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EC number: 268-453-9 | CAS number: 68092-29-5
- 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:
- 17 August 2005 to 7 September 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Justification for type of information:
- Refer to RAAF document in section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Tall oil
- EC Number:
- 232-304-6
- EC Name:
- Tall oil
- Cas Number:
- 8002-26-5
- Molecular formula:
- Variable
- IUPAC Name:
- Tall Oil
- Reference substance name:
- Crude Tall Oil
- IUPAC Name:
- Crude Tall Oil
- Test material form:
- liquid: viscous
- Details on test material:
- - Appearance: dark, high viscous liquid
- Storage Conditions: room temperature <25 °C in the dark, may be used under light
- Stability under storage conditions: stable
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: CrI:CD(SD)IGS BR
- Age at study initiation: Approximately 8 weeks at the time of administration.
- Weight at study initiation: 174 to 194 g
- Fasting period before study: Yes. The feed was withdrawn the evening before the administration of the test material and was offered again about three hours post administration.
- Housing: Single caging (39 x 23 cm bottom area, 18 cm high) with wire mesh lids.
- Diet (e.g. ad libitum): feed gamma irradiated with 25 kGy ⁶⁰Co, ad libitum.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.0 °C
- Humidity (%): Average of 70.6 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
IN-LIFE DATES: From: 17 August 2005 To: 7 September 2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): The individual dose volumes were calculated using the bodyweights determined on the day of the administration.
- Justification for choice of vehicle: The test material was not soluble in water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test material was available, a starting dose of 300 mg/kg bodyweight was chosen. The solutions were freshly prepared before dosing and were administered within 20 minutes. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 female animals per step (6 animals in total per dose level)
- Control animals:
- no
- Details on study design:
- The test material was administered sequentially to groups of 3 animals per step, using a starting dose of 300 mg/kg. After the initial group of rats had been dosed, a second group of animals received the test material at a dose level of 300 mg/kg.
In the absence of any toxicological effects, the test material was administered to a third group of animals at a dose level of 2000 mg/kg. A fourth and final group of animals then received the test material at the 2000 mg/kg dose level.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed within the periods 0 to 0.5, 0.5 to 1, 1 to 2, 2 to 4 and 4 to 6 hours after administration of the test material and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Bodyweights were determined before administration, 7 days post administration and 14 days post administration. Body weight gain was calculated for each week of the study, i.e. between 0 and 7 days and between 7 and 14 days following dosing.
- Necropsy of survivors performed: yes. The animals were killed by inhalation of 80 % CO₂ + 20 % air and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- No signs of systemic toxicity were observed.
- Body weight:
- All animals showed the expected gains in bodyweight over the observation period.
- Gross pathology:
- No abnormalities 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:
- Under the conditions of this study, the acute oral LD50 was >2000 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.
- Executive summary:
The acute oral toxicity potential of the test material in female Sprague-Dawley strain rats was assessed in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris under GLP conditions.
The test material was administered by gavage as a solution in corn oil; the dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose. The animals were observed for 14 days.
There was no mortality and no clinical signs were observed. All animals showed the expected gains in bodyweight throughout the observation period.
Under the conditions of this study, the acute oral LD50 was >2000 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.
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