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EC number: 632-619-2 | CAS number: 881685-58-1
- 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:
- 21 Jan 2014 to 06 Feb 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 632-619-2
- EC Number:
- 632-619-2
- Cas Number:
- 881685-58-1
- Molecular formula:
- C20 H23 F2 N3 O
- IUPAC Name:
- 632-619-2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan:(WIST) (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult rats
- Weight at study initiation: Between 208 g and 253 g
- Housing: Individual caging
- Diet: Autoclavable complete diet for rats and mice – breeding and maintenance. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: 6 and 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.9 – 22.8 °C
- Humidity : 27 – 55 %
- Air changes: 15-20 air exchanges per hour
- Photoperiod: 12/12 hours light/dark
IN-LIFE DATES: From: 21 Jan 2014 To: 06 Feb 2014
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- Pre-treatment: Approximately 24 hours before treatment an area on the back of the rat was shaven with an electric clipper.
- % coverage: Approximately 10 % area of the total body surface
- Type of wrap if used: Sterile gauze pads, a patch with adhesive hypoallergenic plaster and semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing: After 24 hours, the dressing was removed and the treated area was washed using body temperature water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration: 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- 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: Clinical observations along with a check of viability and mortality were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes. All animals were subjected to gross macroscopic examination. All animals were anaesthetised and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. Any gross macroscopic findings were recorded. - Statistics:
- - From the body weights, the group means and their standard deviations were calculated.
Results and discussion
Effect levels
- 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:
- There were no deaths during the study.
- Clinical signs:
- other: There were no adverse clinical signs noted in any animals throughout the study.
- Gross pathology:
- There was no evidence of macroscopic observations in animals terminated on day 14.
- Other findings:
- No treatment related skin irritation was observed in any animal throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median LD50 of the test material after a single dermal administration was > 2000 mg/kg bw in male and female RccHan:(WIST) rats.
- Executive summary:
Ten (5 male and 5 female) RccHan:(WIST) rats were treated with a single semi-occlusive dermal application of test material at the limit dose of 2000 mg/kg bw in a study according to OECD TG 402 and GLP principles. Sufficient water was used to dampen the test material to ensure good contact with the skin. The application period was 24 hours, followed by a 14-day observation period. Clinical observations along with a check of viability and mortality were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. All animals were examined macroscopically at the end of the study.
No mortality occurred during the study. No adverse clinical signs were observed after treatment with the test material or during the 14 day observation period and no effects were observed at the site of application. There were no treatment related effects on body weight or body weight gain during the observation period. There was no evidence of necropsy.
The median LD50 of test material after a single dermal administration was > 2000 mg/kg bw in male and female RccHan:(WIST) rats.
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