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EC number: 268-638-4 | CAS number: 68132-46-7
- 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:
- 29 September 1983 to 13 October 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read-across is considered to be suitable based on the structural similarities between the read across substance and the test substance
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil
- EC Number:
- 263-107-3
- EC Name:
- Fatty acids, tall-oil
- Cas Number:
- 61790-12-3
- IUPAC Name:
- fatty acids, tall-oil
- Test material form:
- liquid
- Details on test material:
- - Appearance: yellow liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 180 to 280 g (after fasting)
- Fasting period before study: 18 hours
- Housing: Rats housed in groups, according to sex, or individually in stainless steel 0.5 inch, wire mesh cages. Waste material was removed daily. Cages and feeders were sanitised every two weeks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 g/kg
- The test material was dosed as supplied
- Rationale for the selection of the starting dose: based on the request of the sponsor - Doses:
- 10 g/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- The animals were observed immediately, and at 1 and 4 hours after dosing and daily thereafter for pharmacotoxic, CNS effects and mortality.
- Body weights were recorded initially and at the time of death.
- Necropsy of survivors performed: yes, the surviving animals were sacrificed on Day 14 by CO2 inhalation and a gross necropsy was performed. - Statistics:
- No statistical analysis was perfomed
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- Signs observed included piloerection and abnormal stance.
- Body weight:
- Body weights increased during the study. Initial bodyweights for males were 221.2 g and for females were 207 g and the final body weights for males were 343.4 g and for females were 260.6 g.
- Gross pathology:
- No test material related lesions were observed in any animal upon terminal necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg.
- Executive summary:
The acute oral toxicity of the test material to rats was investigated under GLP conditions.
The test material was administered at 10 g/kg by gavage to one group of ten rats (5 per sex) which were fasted for 18 hours prior to dosing. The rats were observed immediately, and at 1 and 4 hours after dosing and daily thereafter for clinical signs and mortality. Body weights were recorded initially and at the time of death. The surviving rats were sacrificed 14 days after dosing by CO2 inhalation and subjected to a gross necropsy.
No mortality was observed at a dose of 10 g/kg. There were no significant clinical signs seen at this dose level. All animals gained weight and no visible lesions were observed in the surviving animals upon terminal necropsy.
Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg.
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