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EC number: 433-060-5 | CAS number: 290822-07-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 1998
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Expiration date of the lot/batch: None provided
- Receipt date: February 7, 2000
- Appearance: White to offwhite granules
- storage: stored at room temperature.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS Hsd: Sprague Dawley® SD® rats
- Source: Harlan Sprague Dawley, Inc.
- Age at study initiation: not mentioned
- Weight at study initiation: not mentioned
- Fasting period before study: over night
- Housing: suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): PMI Certified Rodent Meal ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 37-51
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 16.03.2000 To: 30.03.2000
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE PEG 400
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- 2000 mg/kg bw single oral dose (gavage) - Doses:
- 2000 mg/kg bw, 10 ml/kg, 200 mg/ml
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Clinical Observations
Limit test animals were observed for clinical abnormalities at approximately 1, 2, 4, 8 and 24 hours (post-dose) and daily thereafter (days 1-14). A general health/mortality check was performed twice daily (in the morning and in the afternoon).
Body Weights
Individual body weights were obtained for the limit test animals prior to fasting (day -1), prior to dosing on day 0 and on days 7 and 14.
Food Consumption
Individual food consumption was recorded for all animals on days 0, 7 and 14.
Scheduled Euthanasia
All limit test animals were euthanized by carbon dioxide inhalation at study termination (day 14) and necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained. - Statistics:
- means and standard deviations
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- other: no mortality occurred
- Mortality:
- No mortality occurred during the limit test.
- Clinical signs:
- other: The most notable clinical abnormalities observed during the study included fecal/urine stain, mucoid/soft stools, diarrhea, congested breathing and dark material around the nose/eyes.
- Gross pathology:
- No gross internal findings were observed at necropsy on study day 14.
- Other findings:
- A slight decrease in food consumption was noted from day 7-14; however, adequate food consumption was noted for all animals during the test period.
Any other information on results incl. tables
Table 2: Mean body weights
Day |
Males |
Females |
||||
Mean [g] |
SD [g] |
N |
Mean [g] |
SD [g] |
N |
|
-1 |
291 |
9.6 |
5 |
214 |
11.1 |
5 |
0 |
264 |
8.3 |
5 |
193 |
8.0 |
5 |
7 |
320 |
10.9 |
5 |
217 |
8.5 |
5 |
14 |
347 |
16.4 |
5 |
224 |
9.8 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat.
- Executive summary:
The single-dose oral toxicity was evaluated in Sprague-Dawley rats. 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 of 2000 mg/kg body weight. Following dosing, the limit test rats were observed at 1,2,4, 8 and 24 hours post-dose and daily thereafter and weighed weekly. Individual food consumption was recorded 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. The most notable clinical abnormalities observed during the study included fecal/urine stain, mucoid/soft stools, diarrhea, congested breathing and dark material around the nose/eyes. Body weight gain and adequate food consumption were noted for all animals during the test period. No gross internal findings were observed at necropsy on study day 14.
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