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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 602-997-3 | CAS number: 124495-18-7
- 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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Acute Inhalation Toxicity Study Guidelines
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 124495-18-7
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of substance: XDE-795
- Lot number: TSN 100097
- Purity: 97.4%
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, New York
- Age at study initiation: Approximately 11 and 8 weeks old in the initial and repeat exposures, respectively
- Weight at study initiation: Males: 148.8 ± 7.2 g; Females: 113.1 ± 9.2 g
- Housing: Two per cage in stainless steel wire cages during acclimation and singly housed during 2-week post-exposure period
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.63 other: microns
- Geometric standard deviation (GSD):
- 2.32
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: ADG nose-only chamber
- Exposure chamber volume: Approximately 60 liters
- Rate of air: Airflow maintained at approximately 30 liters per minute
- Method of conditioning air: Compressed air supplied to the chamber was controlled by a system designed to maintain temperature at approximately 22°C
- System of generating particulates/aerosols: Jet Mill
- Method of particle size determination: The aerodynamic particle size was determined three times during each exposure period by drawing samples from the animal breathing zone through a six-stage Cascade Impactor
- Temperature, humidity in air chamber: 23.2 ± 0.26°C, 35.0 ± 1.9%, respectively
TEST ATMOSPHERE
- Brief description of analytical method used: The mass concentration of aerosol present in the chamber was determined gravimetrically seven times during each 4-hour exposure period by drawing samples from a vertical stainless-steel tube which projected into the animal breathing zone. Aerosol particles were collected on Teflon filters with a pore size of 0.45 microns. The time-weighted average (TWA) exposure concentration was calculated from the gravimetric measurements.
- Samples taken from breathing zone: Yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 3.38 mg/L (maximum concentration that could be achieved)
- 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: The observations included an evaluation of the fur, eyes, mucous membranes and respiration. Behavior pattern and nervous system activity were assessed by specific observation for tremors, convulsions, salivation, lacrimation and diarrhea, as well as lethargy and other signs of altered central nervous system function. An additional daily observation and routine monitoring on weekends (and holidays) were limited to husbandry procedures required to ensure the availability of food and water. All rats were weighed on test days 2, 4, 8, 11, and 15 during the two-week post-exposure period.
- Necropsy of survivors performed: Yes - Statistics:
- Means and standard deviations of animal body weights, chamber temperatures, relative humidities and airflows were calculated for descriptive purposes.
Results and discussion
- Preliminary study:
- During preliminary atmosphere generation, chamber concentrations greater than 5 mg/L were obtained. However, the MMAD of the particles at this concentration was greater than 4 microns which precluded an actual exposure to 5 mg/L. To reduce the particle size of the aerosol, the test substance was sieved through a 500 micrometer sieve, and then jet-milled in the generation apparatus. In addition, a cyclone was placed between the generation apparatus and the chamber. The feed rate of the jet-mill was reduced until a suitable MMAD (≤4 µ) was obtained. The concentration at that feed rate ranged from approximately 1-4 mg/L.
An initial exposure was conducted in which a group of rats (5/sex) was exposed to a TWA chamber concentration of 1.75 mg/L test substance. However, the MMAD of the particles in this exposure was 6.17 microns and was therefore unacceptable. The low concentration and high particle size in the initial exposure were most likely due to excessive loading of material in the cyclone and glassware leading to the chamber. This limited the ability of the cyclone to remove large particles and reduced the amount of material that could pass into the chamber.
A repeat exposure was conducted with 5 rats/sex at a lower test material feed rate. The time-weighted average chamber concentration was 3.38 mg/L. Based on three determinations, the average MMAD of the particles was 3.63 microns and the GSD was 2.32. Approximately 8% of the particles were less than 1.3 microns, and approximately 28% were less than 3 microns.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 3.38 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum achievable concentration
- Mortality:
- No animals died
- Clinical signs:
- other: Transient generalized soiling, a normal observation for a nose-only study, was noted in three female rats during and after exposure. All animals appeared normal on test day two and throughout the remainder of the two-week post-exposure period.
- Body weight:
- Mean body weights of both male and female rats were decreased slightly on the day following exposure. These weight losses were within normal ranges for non-lethal acute nose-only studies in the test facility. Both male and female rats had normal weight gains thereafter.
- Gross pathology:
- A distended ovarian bursa or distended uterus were noted during the gross pathologic examination in two female rats. These observations were not considered treatment-related. No treatment-related effects were noted in any other animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4-hr LC50 (rat): > 3.38 mg/L air (maximum achievable concentration)
- Executive summary:
This study was conducted to determine the acute inhalation toxicological properties of the test substance following OECD guideline 403 and US EPA 81-3. A group of 5 rats per sex was exposed nose-only for a single 4-hour period to aerosolized test substance. In-life observations were made, and body weights were taken during a two-week post-exposure period. All animals had a gross pathologic examination at the end of the two-week observation period.
The time-weighted average concentration of the test atmosphere was 3.38 mg/L. The mass median aerodynamic diameter of the aerosol (MMAD) was 3.63 microns with a geometric standard deviation of 2.32. This was the maximum concentration that could be achieved while maintaining a respirable atmosphere (MMAD ≤4 µ).
Transient generalized soiling, a common finding in nose-only studies, was observed in several female rats. Other than generalized soiling, all rats appeared normal throughout the two-week observation period.
Mean body weights of both male and female rats were decreased slightly on the day following exposure, however, the animals had normal weight gains thereafter. A complete gross pathologic examination of all rats revealed no treatment-related effects.
No animals died as a result of exposure to test substance, therefore, the four hour LC50 of the test substance in Fischer 344 rats were greater than 3.38 mg/L.
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.