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Diss Factsheets
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EC number: 473-780-7 | 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27 April to 10 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliant; no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: Five to eight weeks
- Weight at study initiation: 138 to 178 g (males), 132 to 172 g (females)
- Fasting period before study: None
- Housing: In groups of up to four by sex in polypropylene grid-floor cages suspended over trays lined with absorbant paper
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 55±15
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: A known amount of test material was mixed with a small amount of basal laboratory diet for nineteen minutes at a constant speed, setting 1 in a Hobart QE200 mixer. This pre-mix was then added to a larger amount of basal laboratory diet and mixed for a further thirty minutes at a constant speed, setting 1 in a Hobart H800 mixer.
DIET PREPARATION
- Rate of preparation of diet (frequency): Prior to treatment and then at regular intervals during the three month study period.
- Mixing appropriate amounts with (Type of food): Rat and Mouse SQC Ground Diet No. 1 Diet, Special Diets Services
Limited, Witham, Essex, UK
- Storage temperature of food: The diet was stored at room temperature in labelled, double black plastic bags in labelled, covered plastic bins when not in use. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The standard and sample solutions were analysed by HPLC using the following conditions:
HPLC : Agilent Technologies 1050, incorporating autosampler
and workstation
Column : Microsorb-MV-100-5 C18 (150 x 4.6 mm id)
Mobile phase : acetonitrile:0.1% orthophosphoric acid (85:15 v/v)
Flow-rate : 1 ml/min
UV detector wavelength : 215 nm
Injection volume : 10 μl
Retention time : ~ 3.3 mins - Duration of treatment / exposure:
- Ninety days
- Frequency of treatment:
- Daily, seven days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 250, 5000 and 20000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 21, 424 and 1682 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Twenty
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: Based on previous toxicity work
- Rationale for animal assignment: Not applicable
- Rationale for selecting satellite groups: Not applicable
- Post-exposure recovery period in satellite groups: not applicable
- Section schedule rationale: Not applicable - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once daily
BODY WEIGHT: Yes
- Individual bodyweights were recorded on Day 1 (prior the start of treatment) and at weekly
intervals thereafter. Bodyweights were also recorded at terminal kill.
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption was recorded for each cage group at weekly intervals throughout the study.
WATER CONSUMPTION: Yes
- Time schedule for examinations: Water intake was observed daily, for each cage group, by visual inspection of the water bottles for any overt changes.
OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data
- The eyes of ten selected male and female animals from the control, low, intermediate and high dose animals were examined pre-treatment and before the end of the treatment period (during Week 12).
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Week 3, Week 7, and at the end of the study (Day 90).
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: Ten male and ten female animals from each test and control group.
- Parameters checked in table [No.15] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Week 3, Week 7, and at the end of the study (Day 90).
- Animals fasted: No
- How many animals: Ten male and ten female animals from each test and control group.
- Parameters checked in table [No.16] were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: Final week of treatment.
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked in table [No.17] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Week 12 (functional performance), prior to exposure and weekly during treatment (functional/behaverioural toxicity)
- Dose groups that were examined: All
- Battery of functions tested: sensory reactivity, grip strength, motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 18)
HISTOPATHOLOGY: Yes (see table 19) - Other examinations:
- None
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):
- 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:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- HISTOPATHOLOGY:
KIDNEY: A lower incidence of globular accumulations of eosinophilic material in the proximal tubular epithelium was encountered as a probable consequence of treatment in males at 1682 mg/kg bw/day.
SPLEEN: A greater incidence of higher grades of extramedullary haemopoiesis was observed in relation to treatment for females treated with 1682 mg/kg bw/day.
BONE MARROW: Generally lower grades of severity of adipose infiltration of the marrow were seen among females treated with 1682 mg/kg bw/day.
These changes, in the absence of any degenerative changes and associated haematological changes, are generally reversible and as such, are not considered as adverse. The absence of any haematological changes also minimises the toxicological significance of these findings.
These changes were considered not to represent an adverse health effect and as such, the ‘No Observed Adverse Effect Level’ (NOAEL) was considered as 1682 mg/kg bw/day.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 682 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse health effects
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.
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