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EC number: 485-300-3 | 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
Endpoint summary
Administrative data
Description of key information
28d-repeated dose, oral: NOAEL, oral = 150 mg/kg bw/day
90d-repeated dose, oral: waived
28d- and 90d-repeated dose, dermal: waived
28d- and 90d-repeated dose, inhalation: waived
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2008-01-07 till 2008-02-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 96/54/EG, B.7
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- rat, Hsd:Wistar rats (HsdRccHan : WIST)
Age at start of study 7-8 weeks - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration:
Gavage of a suspension, using a stomach tube - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Mean Recovery Rate of the Test Item Concentration in the Test Samples:
50 mg/5 mL: 105 % of nominal (n = 4; SD = 1 %)
150 mg/5 mL: 103 % of nominal (n = 4; SD = 3 %)
1000 mg/5 mL: 110 % of nominal (n = 4; SD = 17 %) - Duration of treatment / exposure:
- Test duration: 28 days
In total 28 applications per animal were administered. - Frequency of treatment:
- Once daily,
Dosing regime: 7 days/week - Remarks:
- Doses / Concentrations:
0, 50, 150, 1000 mg/kg bw/day
Basis:
actual ingested - No. of animals per sex per dose:
- Male: 5 animals at 50 mg/kg bw/day Male: 5 animals at 150 mg/kg bw/day Male: 5 animals at 1000 mg/kg bw/day Female: 5 animals at 50 mg/kg bw/day Female: 5 animals at 150 mg/kg bw/day Female: 5 animals at 1000 mg/kg bw/day
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The highest dose level was chosen with the aim of inducing toxic effects but not death or severe suffering. Thereafter, a descending sequence of dose levels was selected with a view to demonstrate any dosage related response and no-observed-adverse effects at the lowest dose level (NOAEL).
- Positive control:
- not applicable
- 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:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical observations:
No mortality occurred during the study period.
There were no test substance-related clinical signs in any
dose group. Daily food consumption and body weight
development of the test animals were unaffected during
treatment period.
No test substance-related effects were detected during
functional and behavioral assessments, responses to reflex
testing, and sensory reactivity assessments.
Laboratory findings:
No test substance-related differences of toxicological
significance were noted in haematology, clinical
biochemistry and urinalysis parameters when compared with
the control values.
Effects in organs:
The assessment of organ weight revealed increased absolute
and relative kidney weights (not statistically significant)
in males treated at 1000 mg/kg bw/d. Significant deviations
were observed in the liver, adrenals and brain. These
changes were either noted within the ranges of historical
control data, were only observed in one sex, or resulted
from a divergent control value. In absence of a dose
response relationship or corroborative findings in
microscopy, clinical biochemistry or other evidence of
severe organ dysfunction, these findings were considered to
be of no toxicological significance. The mean relative
testes weight was significantly increased in males at 1000
mg/kg bw/d in comparison to controls, which was found
without further corroborating findings.
No relevant changes occurred upon necropsy.
Histopathology revealed test substance-related findings in
the kidneys in males and females at 1000 mg/kg bw/d. There
was a cortical and modularly tubulopathy with casts, being
more prominent in males. The lesion was characterized by
mulitfocal areas of basophilic/regenerating tubules, dilated
tubules with minor tubuloepithelial single cell necrosis and
presence of intraluminal granular casts. In addition in
males, there was a tendency towards the occurrence of more
mononuclear cell infiltrates. - Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Conclusions:
- Considering the reported data of this toxicity study it can be stated, that the Medium Dose of 150 mg/kg BW is the no observed adverse effect dose level (NOAEL) of the test substance after a total of 28 applications by gavage in Corn oil over a period of 28 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study is GLP compliant and of high quality (Klimisch score=1)
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
During the whole life cycle of the substance and especially during its use in technical plastic articles, the oral, dermal or inhalation exposure of workers can be excluded, and there is no relevant exposure to consumers, as the substance is embedded into a polymer matrix. The information that would be obtained from a 90-day oral, or 28-day, or 90-day dermal or inhalation study is considered not to be needed, as oral, dermal, and respiratory exposure is avoided by safety measures which are already in place in case of potential dusty work places, and consumer exposure can be excluded. In view of animal welfare and to avoid unnecessary animal testing it was decided to waive such studies.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study with the longest duration (28d) and the lowest NOAEL was chosen (key study)
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Testing waived based on limited inhalation exposure (acc. annex XI.3)
Binding occupational exposure limit values for fine dust are limiting exposure by the inhalation route so that no systemic effect in kidneys can be expected. Hazard assessment beyond binding occupational exposure limit values for fine dust is scientifically not justified.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Testing waived based on limited inhalation exposure (acc. annex XI.3)
Binding occupational exposure limit values for fine dust are limiting exposure by the inhalation route so that no local effect in kidneys can be expected. Substance not irritant to skin (500 mg) nor to eye (100 mg).
Binding occupational exposure limit values for fine dust are limiting systemic exposure by the inhalation route so that no systemic effect in kidneys can be expected. Hazard assessment beyond binding occupational exposure limit values for fine dust is scientifically not justified.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Testing waived based on limited inhalation exposure (acc. annex XI.3)
Binding occupational exposure limit values for fine dust are limiting dermal exposure. Systemic effect by the dermal route are very unlikely due to limeted absoprtion. The substance is not irritant to skin (500 mg) nor to eye (100 mg).
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Testing waived based on limited inhalation exposure (acc. annex XI.3)
Binding occupational exposure limit values for fine dust are limiting dermal exposure. Local dermal effects are very unlikely because the substance is not irritant to skin (500 mg) nor to eye (100 mg).
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
Based on the available toxicological data the substance is not hazardous. The only noticeable adverse effects are histopathological changes (cortical tubulopathy and medullary tubulopathy with casts) found at very high dose of 1000 mg/kg bw/day of the oral 28-day gavage study in rats. Nephrotoxicity is probably a consequence of overload and renal tubular epithelial cast formation (evidence: OECD-SIDS_CAS 108 -78 -1), and not due to intrinsic toxicological properties of the substance. The dose level at which this oral nephrotoxic effect occurs (LOAEL=1000 mg/kg bw/day) has a very large safety margin with regard to potential (worst case) human exposure (this CSR (calculated occupational exposure) -inhalation: 0.25 mg/m3 or dermal: 0.034 mg/kg bw/day). The internal exposure via the dermal route is further limited by low dermal absorption of the solid substance.
According to the criteria listed in Annex I to CLP, the substance does not have to be classified as a dangerous substance regarding chronic toxicity/specific organ toxicity.
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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