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Registration Dossier
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Diss Factsheets
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EC number: 461-670-1 | 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:
- 2004-2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- and B 43
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 6 weeks
- Weight at study initiation: males: 216-246 g
females: 160-190 g
- Fasting period before study: none
- Housing: individually in suspended wire-mesh cages (43 x 21.5 x 18 cm)
with metal trays, containing autoclaved sawdust (SICSA) as bedding, under the cages
- Diet (e.g. ad libitum): ad libitum, SSNIFF R/M-H pelleted maintenance diet by SSNIFF Spezialdiäten GmbH, Germany
- Water (e.g. ad libitum): ad libitum, drinking water, filtered
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 C
- Humidity (%): 50 % ± 20%
- Air changes (per hr): 12 / hour (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12 h (7:00-19:00)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: MC (methyl cellulose) 0,5 %
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
suspension of test item in the vehicle (methylcellulose 0.5 % in purified water)
dose levels: 50, 150, 300 mg / kg / day
dosage volume: 5 ml / kg / day (constant)
VEHICLE
- Justification for use and choice of vehicle (if other than water): for solubility in water
- Concentration in vehicle: 10, 30, 60 mg / ml
- Amount of vehicle (if gavage): 5 ml / kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - homogenicity and stability checked at 1 and 60 mg/ml for 9 days at +4 ºC.
-concentrations of dosage preparation checked in week 1 and 4.
- all concentrations within the theoretical range ± 10 %.
-preparations at 1 and 60 mg/ml stable and homogenous for nine days at +4 ºC - Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
dose levels: 50, 150, 300 mg / kg / day dosage volume: 5 ml / kg / day (constant)
Basis:
other: gavage
- No. of animals per sex per dose:
- dose No. of animals / sex
0 (control) 5 (+2 satellites)
50 5 (+6 satellites)
150 5 (+6 satellites)
300 5 (+6 satellites) - Control animals:
- yes, concurrent vehicle
- Positive control:
- No.
Examinations
- Observations and examinations performed and frequency:
- Mortality check (daily)
Clinical observation (daily)
FOB (end of period)
Body weight and food intake (weekly)
Hematology-clinical chemistry (end of period) - Sacrifice and pathology:
- Organ weights-macroscope and microscope examinations.
- Other examinations:
- -Monitoring of estrous cycle (end of period)
-Toxicokinetics (satellite animals): day 1 and week 4.
-Sperm count, motility, morphology. - Statistics:
- Yes (decision tree according to data set).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- 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:
- not examined
- Details on results:
- Clinical signs and mortality: No mortality. Clinical sings at 300 mg/kg including piloerection, hunched posture, thin appearance, soiled regions, cold to the touch and/or ptyalism. No salient finding at neurologic observation (FOB).
Body weight and gain: affected at 300 mg/kg.
Food consumption and compound intake: affected at 300 mg/kg.
Haematology: No salient changes.
Clinical chemistry: Slightly high colesterol (x1,3) and bilirubin (x1,7) serum concentration at 300 mg/kg.
Neurobehaviour: No abnormalities (FOB).
Organ wights: increased liver weight at 150 mg/kg (x1,2) and 300 mg/kg (x1,5).
Gross pathology: no salient findings.
Histopathology: non-neoplastic centrilobular hepatocellular hypertrophy at 150 and 300 mg/kg. No changes in vaginal cyclic
nor in sperm count and morphology.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: -centrilobular hepatocellular hypertrophy from 150 mg/kg/day -clinical signs and effects on BW, FC at 300 mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.