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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
Endpoint summary
Administrative data
Description of key information
28- Day Repeated-dose Oral toxicity study in rats with 14 days recovery period.
91- Day Repeated-dose Oral toxicity study in rats with 28 day Recovery period
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 358 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Two oral toxicity repeated dose studies were conducted with FR-370 to evaluate any possible adverse effect implication, following subacute and subchronic exposure to the substance.
A 28 day Repeated dose Oral toxicity study in rats with 14 days recovery period was performed with FR-370. 4 groups of rats were exposed via diet to concentrations of 0, 266, 545 or 1361 mg/kg bw/day.
Oral administration
of FR-370 to rats for 28 consecutive days produced no adverse effect up
to the highest dose tested on body weights, body weight gain and food
consumption were not. There were no deaths during the study. There were
no differences in hematology or clinicl chemistry parameters that were
attributed to administration of the test material. There were no
statistically significant differences in organ weights or organ;brain
ratios for brain, liver, kidneys, adrenal and testes, when comparing
treated animals to control animals. There were no compound- related
macroscopic or microscopic lesions noted during the histopathological
evaluation. Therefore,
under the conditions of this study, the No Observable Effect
Level was 20,000 ppm in the diet (corresponding with an actual
consumption of 1361-1959 (males) and 1691-2081 (females). The NOAEL was>1361mg/kg/day
(lowest actual consumption in the highest dose group).
In a 90 day Repeated dose Oral toxicity study in rats with 28 days recovery period with FR-370, 4 groups of rats were exposed via diet to concentrations of 0, 137, 682 or 1358 mg/kg bw/day.
Following daily
repeat dose (oral gavage) administration of FR-370 to Sprague Dawley
rats, for up to 90 consecutive days at dose levels, no treatment-related
deaths occurred. No treatment-related clinical signs were noted during
the study. Mean body weights and body weight gains were significantly
increased among males receiving 2000 ppm and greater during the study.
These increases correlate to the statistically significant increases in
food consumption which were noted among males receiving 2000 ppm and
greater, and were not considered to be a toxicological effect of
treatment. No significant differences in body weights, body weight gains
or food consumption were noted among females when compared to controls.
No treatment-related ophthalmic lesions were noted during the terminal
ophthalmic
examination. No treatment-related changes in any of the urinalyses
parameters were noted when
comparing treated groups to controls. No treatment-related changes in
any of the hematology or clinical chemistry parameters were noted when
comparing treated groups to controls.
No treatment-related findings were noted during necropsy. No
statistically significant
differences in absolute or relative organ weights were noted among males
or females.
Dietary administration of PB-370 resulted in no treatment-related
histomorphologic
tissue alterations.
Under the conditions of this study, the No Observed Adverse Effect Level
(NOAEL) was 20,000 ppm (1358 and 1685 mg/kg/day for males and females,
respectively). The actual NOAEL was>1358mg/kg/day (lowest
actual consumption in the highest dose group).
Based on the
information available it can be concluded that no effect due to
increased exposure time is expected.
Justification for classification or non-classification
The substance should not be classified based on NOAEL> 1000mg/kg/day in both 28 day and 90 day oral repeated dose toxicity studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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