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EC number: 278-051-5 | CAS number: 75005-95-7
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 February 2021 to 18 June 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- September 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl 2-([1,1'-biphenyl]-4-ylcarbonyl)benzoate
- EC Number:
- 278-051-5
- EC Name:
- 2-ethylhexyl 2-([1,1'-biphenyl]-4-ylcarbonyl)benzoate
- Cas Number:
- 75005-95-7
- Molecular formula:
- C28H30O3
- IUPAC Name:
- 2-ethylhexyl 2-{[1,1'-biphenyl]-4-carbonyl}benzoate
- Test material form:
- liquid
- Details on test material:
- Purity/Composition: 96.27%
Storage Conditions: At room temperature
Test Facility test item number: 210244/A
Test item handling: No specific handling conditions required
CAS number: 75005-95-7
EC Number: 278-051-5
Substance Name: 2-ethylhexyl 2-([1,1'-biphenyl]-4-ylcarbonyl)benzoate
Constituent 1
- Specific details on test material used for the study:
- Physical Description: Colourless to pale yellow liquid (determined by Charles River Den Bosch)
Purity/Composition: 96.27%
Storage Conditions: At room temperature
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Rationale for use of males (if applicable)
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: Males: 237 to 247 g, Females: 157 to 177 g
- Fasting period before study: not reported
- Housing: polycarbonate cages (Makrolon MIV type; height 18 cm.)
- Historical data: not reported
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water (e.g. ad libitum): Municipal tap-water was freely available to each animal via water bottles, except during designated procedures.
- Acclimation period: 5 days
- Microbiological status when known: not reported
- Method of randomisation in assigning animals to test and control groups: Animals were assigned to the study at the discretion of the coordinating biotechnician.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21 °C
- Humidity (%): 42 to 63%
- Air changes (per hr): Ten or greater air changes per hour with 100% fresh air
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: 15 February 2021 To: 17 March 2021
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- >= 2.4 - <= 2.5 µm
- Geometric standard deviation (GSD):
- >= 1.9 - <= 2.1
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The animals were placed in polycarbonate restraining tubes, which were connected to the exposure chamber.
- Exposure chamber volume: not reported
- Method of holding animals in test chamber: polycarbonate restraining tubes
- Source and rate of air (airflow): An aerosol was generated by means of a Collison nebulizer and pressurized air. The mean total airflow was 18 L/min.
- Method of conditioning air: The nebulizer was placed in a water bath (temperature approximately 65 degrees Celsius)
- System of generating particulates/aerosols: Collison nebulizer
- Method of particle size determination: The samples were collected with an 8 stage Marple personal cascade impactor containing fiber glass filters (TE-290-GF. Tisch Environmental, Cleves, Ohio, USA) and a fiber glass back-up filter (SEC-290-F1, Westech, Upper Stondon, Bedfordshire, England). Amounts of test item collected were measured gravimetrically. Subsequently the Mass Median Aerodynamic Diameter (MMAD) and the Geometric Standard Deviation (GSD) were determined based on OECD guidance document No 39.
- Treatment of exhaust air: From the exposure chamber the test atmosphere was passed through a filter before it was released to the exhaust of the fume hood.
- Temperature, humidity, pressure in air chamber: 21.1 and 22.3 °C, daily mean relative humidity of 6 and 8%, pressure not reported.
TEST ATMOSPHERE
- Brief description of analytical method and equipment used: A total of 21 representative samples were taken for determination of the actual concentration during exposure at 5 mg/L. Samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the exposure chamber. Samples were drawn through a glass fiber filter (type APFC04700, Millipore, Billerica, MA, USA). Sample volumes were measured by means of a dry gas meter (type G 1.6, Actaris Meterfabriek B.V., Dordrecht, The Netherlands).
- Samples taken from breathing zone: yes
- Time needed for equilibrium of exposure concentration before animal exposure: Due to the small volume of the exposure chamber the equilibrium time was negligible.
VEHICLE
- Composition of vehicle (if applicable): not reported
- Concentration of test material in vehicle (if applicable): 7.9 mg/L
- Justification of choice of vehicle: The inhalation route of administration was selected because this route was defined as a possible route of human exposure. Nose only exposure was used since this was the most applicable method of exposure for the test model while minimizing concurrent exposure by the oral and dermal routes. Exposure levels were selected based on the EC and UN classification guidelines.
- Lot/batch no. (if required):
- Purity: 96.27
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The particle size distribution was characterized twice during each exposure period.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMAD was 2.5 µm (gsd 2.1) and 2.4 µm (gsd 1.9).
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: The starting exposure level was selected based on the available test item data and was one expected not to cause mortality. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- The time-weighted mean actual concentration was 5.2 ± 0.1 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 7.9 mg/L.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Post exposure observations were performed at periodic intervals on the day of exposure (at least two times) and once daily thereafter. Animals were weighed individually on Day 1 (pre exposure), 2, 4 and 8 and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes
- Other examinations performed:
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 7.9 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: During exposure,decreased respiratory rate was seen for all animals.After exposure, decreased respiratory rate, hunched posture and increased activity were seen for all animals on Day 1. Three males and two females also showed partly closed eyes on Day 1.
- Body weight:
- Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study and were therefore considered not indicative of toxicity.
- Gross pathology:
- No abnormalities were found at macroscopic postmortem examination of the animals.
Any other information on results incl. tables
The time-weighted mean actual concentration was 5.2 ± 0.1 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 7.9 mg/L. This resulted in a generation efficiency (ratio of actual and nominal concentration) of 65%.
The concentration was measured at time points (n=21) that were equally distributed over the exposure period, which demonstrated that the item was sufficiently stable. The variation in concentration was caused by adjustments to the generation equipment. The generation was interrupted on one occasion to adjust the set-up as the concentration was too high. To compensate for this interruption, the generation time was elongated by 4 minutes in order to achieve an actual exposure time of 240 minutes. By calculating the time-weighted mean concentration, effects of interruptions and variations were taken into account resulting in an actual reflection of the mean exposure concentration over time.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The inhalation LC50, 4h value of C991 in Wistar Han rats was established to exceed 5 mg/L.
Based on these results the test item does not have to be classified and has no obligatory labelling requirement for acute inhalation toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). - Executive summary:
The test item was administered as an aerosol by nose only inhalation for 4 hours to one group of five male and five female Wistar Han rats at a target concentration of 5 mg/L. Mortality and clinical signs were observed daily during the observation period and body weights were determined on Days 1, 2, 4, 8 and 15. Macroscopic examination was performed after terminal sacrifice (Day 15).
The time-weighted mean actual concentration was 5.2 ± 0.1 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 7.9 mg/L. This resulted in a generation efficiency (ratio of actual and nominal concentration) of 65%.
The MMAD was 2.5 µm (gsd 2.1) and 2.4 µm (gsd 1.9).
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