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EC number: 640-454-2 | CAS number: 17318-08-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Remarks:
- The study was conducted to meet the national regulatory requirements in a non-EEA country.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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 402 (Acute Dermal Toxicity)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 5-bromo-1,3-dichloro-2-fluorobenzene
- EC Number:
- 640-454-2
- Cas Number:
- 17318-08-0
- Molecular formula:
- C6H2 BrCl2F
- IUPAC Name:
- 5-bromo-1,3-dichloro-2-fluorobenzene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAGE® Labs
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult (10-12 weeks)
- Weight at study initiation: males 334-376 grams and females 210-239 grams
- Fasting period before study: no
- Housing: Animals were group housed, except on the day of application, at which time they were singly housed until the animals were deemed acceptable, based on observations, to return to group housing.
- Diet (e.g. ad libitum): Envigo Teklad Global 16% Protein Rodent Diet #2016 ad libitum
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: 21 or 29 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 52-77
- Air changes (per hr): 12 or 13
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: Start: June 14, 2018; End: July 11, 2018
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Initial testing was conducted on one male and one female rat to determine extreme clinical signs or severe irritation potential of the test substance. Due to the absence of clinical signs or severe local signs of irritation, an additional four males and four females were tested. Five thousand milligrams of the test substance per kilogram of body weight was applied evenly over a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface) and covered with a 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance. The rats were then returned to their designated cages. The day of application was considered Day 0 of the study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed with a 3% soap solution followed by tap water and a paper towel to remove any residual test substance. - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw (Individual doses were calculated based on the initial body weights, taking into account the density of the test substance)
- No. of animals per sex per dose:
- Five (initial test was done with one animal per sex)
- Control animals:
- no
- Details on study design:
- The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours after application 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 behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
Individual body weights of the animals were recorded prior to test substance application (initial) and again on day 7 and day 14 (terminal).
All surviving rats were killed by CO2 inhalation at the end of the 14-day observation period.
Gross necropsies were performed on all animals killed at the end of the study. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- Statistical analysis was limited to the calculation of the mean density value for dosing. Since no deaths occurred at the limit dose, the LD50 was determined without the need of statistical analysis.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: All animals survived test substance administration during the study. Other than the dermal irritation noted at the dose site of all animals between Days 1 and 8, there were no other adverse clinical findings recorded for any animal over the course of the
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the single dose acute dermal median lethal dose (LD50) of CA5528 is greater than 5000 mg/kg of body weight in male and female rats.
- Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for CA5528 to produce toxicity from a single topical application. Initially, 5000 mg/kg of the test substance was applied to the skin of one healthy male rat and one healthy female rat for 24 hours. Due to the absence of clinical signs or severe local signs of irritation, an additional four males and four females were tested. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application (initial), on Day 7, and on Day 14 (terminal). Necropsies were performed on all animals.
All animals survived test substance administration and gained body weight during the study. Other than the dermal irritation noted at the dose site of all animals between Days 1 and 8, there were no other adverse clinical findings recorded for any animal over the course of the study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
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