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EC number: 811-432-1 | CAS number: 78433-08-6
- 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
- Study period:
- Experimental Phase: 01 February 2018 to 13 March 2018. Report Issued: 30 Aug 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Two deviations from the study plan were not ocnsidered to have affected the purpose or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(octadecylcarbamoyl)oxy]ethyl acrylate
- EC Number:
- 811-432-1
- Cas Number:
- 78433-08-6
- Molecular formula:
- C24H45NO4
- IUPAC Name:
- 2-[(octadecylcarbamoyl)oxy]ethyl acrylate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Male and female WISTAR RccHan™ : WIST strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 to 350g
- Fasting period before study: No
- Housing: The animals were housed in groups of up to three by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes.
- Diet (e.g. ad libitum): ad libitum (except during exposure)
- Water (e.g. ad libitum): ad libitum (except during exposure)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.82 µm
- Geometric standard deviation (GSD):
- 3.29
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic System for Nose Only Exposure of Rats ((ADG Developments Ltd, Hitchin, Herts, UK)
- Exposure chamber volume: Approximately 30 litres
- Equilibration: The theoretical chamber equilibration time (T99) was 4 minutes. The test atmosphere was generated for 9 minutes prior to animal insertion to ensure test item concentration was being achieved.
- Method of holding animals in test chamber: During the exposure period, each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber ‘O’ ring.
- Source and rate of air: Compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters. The air flow rate into the chamber was 40 litres/min.
- System of generating particulates/aerosols:A dust atmosphere was produced from the test item using a SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany) located adjacent to the exposure chamber.
- Method of particle size determination: The particle size of the generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK).
- Treatment of exhaust air: The extract from the exposure chamber passed through a ‘scrubber’ trap and was connected with a high efficiency filter to a metered exhaust system.
- Temperature, humidity, pressure in air chamber: The temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd, Beds., UK) located in a vacant port in the animals’ breathing zone of the chamber and recorded every 30 minutes throughout the 4-Hour exposure period.
TEST ATMOSPHERE
- Samples taken from breathing zone: yes
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Based on preliminary study using two rats. - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 4.94 mg/L
- No. of animals per sex per dose:
- 3 male and 3 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, 1 hour after termination of exposure and subsequently once daily for 14 days. Any evidence of overt toxicity was recorded at each observation.
- Weighing: Individual body weights were recorded on arrival, prior to treatment on the day of exposure (Day 0) and on Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.94 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed on the study.
- Clinical signs:
- other: Signs of hunched posture and pilo-erection were observed following removal from the chamber. Such signs are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur was noted both during and for
- Body weight:
- All males showed body weight loss on Day 1 post-exposure and expected gains in body weight during the remainder of the recovery period. With the exception of two animals that showed body weight loss on Day 1 post-exposure and one animal that showed no gain in body weight from Days 1 to 3 post-exposure, all females showed expected gains in body weight during the recovery period
- Gross pathology:
- At necropsy macroscopic observations were seen in the lungs of all animals and consisted of: pale colour, abnormal red colour, dark patches.
Any other information on results incl. tables
Exposure Chamber Concentration
The test atmosphere was sampled nine times during the exposure period and the actual concentration of the test item calculated. The mean values obtained were as follows:
Group Number | Atmosphere Concentration | ||
Mean Achieved (mg/L) | Standard Deviation | Nominal (mg/L | |
1 | 4.94 | 0.15 | 37.99 |
The chamber flow rate was maintained at 40 L/min providing 80 air changes per hour.
Particle Size Distribution
The particle size analysis of the atmosphere drawn from the animals’ breathing zone was as follows:
Group Number | Mean Achieved Atmosphere Concentration (mg/L) | Mean Mass Median Aerodynamic Diameter µm | Inhalable Fraction (%<4 µm) | Geometric Standard Deviation |
1 | 4.94 | 3.82 | 51.6 | 3.29 |
Mortality Data
The mortality data were summarised as follows:
Group Number | Mean Achieved Atmosphere Concentration (mg/L) | Deaths | ||
Male | Female | Total | ||
1 | 4.94 | 0/3 | 0/3 | 0/6 |
There were no deaths on the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the animals died in a group of six rats exposed to mean achieved atmosphere concentration of 4.94 mg/L. It was therefore considered that the acute inhalation median lethal concentration (4 hour LC50) of the test item in the Wistar strain rat was greater than 4.94 mg/L.
- Executive summary:
Introduction
The study was performed to assess the acute inhalation toxicity of the test item. The method used was designed to be compatible with that described in the OECD Guideline for Testing of Chemicals (2009) No. 436 “Acute Inhalation Toxicity – Acute Toxic Class Method” and Method B.52. Acute Inhalation Toxicity – Acute Toxic Class Method, 2014, of Commission Regulation (EC) No. 440/2008.
Methods
A group of six Wistar (RccHan™:WIST) strain rats (three males and three females) was exposed to a dust atmosphere of the test item. The animals were exposed for 4 hours using a nose only exposure system, followed by a 14 day observation period.
Results
The mean achieved atmosphere conctration was as follows:
Group Number Atmosphere Concentration Mean Achieved (mg/L) Standard Deviation Nominal (mg/L 1 4.94 0.15 37.99 The charateristics of the achieved atmosphere were as follows:
Group Number Mean Achieved Atmosphere Concentration (mg/L) Mean Mass Median Aerodynamic Diameter µm Inhalable Fraction (%<4 µm) Geometric Standard Deviation 1 4.94 3.82 51.6 3.29 The mortality data were summarised as follows:
Group Number Mean Achieved Atmosphere Concentration (mg/L) Deaths Male Female Total 1 4.94 0/3 0/3 0/6 Clinical Observations: Common abnormalities noted during the study included decreased respiratory rate, hunched posture, pilo-erection and wet fur, there were frequent instances of red/brown staining around the snout and/or eyes. All animals appeared normal on Day 1 post-exposure.
Body Weight: All males showed body weight loss on Day 1 post-exposure and expected gains in body weight during the remainder of the recovery period. Two females showed body weight loss on Day 1 post-exposure and one female showed no gain in body weight from Days 1 to 3 post-exposure. Females showed expected gains in body weight during the remainder of the recovery period.
Necropsy: The following macroscopic abnormalities were detected at necropsy: Lungs – Pale, abnormally red, dark patches.
Conclusion
None of the animals died in a group of six rats exposed to mean achieved atmosphere concentration of 4.94 mg/L. It was therefore considered that the acute inhalation median lethal concentration (4 hour LC50) of the test item in the Wistar strain rat was greater than 4.94 mg/L.
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