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Diss Factsheets
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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
Repeated dose toxicity: oral
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- 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
Test material
- Details on test material:
- Batch number: FEB 279-810
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Doses / concentrations
- 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
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:
- 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.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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