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EC number: 310-083-8 | CAS number: 102242-52-4 The complex residue resulting from the distillation of C6-24 and C6-24 unsatd. fatty acids methyl esters which is derived from natural fats having a carbon range of C6-24. It consists predominantly of satd. and unsatd. fatty acids methyl esters having carbon numbers greater than C20, dimerization products, and wax esters and boils at > 200°C (392°F) at 10 torr.
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 12,1980 to Jun4 04,1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP and some minor details missing, but well described and compliant with official guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- IUPAC Name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
Constituent 1
- Specific details on test material used for the study:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals (Wistar. MuRa Han 67 SPF) were adapted 8 days from the arrival. Their age was for males 29-30 days, for females 23-24 days. Their weight was 129 g for males, 119 g for femails.
They were caged in groups of 2-3 for cage. Room temperature of 21+2°C. 12hours light and 12 hours night. Food and water was provided ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
250 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20+10 animals per sex per dose
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- Urine: pH, albumine, Glucose, Urobilinogen, Keton corps, density, Blood, sediments
Blood: Emoglobine, Ematocrite, Cell volume, Number of eritrocytes, Number of Leucocytes, microscopical evaluation
Biochemistry: Sodium and postassium, Glucose, Minerals, GOT, GPT - Sacrifice and pathology:
- After the testing period all animals were sacrificed and analysed for histopathology
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance showed no treatment related effect at the tested dose
- Executive summary:
Nach wiederholten oralen Gaben von 250 mg das Prüfstoffes/kg KG/Arbeitstag führt die Substanz an Ratten zu den hämatologischen,
urologischen und biochemischen Befunden, die als zufällig, interindividuell spezifsch und im Rahmenberaich dar biologischen
Streubreiten liegend, gedautet warden können. Die wiaderholte orale Applikation der obigen Dosis ist demnach als dia für Ratten nicht kumulativ schädigende tägliche Gabe einzustufen.
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