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EC number: 413-060-1 | CAS number: 19186-97-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V. B7
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 413-060-1
- EC Name:
- -
- Cas Number:
- 19186-97-1
- Molecular formula:
- C15 H24 O4 P Br9
- IUPAC Name:
- tris[3-bromo-2,2-bis(bromomethyl)propyl] phosphate
- Reference substance name:
- 4130601
- IUPAC Name:
- 4130601
- Details on test material:
- Identity: PB-370
Reference: #E8200-58
Description: Fine white powder
Storage: Room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 30 male and 30 female Sprague-Dawley rats were received from Charles River Labs, Portage, Michigan.
Age: 5 weeks upon receipt.
Housed individually in stainless steel cages.
Fluorescent light/dark cycle of 12 hr/12 hr
Temperature: 68-73 Deg F
RH: 26-95%
Diet: Purina Certified Rodent Chow 5002 offered ad libitum
Domestic water supply, untreated with additional HCL or chlorine was provided via an automatic watering system.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on oral exposure:
- See attached document on diet preparation and administration
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- See attached document on analytical verification of concentrations
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: once daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 4000, 8000, 20000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- Four groups of rats (5 per sex per group)
- Control animals:
- yes
- Details on study design:
- See attached document on materials and methods
- Positive control:
- Yes, See attached document on materials and methods
Examinations
- Observations and examinations performed and frequency:
- See attached document on materials and methods
- Sacrifice and pathology:
- See attached document on materials and methods
- Other examinations:
- See attached document on materials and methods
- Statistics:
- See attached document on materials and methods + illustration 1
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- not attributed to the administration of the test material (see document on results)
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- not attributed to the administration of the test material (see document on results)
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- See attached document on results
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: corresponding with an actual consumption of 1361-1959 mg/kg/day (males) and 1691-2081 mg/kg/day (females))
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study the No Observable Effect Level (NOEL) was 20000 ppm, corresponding with an actual consumption of 1361-1959 mg/kg/day (males) and 1691-2081 mg/kg/day (females))
- Executive summary:
Four groups of Charles River Sprague-Dawley CD rats (5 per sex per group) were administrated graded doses of PB-370 in the diet for 28 consecutive days. The dosage levels were 0, 4000, 8000 or 20000 ppm. Clinical signs were recorded daily. Body weights and food consumption were recorded weekly. Blood was collected prior to terminal sacrifice for hematology and clinical chemistry determinations. A complete necropsy was performed on study day 28 and selected tissues were saved, weighed and evaluated for histopathologic lesions.
There were no deaths during the study. there were no treatment related clinical signs noted in any animal. Body weights, overall body weight gains and food consumption were not statistically different among treated groups when compared to controls.
There were no haematology or clinical chemistry parameter differences that were attributed to the administration of the test material. There were no statistically significant differences in organ weights or organ:brain weight ratios when comparing treated animals to control animals. There were no compound related macroscopic or microscopic observations noted during histopathological evaluation. All changes observed were related to spontaneous disease or were an artifact. Their incidence and sevirity were typical of rats of this age and strain.
Under the conditions of the study the No Observable Effect Level (NOEL) was 20000 ppm, corresponding with an actual consumption of 1361-1959 mg/kg/day (males) and 1691-2081 mg/kg/day (females))
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