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Diss Factsheets
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EC number: 948-019-1 | 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
Acute Toxicity: Oral
Key study:
The single-dose oral toxicity of the test substance was evaluated in Sprague-Dawley rats in a study performed to the standardised guideline OECD 401 under GLP conditions. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose level of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14).
No mortality occurred during the limit test. Clinical abnormalities noted during the study were observed in one female and consisted on incidences of decreased activity, soft stools, urine/faecal staining and rales. Body weight gain was normal for all animals during the test period. No gross internal findings were observed at necropsy on study day 14.
Under the conditions of this test, the acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat (Springborn Laboratories, Inc., 1996.
Acute Toxicity: Dermal and Inhalation
The acute dermal and inhalation toxicity studies have been 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:
- key study
- Study period:
- 11 January 1996 to 15 April 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Limit test
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Description: Dark brown very viscous liquid
- Storage: Room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl: CD(R)BR VAF/Plus(R)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult
- Weight at study initiation: approximately 200 - 300 g
- Fasting period before study: Overnight
- Housing: The animals were housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 (purina Mills, Inc.) was provided ad libitum to the animals throughout the study (except during fasting)
- Water (e.g. ad libitum): Municipal tap water following treatment by reverse osmosis was available ad mibitum throughout the study
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~22
- Humidity (%): ~55
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test material was mixed with corn oil to produce a 50% w/v concentration for dose administration.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Preliminary study:
- No mortality occurred during the limit test
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- no deaths reported at this dose level
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: One female had incidenses of decreased activity, soft stools, urine/fecal staining, and rales.
- Gross pathology:
- No gross findings
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat.
- Executive summary:
The single-dose oral toxicity of the test material was evaluated in Sprague-Dawley rats in a study performed to the standardised guideline OECD 401 under GLP conditions. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test material at a dose level of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at !he time of scheduled euthanasia (day 14).
No mortality occurred during the limit test. Clinical abnormalities noted during the study were observed in one female and consisted of incidences of decreased activity, soft stools, urine/faecal staining and rales. Body weight gain was normal for all animals during the test period. No gross internal findings were observed at necropsy on study day 14.
Under the conditions of this test, the acute oral LD50 of the test material was estimated to be greater than 2000 mg/kg in the rat.
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
Justification for classification or non-classification
The acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat.
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