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Diss Factsheets
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EC number: 459-290-6 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2004 may 25th to 2004 june 16th
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the OECD Guideline 420.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- SRID No. : DEV75332
Physical State and Appearance : Solid, Tan powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test System
Female Sprague-Dawley rats (Crl:CD(SD)IGS BR) were obtained from Charles River
Laboratories, Stone Ridge (Kingston), NY. All female rats used for this study were from the
same shipment. These animals were 8 to 10 weeks of age and weighed 18 1.35 to 23 1.63 grams
on the day of dosing (Day 0). All animals were randomly assigned to dose groups, Rats were
chosen for this study because they are a common representative species for toxicity studies. The
rat is the preferred rodent species recommended for use in the Organisation for Economic
Cooperation and Development (OECD) and European Community (EC) Test Guidelines. The
protocol for this study was approved by the Institutional Animal Care and Use Committee.
Husbandry
Housing
Animals were housed in an Association for Assessment and Accreditation of Laboratory
Animal Care International-accredited vivarium in accordance with the Guide for the Care
and Use of Laboratory Animals (National Research Council, 1996). The rats were singly
housed in suspended, stainless-steel, wire mesh cages. Cages and racks were washed
once a week. Absorbent paper, used to collect excreta, was changed at least three times a
week.
Environmental Conditions
The study room was maintained at 19.8 to 23.1 °C and 42.7 to 68.3% relative humidity.
A photoperiod of 12 hours light was maintained.
Acclimation Period
The animals were isolated upon arrival and allowed to acclimate for a period of 5 days.
Animals were judged to be healthy prior to testing.
Feed
Certified Rodent Diet (PMI #5002, pelleted) was available ad libitum. Feed containers
were cleaned and refilled at least once a week. No known contaminants which would
interfere with the outcome of this study were present in the feed. Analyses of feed are
maintained on file within the testing laboratory.
Water
Water was available ad libitum through an automatic watering system. The source of the
water was the local public water system. There have been no contaminants identified in
periodic water analyses that would be expected to interfere with the conduct of the study.
Semiannual analyses of water are maintained on file within the testing laboratory.
Identification
Upon arrival, all rats were identified by uniquely-numbered metal ear tags. During
randomization, study-specific animal numbers were assigned to each animal. Cage cards
contained the study-specific animal number and the ear tag number.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- Determination of Dose Levels
In a preliminary sighting study, an initial dose of 300 mg/kg of the test substance was
administered to a single female rat. Since no abnormal clinical signs were noted for this
animal on the day of or the day following dosing, a higher dose of 2000 mg/kg was
administered to a second female rat. Based on the results of the sighting study,
2000 mg/kg was administered to an additional four female rats.
Test Substance Exposure
A single dose of the test substance was administered by gavage to animals that had been
fasted overnight.
PreDaration of Test Substance in the Vehicle
For the 2000 and 300 mg/kg dose levels, the test substance was administered as a 20 or
3% suspension in the vehicle, respectively. The vehicle was corn oil. - No. of animals per sex per dose:
- Study Type Dose Level Number Of Animal Animal Numbers
Sighting 300 mg/kg 1 Female 481
Sighting & Main 2000 mg/kg 1 Female 482
Main 2000 mg/kg 4 Females 483 - 486 - Control animals:
- no
- Details on study design:
- Clinical Observations
Animals were observed three times on the day of dosing (Day 0), and once each day
thereafter for the duration of the experiment. Observations included, but were not limited
to, examination of the hair, skin, eyes, mucous membranes, motor activity, feces, urine,
respiratory system, circulatory system, autonomic nervous system, central nervous
system, and behavior patterns.
Necropsy
All animals were euthanatized and necropsied at the completion of the 14-day
observation period.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 mg/kg bw
- Remarks on result:
- other: rat 481
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat 482
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat 483
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat 484
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat 485
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat 486
- Mortality:
- No mortality was observed during the 14-day observation period for rats administered a dose of
2000 mg/kg of the test substance.
LD50 for female rats: > 2000 mg/kg (95% C.I. = No Range Calculable) - Clinical signs:
- Summary and individual clinical signs are presented in the Appendix on pages 2 - 4. In the
preliminary sighting study, no abnormal clinical signs were noted during the observation period
for single 300 mg/kg rat or the five 2000 mg/kg rats. - Body weight:
- Mean and individual body weights and body weight gains are presented in the Appendix on
pages 5 - 6. All animals gained weight during both weeks of the study. - Other findings:
- Necropsy Findings
Summary and individual gross pathology tables are presented in the Appendix on pages 7 - 9.
No treatment-related changes were observed at necropsy, and no tissues were collected for
microscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the oral LD50 for female rats, the test substance was classified as, at most, slightly toxic
according to the criteria set forth by Hodge and Sterner (1949) and requires no toxicity
classification as defined in the 28th Adaptation of the EC Classification, Packaging and Labelling
of Dangerous Substances Directive. - Executive summary:
In a preliminary sighting study for the acute oral toxicity study, an initial dose of 300 mg/kg of the test substance was administered by gavage to a single female rat. The test substance was administered as a 3% suspension in a corn oil vehicle. Since no clinical signs or signs of toxicity were noted for this rat, a higher dose of 2000 mg/kg was administered to a second female rat. At the 2000 mg/kg dose level, the test substance was administered as a 20% suspension in the same corn oil vehicle. No abnormalities were noted for the 2000 mg/kg female used in the sighting study. Based on these results, 2000 mg/kg was selected as the main study beginning dose. For the main study, four additional female rats were administered a single dose of 2000 mg/kg of the test substance by gavage, thereby creating a group of five animals at this dose level. No abnormal clinical signs were noted for the additional four 2000 mg/kg females. No mortality was observed, and all animals gained weight. No treatment-related changes were observed at necropsy and no tissues were collected for histological examination. The acute oral LD50 for this test substance was greater than 2000 mg/kg for female rats.
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