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EC number: 606-136-2 | CAS number: 188289-44-3
- 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
Endpoint summary
Administrative data
Description of key information
The LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rats after oral administration.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 22, 1999 - September 14, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted on March 22, 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 96/54/EEC: Commission Directive of 30. July 1996 adapting to technical progress for the twentysecond time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Official Journal No. L 248, September 30, 1996)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Chemical name: 2,3`,4`,5`-Tetrafluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-biphenyl
Appearance: white, fine crystaline powder
Batch No.: E98224548
Analytical report: Merck KGaA, Darmstadt, PP AL OF2, Dr. Götzmann
End of release: October 31, 2000
released for toxicity studies.
Storage: tightly closed, dark, at room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test material was freshly prepared prior to application. The test material was prepared with an Ultra-Turrax device. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 166 (range from 154 to 174) g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 48-81%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From: day 1 To: day 15 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Methocel K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 ml/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 (m) / 3 (f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Standard statistical methods have been applied for data processing.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All the rats survived the observation period.
- Clinical signs:
- No signs of intoxication occurred after treatment.
- Body weight:
- Body weight development of the treated rats was inconspicuous.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- For regulatory purposes, the median lethal dose (LD50), after an observation period of 15 days can be declared as > 2000 mg/kg.
- Executive summary:
This study was performed according to GLP and is fully compliant OECD TG 423. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.
Reference
Study design
The test material was tested for acute toxicity in rats after oral
administration of 2000 mg/kg body weight. The test material was prepared
with aqueous Methocel® K4M Premium solution as vehicle.This
study was performed according to the „Acute toxic class method“ (ATC).
Results
No signs of intoxication were detected after treatment and no rat died.
The gross pathological examination revealed no organ alterations.
Conclusion
The median lethal dose (LD50), after an observation period of 14 days can be declared as ATC class 0 = > 2000 mg/kg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and Guideline conform study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the data provided, the test item is not classified for acute oral toxicity according to Regulation (EC) No 1272.
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