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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 17,2010 to September 07,2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well described GLP compliant study conducted to recognized international test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- please see remarks below
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues
- EC Number:
- 310-083-8
- EC Name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues
- Cas Number:
- 102242-52-4
- Molecular formula:
- UVCB substance, not univocal molecular formula available
- IUPAC Name:
- UVCB substance, no IUPAC name available, alternative EC chemical name: Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- Details on test material:
- - Name of test material : Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- Physical state: black , brown liquid
- Analytical purity: NO DATA
- Lot/batch No.: 070710
- Expiration date of the lot/batch:2011-05-30
- Storage condition of test material: room temperature
- Other:
The identity, composition and other characteristics which appropriately defined the batch from which the test item for this study was drawn, were determined by the Sponsor. Stability of the test item and methods of synthesis, fabrication or derivation are documented by the Sponsor.
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:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation:7-9 weeks
- Weight at study initiation: Male 176-200 g , Female 176-192g
- Housing: The animals were housed individually in cages (dimensions 48 x 37.5 x 25 cm) with stainless steel grid tops and solid bottoms. Each cage was supplied with a water bottle and food hopper.
- Diet : Special Diets Services Limited, PO BOX 705 ; ad libitum.
- Water : ad libitum
- Acclimation period: From their arrival the animals were held as stock animals at Charles River, Edinburgh and they were acclimatised to the toxico logy accommodation for at least 2 weeks before treatment.
- Justification for selection : The rat was selected as the test model because of its ready availability and proven suitability in toxicology studies.
ENVIRONMENTAL CONDITIONS: The environment is monitored throughout the day and recordings are made every 15 min.
- Temperature (°C): 20°C
- Humidity (%): 50 to 70%.
- Air changes (per hr): 15 air changes per hour.
- Photoperiod: 12 h light/dark cycle
- Other:
Cages, cage racks and water bottles were changed weekly during the study. The floor was cleaned daily and the walls and ceiling were cleaned weekly with disinfectant solution.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: 7 cm x 8 cm
- Type of wrap if used: The test item was then covered by a gauze patch, covered with a semi-occlusive tape and secured with a strip of non-irritating
occlusive tape wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing : yes, with water.
TEST MATERIAL
- Amount(s) applied : The administered doses were calculated on the basis of the body weights of the animals on the day of dosing.
- Concentration : A dose volume of 2.2 mL/kg was used and was based on the density of the test item (0.944 g/ml).
- Justification for selection: Dermal administration was selected for this study because it is a possible route of accidental human exposure and it allows hazard classification to be evaluated. - Duration of exposure:
- single 24 h application.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Dose volume: 2.2 ml/kg
5 Male
5 Female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined for reaction to treatment 5 times on the day of dosing (Day 1) and daily thereafter until kill on Day 15.
-body weight : The body weight of each individual animal was recorded before dosing on Day 1 and on Days 8 and 15.
- Necropsy of survivors performed: yes
The necropsy consisted of an examination of the cranial, thoracic and abdominal organs and tissues in situ. Lesions were recorded in descriptive terms. Abnormal tissues were collected and preserved in 10% neutral buffered formalin. Carcasses were discarded after this procedure. - Statistics:
- No formal statistical analysis was conducted.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: based on test item gravity (0.944 g/ml)
- Mortality:
- There were no unscheduled deaths during the observation period.
- Clinical signs:
- other: Clinical signs were restricted to test item residues, which were recorded in all animals after the removal of the dressings and which persisted in 2 of the rats throughout the observation period.
- Gross pathology:
- There were no abnormal findings noted in any of the females at necropsy. Two males displayed macroscopic abnormalities. The right testis of one rat was small, dark and flaccid and this was accompanied by a darkened epididymis. A few dark foci to the right middle lobe of the lung were also recorded in this animal. A second animal displayed enlarged mandibular lymph nodes. These findings are typical of background findings recorded in rats of this strain at these laboratories.
Any other information on results incl. tables
Protocol Deviation:
The males were not assigned to the study directly they were removed from their transport box, as the protocol stated. They were, however, randomly assigned to the study from stock and so this deviation was not considered to have had any impact on the integrity or outcome of the study. The daily mean humidity in the animal room was within the range of 40 to 70% that was stated in the protocol. However, there were several days when individual values were intermittently outside the range. The minimum recorded humidity was approximately 38% and the maximum was approximately 81%. Since there was no effect on the animals’ health, these deviations were not considered to have had any impact on the integrity or outcome of the study.
Method of killing:
Animals were euthanized by exposure to a rising concentration of carbon dioxide and major blood vessels were severed to exsanguinate.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dermal dosage (LD50) for Fatty acids, C6-24 and C6-24 unsaturated, methyl esters, distillation residues in Sprague-Dawley rats was estimated to be greater than 2000 mg/kg.
- Executive summary:
This study investigated the dermal toxicity potential of the test item, Fatty acids, C6-24 and C6-24 unsaturated, methyl esters, distillation residues, after a single administration to Sprague-Dawley rats. For the purposes of this report, the test item will be referred to as the distillation residues. Five males and 5 females received the distillation residues at a dose level of 2000 mg/kg. The test item was administered, as supplied, onto the dorsal trunk and covered with an occlusive patch for 24 h. The dose volume was 2.2 mL/kg, which was calculated on the basis of the density of the test item (0.944 g/mL). Animals were observed for signs of reaction to treatment 5 times on the day of dosing and once daily from Day 2 until the end of the observation period on Day 15. Body weights were recorded weekly and all animals were subjected to a necropsy examination. There were no systemic signs noted in any animal at any observation timepoint. Clinical signs were restricted to residual test item on the animals after removal of the dressings. This was seen in all animals. Body weight gain was considered to be acceptable for rats of this age and strain. Necropsy revealed no macroscopic abnormalities that were considered to be related to treatment.
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