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EC number: 942-299-9 | 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 LD50 value of the test item was determined to be greater than 2000 mg/kg bw after single oral administration in female rats (OECD 423).
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:
- March 05, 2013 - April 02, 2013
- 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
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Gennany
- Age at study initiation: 9 weeks
- Weight at study initiation: 156 to 181 g
- Fasting period before study: Diet was withheld from about 17 hours before until up to 4 hours after treatment.
- Housing: separately in type III Makrolon cages
- Diet: ad libitum (Provimi Kliba 3433)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 °C
- Humidity (%): 43 - 61%
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous Methocel K4M (aqueous hydroxypropylcellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no.: ZE10012N02; ZDP 04/13 and 05/13
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the chemical properties of the test material mortality was not expected at the highest
starting dose of 2000 mg/kg. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily. Mortality of all rats was monitored for at least 6 hours after administration and then checked
daily. All animals were weighed before treatment ( day 1) and on days 2, 4, 6, 8, 11, 13, and 15 of the
experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Preliminary study:
- Prior to testing, an In Vitra Skin Irritation Test was performed with the test item. In this study, no irritating potential could be detected.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen in rats treated with 2000 mg/kg bw.
- Clinical signs:
- No clinical signs of toxicity were seen.
- Body weight:
- The body weight development was inconspicuous throughout the study.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, it is concluded that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats.
- Executive summary:
The test material was tested for acute toxicity in 6 female rats after single oral administration of 2000 mg/kg body weight followed by a 2-week observation period.
The study was started with 2000 mg/kg bw in 3 female rats and continued with further 3 females at 2000 mg/kg bw.
No mortality was seen in the 6 female rats treated with 2000 mg/kg bw of the test item. The body weight development was inconspicuous throughout the study. No clinical signs of toxicity were observed. The gross pathological examination revealed no organ alterations.
The LD50 value of the test item is higher than 2000 mg/kg bw after single oral administration in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and Guideline conform study
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
Acute oral toxicity
The test material was tested for acute toxicity in 6 female rats after single oral administration of 2000 mg/kg body weight followed by a 2-week observation period.
The study was started with 2000 mg/kg bw in 3 female rats and continued with further 3 females at 2000 mg/kg bw.
No mortality was seen in the 6 female rats treated with 2000 mg/kg bw of the test item. The body weight development was inconspicuous throughout the study. No clinical signs of toxicity were observed. The gross pathological examination revealed no organ alterations.
The LD50 value of the test item is higher than 2000 mg/kg bw after single oral administration in female rats.
Justification for classification or non-classification
Based on the data provided, the test item is not classified and labelled for acute oral toxicity according to Regulation EC (No) 1272/2008.
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