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Diss Factsheets
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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
The test item was given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item.
Under the present test conditions, a single oral administration of 2000 mg test substance to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy
Therefore, the test substance is n o n - t o x i c if swallowed, as LD50 > 2000 mg/kg b.w., p.o.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-09-19 to 2012-10-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Rattus norvegicus CD / Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Charles River Deutschland, Sulzfeld
- Strain: Rattus norvegicus CD / Crl: CD(SD)
- approx. 8 weeks
- body weight: 167 - 177 g
- Fasting period before study: 16 hours
- Diet: ad libitum, ssniff R/M-H V 1534
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 55% +/- 15 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
- Air change: 12 to 18-fold/per hour - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose volume: 10 ml/kg b.w.
- Dose: 2000 mg/kg/bw
- Vehicle: 0.8% aqueous hydroxypropylmethylcellulose
- DOSAGE PREPARATION: test item was suspended in 0.8% aqueous hydroxypropylmethylcellulose to the appropriate concentration.
The administration volume was 10 mL/kg b.w.
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 2000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 3 female rats are treated with 2000 mg/kg b.w. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: before administration, immediatly, 5, 10, 30 and 60 min, 3, 6 and 24 h after administration and at least once daily
thereafter, until day 14
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: All survived animals were necropsied at the end of the observation period - Statistics:
- not required
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of toxicity.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no other findings
- Conclusions:
- Under the present test conditions, the test item requires no labelling, as LD50 > 2000 mg/kg b.w., p.o.
- Executive summary:
The test item was given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item
Under the present test conditions, a single oral administration of 2000 mg test substance to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy
Therefore, the test substance is n o n - t o x i c if swallowed, as LD50 > 2000 mg/kg b.w., p.o.
Reference
no other information
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of the acute oral toxicity study in rats and according to the criteria of EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test item has not to be classified.
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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