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Diss Factsheets
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EC number: 812-490-0 | CAS number: 1312943-21-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 424 (Neurotoxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Aqueous solution of methylcellulose 0.5%.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 450 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 male and 5 females per doses
- Control animals:
- yes
- Details on study design:
- The doses were chosen on the basis of the results of a preliminary oral study carried out for 7 days in rats, in which the animals were treated with doses of 150, 450 and 1000 mg / kg / day.
- Positive control:
- None reported
Examinations
- Observations and examinations performed and frequency:
- Not reported
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight slowing of body weight gain is noted in males treated at a dose of 1000 mg / kg / day.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No toxicologically significant changes were noted for any of the parameters.
Blood biochemistry : Non-dose dependent increase in sodium and chlorine in males treated with 450 and 1000 mg/kg/day. Increased potassium in females at 1000 mg/kg/d
The toxicological significance of these minor abnormalities is questionable. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No significant difference was noted between control and treated animals.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day (nominal)
- Based on:
- other: nominal
- Sex:
- male/female
- Remarks on result:
- other: original NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- other: nominal
- Sex:
- male/female
- Remarks on result:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
The substance was clinically well-tolerated at all doses tested and no significant variation / observation was noted in organ weights and macroscopic examination.
Applicant's summary and conclusion
- Conclusions:
- No treatment related findings were observed at any of the nominal concentrations tested, except for a slight slowing of body weight gain noted in males treated at a dose of 1000 mg/kg/day. A non-treatment related finding of an increase in sodium and chlorine in males treated with 450 and 1000 mg/kg/day and increased potassium in females at 1000 mg/kg/d was also noted. Therefore, the substance was clinically well-tolerated at all doses tested and no significant variations or observations were noted in organ weights or macroscopic examinations. The NOAEL and NOEL were determined to be 450 and 150 mg/kg b.w./day, respectively.
- Executive summary:
The test item was investigated for repeated dose oral toxicity to male and female Sprague Dawley rats at nominal concentrations of 150, 450 and 1000 mg/kg/b.w. day over 28 days with dosing 7 days / week. The study followed the standard guidelines OECD 424 and EU method B7. No treatment related findings were observed at any of the nominal concentrations tested, except for a slight slowing of body weight gain noted in males treated at a dose of 1000 mg/kg/day. A non-treatment related finding of an increase in sodium and chlorine in males treated with 450 and 1000 mg/kg/day and increased potassium in females at 1000 mg/kg/d was also noted. Therefore, the substance was clinically well-tolerated at all doses tested and no significant variations or observations were noted in organ weights or macroscopic examinations. The NOAEL and NOEL were determined to be 450 and 150 mg/kg b.w./day, respectively.
The study is a GLP compliant, guideline study and is suitable for assessment of this endpoint with restrictions.
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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