocks (Type NGM E-022);
- Diet: LASQCdiet® Rod16, HiHyg, LASvendi (Altromin, 32791 Lage, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known: SPF
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C +- 3°C
- Humidity: 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: april 20, 2020- may 13, 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.21 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6/f/dose
- Control animals:
- other: not applicable
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
- Clinical signs: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
No histological examinations were performed. - Statistics:
- Not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in both test groups.
- Clinical signs:
- other: No clinical signs were observed during clinical examination.
- Gross pathology:
- There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A LD50 > 2000 mg/kg bw was determined in an oral gavage study for female rats.
- Executive summary:
An acute oral toxicity study was conducted according to OECD TG 423 (GLP-compliant) with female Wistar rats. A single dose of 2000 mg/kg bw of the undiluted test item was administered by gavage to two test groups of three rats each (6 females). No mortality or clinical signs occured at the end of the observation period of 14 days. All animals gained weight in a normal range throughout the study period and there were no macroscopic pathological findings in any animal sacrificed at the end of the observation period. Under the conditions of this study, the median lethal dose of the test item after oral administration was assessed to be greater than 2000 mg/kg bw in rats.
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