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EC number: 610-623-5 | CAS number: 511540-64-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 20, 2020 - November 10, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- October 9, 2017
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluorobenzene
- EC Number:
- 610-623-5
- Cas Number:
- 511540-64-0
- Molecular formula:
- C13 H4 Br F7 O
- IUPAC Name:
- 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluorobenzene
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: no
- Age at study initiation: 13 - 14 weeks
- Weight at study initiation: 224 - 254 g
- Fasting period before study:
- Housing: Single-housed in type III Makrolon cages with a shelter and a play tunnel on softwood bedding material overnight. Because no clinical symptoms were seen one day after treatment the rats were group-housed again in type IV Makrolon cages until end of the observation period.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.0 - 24.1°C
- Humidity (%): 42.7 - 55.3%
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10% of the total body surface area
- Type of wrap if used: Patch (polypropylene nonwoven) was fixed with a tape (Fixomull stretch)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- For solids, paste formed: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight
Results and discussion
- Preliminary study:
- Due to the chemical properties of the test item, mortality after dermal administration was not expected at the highest starting dose of 2000 mg/kg bw. Therefore, the range-finding study was started in 1 female rat with 2000 mg/kg bw.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- No organ alterations were identified.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has no acute dermal toxic potential under the conditions of the present study, and the LD50 value in rats exceeds 2000 mg/kg bw after single dermal administration.
- Executive summary:
The objective of the present study was to identify potential toxic effects of the test item after single dermal administration to rats in a stepwise procedure.
The study was started with a dose-range finding study using one femae rat treated with 2000 mg/kg bw. Due to the fact, that no mortality was seen after treatment with 2000 mg/kg bw, two further females were treated with 2000 mg/kg bw in the main study.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
No mortality occurred during the course of this study. No clinical signs of toxicity were observed. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.
The LD50 value of the test item was determined to be greater than 2000 mg/kg bw.
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