Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 443-860-6 | CAS number: 302776-68-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Product Safety Labs; 2394 US Highway 130; Dayton, NJ 08810; USA
Test material
- Reference substance name:
- -
- EC Number:
- 443-860-6
- EC Name:
- -
- Cas Number:
- 302776-68-7
- Molecular formula:
- C24 H31 N O4
- IUPAC Name:
- hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Charles River Wistar Hannover, albino (SPF).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Charles River Laboratories, Raleigh, NC on May 11, 2017.
- Age at study initiation: Young adult (9 weeks)
- Weight at study initiation: 252-267 g (males) and 190-202 g (females) at experimental start. The weight variation of animals was within 20% of the mean weight for each sex.
- Housing: group housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 42-69
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.52 µm
- Geometric standard deviation (GSD):
- 2.34
- Details on inhalation exposure:
- Nose-Only Exposure Chamber:
Animals were individually housed in polycarbonate holding tubes which seal to the chamber with an “O” ring during exposure. The base unit terminates the chamber with a 0.5-inch diameter tube for discharged air.
Air Supply:
Filtered generator air was supplied to the spray atomization nozzle by an air compressor, and measured with a Mass Flow Controller. Additional filtered mixing air from the same air compressor, measured with a Mass Flow Controller, was introduced into the chamber to help uniformly distribute the test atmosphere by creating a vortex at the chamber inlet. Chamber airflow was monitored throughout the exposure period and recorded periodically. The exposure was conducted under slight negative pressure.
Ambient Conditions:
Temperature and relative humidity values were recorded every 15 minutes for the first hour of exposure and approximately every 15 or 30 minutes thereafter.
Atmosphere Generation:
The test substance was aerosolized using a Jet-Mill. The test substance was delivered from the hopper using a variable speed motor and a 3/8-inch, closed pitch helix into the Jet-Mill. Compressed generator and mixing air were both supplied. The aerosolized dust was then fed directly into the chamber through the dust outlet assembly.
Chamber Concentration Measurements:
Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals. Samples were collected using 37 mm glass fiber filters in a filter holder attached by ¼ inch Tygon® tubing to a vacuum pump. 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. Sample airflows were measured using a Mass Flow Controller.
Particle Size Distribution:
An eight-stage 1 ACFM Andersen Ambient Particle Sizing Sampler was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathing zone of the animals at three intervals. The filter paper collection stages were weighed before and after sampling to determine the mass collected upon each stage. The mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were calculated using two-cycle logarithmic probit axes.
Exposure Period:
The animals were exposed to the targeted chamber concentration for at least 4 hours. The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium (T99). At the end of the exposure period, the generation was terminated and the chamber was operated for at least 15 minutes further with clean air to allow the test atmosphere to fully dissipate. At the end of this period the animals were removed from the exposure tubes. Prior to being returned to their cages, excess test substance was removed from the fur of each animal by rinsing with tap water and wiping with clean paper towels.
Exposure condition values:
Compressed Generator Air (Lpm): 60.0
Compressed Mixing Air (Lpm): 10.0
Total Air (Lpm)*: 70.0
Compressed Generator/Mixing Air (psi): 50/10
Time for 90% equilibration of the chamber atmosphere - T90 (min): 2.05
Time for 99% equilibration of the chamber atmosphere - T99 (min): 4.09
Exposure Chamber Temp. Range (ºC): 20-23
Exposure Chamber Relative Humidity Range (%): 60-65
Ambient Room Temp. Range (ºC): 21-22
Ambient Room Relative Humidity Range (%): 57-60
Total Time of Exposure (min): 245
Number of Air Changes Per Hour: 67
*Total air = compressed generator air + compressed mixing air - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Remarks on duration:
- Total Time of Exposure (min): 245
- Concentrations:
- 5.22 mg/L
- 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 weighing: Individual body weights of the animals were recorded prior to test substance exposure (initial) and again on Days 1, 3, 7, and 14 (terminal).
- Frequency of observations: All animals were observed for mortality during the exposure period. The animals were examined for signs of gross toxicity, and behavioral changes upon removal from the exposure tube and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
- Necropsy of survivors performed: yes
All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- Statistical analysis was limited to the calculation of the mean and standard deviation.
Results and discussion
- Preliminary study:
- Pre-Test Trials
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 (5.0 mg/L) and desired particle size distribution (mass median aerodynamic diameter between 1 and 4 μm). In these trials, the following adjustments were made in an attempt to achieve these objectives:
- Air Pressure: constant
- Compressed Generator Airflow: constant
- Compressed Mixing Airflow: constant
- Total Airflow: constant
- Motor Setting: varied
- Dust Generating System: constant
- Helix Size: constant
- Material Preparation: constant
- Vacuum Pump: constant
- Concentration Sampling Time: constant
The procedures and aerosolization equipment used in the full test were based on the results of pre-test trial number 4 which provided a gravimetric chamber concentration of 5.25 mg/L and a mass median aerodynamic diameter of 2.48 μm.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 5.22 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All animals survived exposure to the test atmosphere.
- Clinical signs:
- other: Following exposure, all rats exhibited irregular respiration. However, all animals recovered by Day 2 and appeared active and healthy for the remainder of the 14-day observation period.
- Body weight:
- All animals gained body weight during the study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the end of the 14-day observation period.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.