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Diss Factsheets
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EC number: 943-325-1 | 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
Endpoint summary
Administrative data
Description of key information
In an acute toxic class test female rats were exposed to 2000 mg/kg bw of the substance. No mortality, systemic clinical signs, effects on body weight and macroscopic findings were reported. Blue staining of ears, eyes, tail, feet and snout as well as of the kidney was observed. The LD50 is > 2000 mg/kg bw.
Based on this low toxicity and the very low vapour pressure of the substance (limiting possibilities of inhalation exposure) both the dermal and inhalation studies are waived.
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:
- supporting study
- Study period:
- 1987
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study on formulation, no definitive conclusion can be drawn
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. THOMAE GmbH, D-7950 BIBERACH. Germany
- Age at study initiation:
- Average weight at study initiation: 188-198 g
- Fasting period before study: 16 hours (additional fasting period 16 hours before necropsy)
- Housing: 5/Sainless steel wiremesh cage type DKIII
- Diet: KLIBA-LABORDIAET 343 ad libitum (KLINGENTALMUEHLE AG CH-4303 KAISERAUGST, SWITZERLAND)
- Water: tap water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%):30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- aqua dest.
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium
MAXIMUM DOSE VOLUME APPLIED: not indicated - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily/clinical signs several times on day 1 and daily thereafter, body weight on day 1, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopy - Statistics:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 666 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- none
- Clinical signs:
- other: none observed
- Gross pathology:
- no findings
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The LD50 of a formulation of the substance is > 5000 mg/kg bw (>1666 mg/kg bw as a.i.)
- Executive summary:
Five male and female Wistar rats received a single dose of a formulation of the substance at 5000 mg/kg bw. No effects on mortality clinical signs, body weight and macroscopy were found. The LD50 of the formulation is > 5000 mg/kg bw. Based on a.i. the LD50 is >1666 mg/kg bw. The study does not allow a definitive conclusion on the height of the LD50.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
study is waived based on the low toxicity observed in the acute oral toxicity study (LD50 > 2000 mg/kg bw)
Justification for classification or non-classification
Based on the available data the substance does not need to be classified for acute toxicity according to EC No 1272/2008 (CLP Regulation)
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.