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Diss Factsheets
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EC number: 941-981-3 | CAS number: -
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (purity: 76%)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
- EC Number:
- 941-981-3
- Molecular formula:
- not available, substance is UVCB
- IUPAC Name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, Pennsylvania, USA
- Age at study initiation: 10 - 11 weeks old
- Weight at study initiation: 325 - 341 g (males), 203 - 243 g (females)
- Housing: individually housed in suspended stainless steel caging with mesh floors
- Diet: Purina Rodent Chow #5012, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: rectangular whole body Plexiglas chamber
- Exposure chamber volume: 150 L
- Source and rate of air: air compressor (JUN-AIR), approximately 25.1 L/min filtered air
- System of generating particulates/aerosols: The test atmosphere was generated using a l/4 inch JCO atomizer, FC4 fluid cap and AC 1502 air cap (Spraying Systems Inc.). Compressed air was supplied at 30 psi. The test substance was metered to the atomisation nozzle through Size 14 Master Flex Tygon tubing, using a Master Flex Pump Model 7520-35.
- Temperature, humidity in air chamber: 19-21°C, 37-65%
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals. Samples were collected using 25 mm glass fiber filters (GF/B Whatman) in a filter holder attached by 1/4 inch tygon tubing to a Reliance Electric vacuum pump Model #G557X. Filter papers were weighed before and after collection to determine the mass collected. This value was divided by the total volume of air sampled to determine the chamber concentration. The collections were carried out for 3 minutes at airflows of 4 L/min. Sample airflows were measured using an Omega Flowmeter Model #FMA 5610.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- Particle size distribution: An eight-stage Andersen cascade impactor was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathing zone of the animals at two intervals. The filter paper collection stages were weighed before and after sampling to determine the mass collected upon each stage.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The aerodynamic mass median diameter and geometric standard deviation were determined graphically using two-cycle logarithmic probit axes. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrically
- Duration of exposure:
- 4 h
- Remarks on duration:
- (also 15 min)
- Concentrations:
- The gravimetric and nominal chamber concentrations were 2.02 and 13.37 mg/L, respectively.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality, signs of gross toxicity, and behavioral changes were observed prior to exposure, at least every 30 min during exposure, upon removal from the exposure chamber and at least once daily thereafter for 14 days.
- Necropsy of survivors performed: yes (tissues and organs of the thoracic and abdominal cavities were examined)
Results and discussion
- Preliminary study:
- Prior to initiation of the full inhalation study, pre-test trials were conducted to establish generation procedures to achieve, to the extent possible, the desired chamber concentration (2.0 mg/L) and desired particle size distribution (mass median aerodynamic diameter less than or equal to 4 μm). The exposure procedures and atomisation equipment used were based on the results of pre-test trial which provided a gravimetric concentration of 2.11 mg/L and a mass median aerodynamic diameter of 3.1 μm.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.02 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: In-chamber animal observations included ocular and nasal discharge, hunched posture and hypoactivity. Upon removal from the exposure chamber, all animals recovered from the above symptoms and appeared active and healthy for the 14-day observation period.
- Body weight:
- All animals gained weight over the 14-day observation period.
- Gross pathology:
- No gross abnormalities were noted.
Any other information on results incl. tables
Table 1: Summary of particle size distribution
Sample No. |
Time of Sample (hours) |
Collection Time (minutes) |
Mass Median Aerodynamic Diameter (µm) |
Geometric Standard Deviation |
1 |
1.5 |
2 |
3.0 |
1.87 |
2 |
3 |
2 |
3.0 |
1.78 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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