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EC number: 247-952-5 | CAS number: 26741-53-7
- 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
Neurotoxicity
Administrative data
- Endpoint:
- neurotoxicity: acute oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 418 (Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure)
- Version / remarks:
- adopted 1984
- Deviations:
- yes
- Remarks:
- only 4 animals used; no detailed report about pathology;
- Principles of method if other than guideline:
- Combined with acute toxicity test.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- EC Number:
- 247-952-5
- EC Name:
- 3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Cas Number:
- 26741-53-7
- Molecular formula:
- C33H50O6P2
- IUPAC Name:
- 3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Details on test material:
- - Name of test material (as cited in study report): Weston 1452
- Physical state: white solid
- Analytical purity: 99.5%
- Lot/batch No.: PP-356
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Weston 1452
- Analytical purity: 99.5%
Test animals
- Species:
- hen
- Strain:
- other: White Leghorn Pullet hens, Hyline H-36
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kerr Hatcheries, Flemington, New Jersey, USA
- Age at study initiation: 12 months, from a commercial egg producing facility
- Weight at study initiation: 1.4 to 1.9 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least two weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test material was dissolved in corn oil and administered at a volume of 10.0 mL/kg using a K-9 stomach tube, Kaslow, size 12 french (levin type) fitted to a 20cc syringe.
All the Weston 1452 hens had received the same dosage 21 days before the doses reported in this report (see aucte hen study chapter 7.2.1) - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- single treatment
- Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 800 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 700 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 4 050 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 6 080 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 4
- Control animals:
- no
Examinations
- Observations and clinical examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: All hens were examined for signs of ill-health er reaction to treatment before dosing, hourly four hours after dosing and daily thereafter.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
Body weights were recorded on Days 21 (day of dosing) 22, 25, 28, 32, 35, 39, 42 and 45 for Groups III-VI which ci-incided with days 0, 1, 4, 7, 11, 14, 18, 21 and 24 for Groups VII and VIII. - Neurobehavioural examinations performed and frequency:
- Three times per week each hen was removed from the cage, acclimated to "Astroturf" for 20 minutes and then "force-exercised". Each hen was then observed and scored for signs of neuromuscular impairment. The scoring system was as follows:
Symptom free: 0
Doubtful or minor signs (slight leg weakness): 1
Positive signs of neurological impairment (unsteady or altered gait, leg weakness): 2
Moderate neurological impairment (marked leg weakness, tendency to fall back on hocks, inability to land when dropped from approximately four feet, use of wings to maintain balance, loss of toe grip): 3
Extreme neurological impairment (hypertension of limbs, inability to walk, ataxia, prostration, morbidity): 4
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The majority of hens showed green and yellow discoloration of the feces (occasionally orange) on the day of dosing or the next day, this reflects the use of corn oil vehicle and is not considered to reflect a response to treatment.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The hens remained normal in respect of body weight throughout the observation period.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no signs of toxicity and the hens remained normal in respect of appearance, mood and locomotor function throughout the observation period.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At necropsy of hens in groups I and III, there were occasional findings of discoloration of liver (F 102 and 152), spleen (#126) and kidneys (#103); these are common pathological entities in hens of this age and are not considered to reflect any delayed or residual response to treatment.
- Histopathological findings: neoplastic:
- not examined
Any other information on results incl. tables
Hens that received TOCP showed no acute effects. Progressive leg weakness, incoordination, ataxia and paralysis commenced after 12 -14 days and culminated in sacrifice in extremis 24 or 28 days after dosing. None of the Weston 1452 or vehicle dosed hens showed any signs related to treatment and were symptom-free at all neurological examinations.
Applicant's summary and conclusion
- Conclusions:
- Hens given single oral dosages of 800-6080 g/kg did not show any evidence of acute, delayed or residual toxicity.
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