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EC number: 439-020-3 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Principles of method if other than guideline:
- - weight of animals not mentioned
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 439-020-3
- EC Name:
- -
- Cas Number:
- 446824-06-2
- Molecular formula:
- C43H55N3O10 - C65H95N3O14
- IUPAC Name:
- 1-isoctyloxycarbonyl ethylated 2,4,6 tris (2,4- hydroxyphenyl) -1,3,5 triazine derivatives
- Details on test material:
- - Substance type: Organic
- Physical state: Viscous liquid
- Storage condition of test material: Room temperature (approx. 20°C), away from direct sunlight
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: Wist (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (e.g. ad libitum): maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. The females received from the 24-OCT-2001 until the 30-OCT-2001 batch no. 73/01, then to the end of the study batch no. 74/01. The male rats received batch no. 74/01. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Delivery of Animals 24-OCT-2001 (females), 26-OCT-2001 (males)
Acclimatization 24-OCT to 30-OCT-2001 (females), 26-OCTto 1-NOV-2001 (males)
Treatment (first dose) 31-OCT-2001 (females, 2000 mg/kg), 2-NOV-2001 (males, 2000 mg/kg)
Observation 31-OCTto14-NOV-2001 (females), 2-NOVto16-NOV-2001 (males)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial performed before experimental starting date.
- Lot/batch no. (if required): 424718/113701
DOSAGE PREPARATION (if unusual):
The preparations were made shortly before each dosing.
The test item was weighed into a tared glass beaker on a suitable precision balance and the
vehicle added (weight:volume). The mixtures were prepared using a ultra sound bath then a
magnetic stirrer.
Homogeneity of the test item in the vehicle was maintained during administration using a
magnetic stirrer. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males
3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for mortality/viability daily during acclimatization, then twice daily during days 1-15, for clinical signs daily during acclimatization and then 5 times on day 1, daily during days 2-15, body weighing days 1, 8,15
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- Slightly ruffled fur was evident in two females at 2000 mg/kg on the fist test day.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and
age. - Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) >2000 mg/kg bodyweight
- Executive summary:
One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test substance at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period. Slightly ruffled fur was evident in two females at 2000 mg/kg on the fist test day. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
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