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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 451-540-2 | 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:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- OECD 424
- 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:
- - Age/Weight at start: 6-week old; 202-233g (males) and 159-189g (females)
- Temp.: 22+/-2°C; RH: 30-70%; light/dark cycle: 12h/12h; ventilation: 12 cycles/h
- Housing: 1/cage ; food and water ad libitum except when fasting required
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% MC (methylcellulose) in water
- Details on oral exposure:
- - gavage using plastic syringe fitted with a metal probe
- dose-volume = 5ml/kg, adjusted to the most recent body weight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Homogeneity and stability: checked at 2 and 200 mg/mL, before the study start
- Control of preparations: all concentrations including controls in weeks 1 and 4
0 (Vehicle control). - Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (vehicle controls) – 150 – 450 - 1000 mg/kg
Basis:
other: 0 (vehicle controls) – 150 – 450 - 1000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control:
- None.
Examinations
- Observations and examinations performed and frequency:
- - Mortality/morbidity, Clinical signs : daily; Detailed clinical observation : weekly
- Functional Observation Battery (FOB): Once (end of dosing period)
- Body weight/Feed Intake: weekly
- Haematology (incl. coagulation) and blood biochemistry: Once (end of dosing period) - Sacrifice and pathology:
- - Organ weights and macroscopic examination: all animals
- Microscopic examination: all tssues for control and high dose rats and any gross lesion - Statistics:
- Yes (decision tree, according to distribution of data) for: Body weight , food intake, haematology, blood biochemistry and organ weights
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
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- 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:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Observations
Clinical signs and mortality
No deaths and no clinical signs at any dose. |
Body weight and weight gain
no effects |
Food consumption and compound intake (if feeding study)
No effects at any dose |
Food efficiency
not applicable |
Water consumption and compound intake (if drinking water study)
not applicable |
Ophthalmoscopic examination
Not performed |
Haematology
No relevant effects at any dose |
Clinical chemistry
No relevant effects at any dose |
Urinalysis
Not performed |
Neurobehaviour
No CNS effects according to FOB resultsat any dose |
Organ weights
No relevant effects at any dose |
Gross pathology
No major macroscopic observationsat any dose |
Histopathology: non-neoplastic
No toxicologically relevant observations |
Histopathology: neoplastic
Not applicable |
Applicant's summary and conclusion
- Conclusions:
- No overt toxicity after 4 week of oral dosing at 1000 mg/kg/day.
NOAEL = 1000 mg/kg/day po
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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