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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jan 2014 to 16 May 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- 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))
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult rats, 9 - 11 weeks old
- Weight at study initiation: 171 - 181 g
- Fasting period before study: The night before treatment
- Housing: Individual caging, cage Type II, polypropylene/polycarbonat. Lignocel Bedding for Laboratory animals was available to animals during the study.
- Diet: Autoclavable complete diet for rats and mice – breeding and maintenance. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 – 24.6
- Humidity (%): 32 – 70
- Air changes (/hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 Jan 2014 To: 18 Feb 2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Carboxymethyl cellulose in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mL/kg bw
- Amount of vehicle (if gavage): 10 mL/kg bw - 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: Animals were observed individually after dosing at 30 minutes, then 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured at the start and on day 7 and 14.
- Necropsy of survivors performed: yes. All animals were euthanised at the end of the observation period by exsanguination under pentobarbital anaesthesia. All animals were subjected to gross macroscopic evaluation. The cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets and the animals were discarded. - Statistics:
- - From the body weights, the group means and their standard deviations were calculated.
- The LD50 was calculated using the AOT425StatPgm programme (version 1.0, 2001).
Results and discussion
Effect levels
- Key result
- Sex:
- 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: Decreased activity in one animal at 1 hour after the treatment. The animal was symptom free from 2 hours after the treatment.
- Gross pathology:
- There was no evidence of macroscopic observations in animals terminated on day 14.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median LD50 of the test material was estimated to be > 2000 mg/kg bw in female rats.
- Executive summary:
Five female RccHan:(WIST) rats were given a single oral (gavage) dose of 2000 mg/kg bw of the test material formulated in 0.5% carboxymethyl cellulose in a study according to OECD TG 425 and GLP principles. Prior to dosing, the animals were fasted overnight. The animals were observed individually after dosing at 30 minutes, then 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter for any signs of systemic toxicity and their body weights were recorded. All animals were examined macroscopically at the end of the study.
No deaths occurred during the study. Decreased activity in one animal at 1 hour after the treatment was recorded. The animal was symptom free from 2 hours after the treatment. There were no treatment related body weight changes. There was no evidence of the macroscopic observations in animals terminated at day 14.
Upon an acute oral administration of the test material and a 14 day post treatment observation period, the median LD50 in female rats was found to be > 2000 mg/kg bw.
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