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EC number: 444-090-3 | CAS number: 204848-45-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25-Oct-2002 to 13-Nov-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD test guideline 423)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adoted on 22th March 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 444-090-3
- EC Name:
- -
- Cas Number:
- 204848-45-3
- Molecular formula:
- C44 H43 N3 O4
- IUPAC Name:
- Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl;CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., Manston Road, Margate, Kent, England
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 95-123 g
- Fasting period before study: overnight prior to dosing until 4 hours after dosing
- Housing:
Rats were allocated without conscious bias to cages within the treatment groups. They were housed in groups of three rats of the same sex in metal cages with wire mesh floors
- Diet:
A standard laboratory rodent diet (Special Diet Services RMl(E) SQC expanded pellet) was provided ad libitum. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Water: drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 40-70%
- Photoperiod: 12 hours dark/ 12 hours light
IN-LIFE DATES: From: 24-Oct-2002 to: 11-Nov-2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % (w/v) aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 1% (w/v) in water at a dose volume of 10 mL/kg bodyweight - Doses:
- One single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 animals (3 males and 3 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days. The day of dosing was designated Day 1.
- Frequency of observations and weighing:
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing. The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Necropsy of survivors performed: yes. All animals were subjected to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Statistics:
- Individual weekly bodyweight changes and group mean bodyweights were calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral gavage dose to a group of six rats (three males and three females) at a dose level of 2000 mg/kg.
- Clinical signs:
- Clinical signs of reaction to treatment were confined to piloerection observed in all females on Day 2, resolving completely by Day 3. No clinical signs were observed in the males during the study.
- Body weight:
- All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No abnormalities were revealed at the macroscopic examination.
- Other findings:
- No other findings were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal oral dose of the test substance to rats was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A GLP-compliant acute oral toxicity study according to OECD TG 423 was performed to determine the acute lethal dose of the test substance after oral administration. A group of three fasted male and female rats respectively received a single oral gavage dose of the test substance, formulated in 1 % w/v aqueous methylcellulose, at a dose level of 2000 mg/kg bodyweight. All animals were killed as scheduled and examined macroscopically on Day 15, the end of the observation period. There were no deaths throughout the duration of the study. Clinical signs of reaction to treatment were confined to piloerection observed in all females on Day 2, resolving completely by Day 3. No clinical signs were observed in the males during the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were revealed at the macroscopic examination at study termination on Day 15. As result, the acute lethal oral dose of the test substance was demonstrated to be greater than 2000 mg/kg bodyweight in rats.
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