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EC number: 269-128-4 | CAS number: 68187-84-8
- 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:
- 20 Sept - 18 Okt 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In complience with GLP, according to OECD guideline 420.
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Castor oil, oxidized
- EC Number:
- 269-128-4
- EC Name:
- Castor oil, oxidized
- Cas Number:
- 68187-84-8
- Molecular formula:
- Not applicable for UVCB
- IUPAC Name:
- Castor oil, oxidized
- Details on test material:
- - Name of test material (as cited in study report): Castor oil, oxidized
- Physical state: amber coloured viscous liquid
- Lot/batch No.: 12.040.018
- Storage condition of test material: at room temperature in the dark
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd.
- Age at study initiation: 8 to 12 weeks
- Fasting period before study: food removed overnight prior to dosingreturned three to four hours after dosing
- Housing: in groups up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rodent 2014C Teklad Global Certified Diet (Harlan Laboratories) ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: at least 5 days
- Other: females nulliparous and non-pregnant
- Other: bodyweight variation did not exceed appr 20% of the bodyweight of the initially dosed animal
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
- Doses:
- Single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- Total of 5 animals (females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: morbidity/mortality: twice daily, early and late, during normal working days, once dayly at weekends. Clinical observations half an hour and 1,2, and 4 hours after dosing, then daily for 14 days. Individual bodyweights recorded on day 0 (prior to dosing), day 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- not relevant
Results and discussion
- Preliminary study:
- Prior to main test, a sighting test was performed (1 female rat dosed 2000 mg/kg bw), in which no toxicity was observed.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- No signs of systemic toxicity were noted.
- Body weight:
- All animals showed expected weight gains in bodyweight over the observation period.
- Gross pathology:
- No amnomalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this study. The substance does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
- Executive summary:
An acute oral toxicity test in rats was performed according to the fixed-dose procedure (OECD 420). Following a sighting test at a dose level of 2000mg/kg bw, an additional four fasted female animals were administered a single oral dose of test item (Castor oil, oxidized), as a solution in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study and all animals were subjected to gross necropsy.
No mortality was noted and no signs of systemic toxicity. No abnormalities were noted at necropsy. The oral LD50 of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
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