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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 671-384-0 | CAS number: 82019-50-9
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25th February 2020 to 26th March 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Guideline:
- other: The design of this study was based on the study objective(s) and the overall product development strategy for the test article.
- GLP compliance:
- no
- Remarks:
- This is an intermediate registration and this was the study available
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,4,6-trifluorobenzamide
- Cas Number:
- 82019-50-9
- IUPAC Name:
- 2,4,6-trifluorobenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague Dawley rats were obtained. The animals were 8 weeks old and weighed between 231 to 295 g for males and 159 to 201 g for females at the initiation of dosing. Each animal was identified using a subcutaneously implanted electronic identification chip. The animals were acclimated to their designated housing for at least 6 days before the first day of dosing.
Following randomization, animals were group housed (up to 3 animals of the same sex and same dosing group together). Prior to randomization, animals were individually housed. Polycarbonate cages containing appropriate bedding equipped with an automatic watering valve.
Environmental Conditions:
Temperature: 68°F to 79°F (20°C to 26°C)
Humidity: 30% to 70%
Light Cycle: 12 hours light and 12 hours dark (except during designated procedures)
Ventilation: 10 or more air changes per hour
Diet: Lab Diet Certified CR Rodent Diet 5CR4
Type: Pellets
Frequency/Ration: Ad libitum,
Water: Ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- On Day 0, the test article was administered orally at a dose volume of 10 mL/kg. The test article was administered using a syringe attached to a gavage cannula. Individual doses were calculated
based on the animal's fasted (Day 0) body weight. Animals were returned to ad libitum feeding after dosing. Animals were staggered with Groups 1 and 2 dosing first, followed by Group 3, and then Group 4. The first day of dosing for each group was designated as Day 0. - Doses:
- Testing was conducted at dose levels of 5, 50, 300, and 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Observations
Mortality: At least twice daily (morning and afternoon) beginning upon arrival through termination/release.
Clinical: Two times on Day 0 (post-dose) with the first observations within approximately
30 minutes after dosing and daily thereafter (Days 1 to 14).
Duration of observation period following administration: 14 days
Weighing: Day -1 (prior to fasting), Day 0 (prior to dosing), and Days 7 and 14.
Necropsy of survivors performed: no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study. All animals survived until scheduled euthanasia.
- Clinical signs:
- other: Hunched posture and thin appearance were noted in a single female administered 300 mg/kg on Day 2. These observations were not considered adverse as they did not persist, they were only noted in a single animal, and there was no dose response. Other obser
- Gross pathology:
- Not performed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Administration of LSN3459540 by oral gavage once on Day 0 was well tolerated in rats at levels of 5, 50, 300, and 2000 mg/kg/day. Under the conditions of this test, the median lethal dose of LSN3459540 is estimated to be greater than 2000 mg/kg.
- Executive summary:
The objective of this study was to assess the short-term toxicity of LSN3459540 when given as a single oral administration to rats. This study was intended to provide information on the potential health hazards of the test article with respect to oral exposure. Data from this study may serve as a basis for classification and/or labeling of the test article.
The study design was as follows:Group No No. of animals Dose Material Dose (mg/kg) Male Female 1 3 3 LSN3459540 5 2 3 3 LSN3459540 50 3 3 3 LSN3459540 300 4 3 3 LSN3459540 2000
There were no test article-related effects noted during the study.
In conclusion, administration of LSN3459540 by oral gavage once on Day 0 was well tolerated in rats at levels of 5, 50, 300, and 2000 mg/kg/day. Under the conditions of this test, the median lethal dose of LSN3459540 is estimated to be greater than 2000 mg/kg.
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.