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Diss Factsheets
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EC number: - | 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:
- August 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Two minor deviations that did not have any negative impacts on the results were described in the full study report and given in more detail below.
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement is included in the attached full study report.
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Soil organic matter, alkaline extract, potassium salt
- EC Number:
- 840-568-4
- Cas Number:
- 1175006-56-0
- IUPAC Name:
- Soil organic matter, alkaline extract, potassium salt
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Sample ID: CP-100
0.18% complex polymeric polyhydroxy acids (based on total organic carbon content of 0.1%)
Density: 0.9968 g/mL
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Experimental Animals
Source: Texas Animal Specialties, Humble, TX
Date Born / Date Received: 2 Jun 2009 / 23 Jul 2009
Quarantine Period: 5 days
Quantity & Sex: 3 females (nulliparous and non-pregnant)
Animal/Group Identification: Ear punch / Cage cards
Day-1 Weight / Day 0 (fasted) Weight: 171-195 g / 150-172 g
Animal Husbandry
Cage Type: suspended, wire bottom, stainless steel
House: 1 per cage
Environmental Controls: set to maintain 22 °C (+/- 3 °C), 30-70% relative humidity, 12 hour light/dark cycle, 10-12 air changes/hour. Actual temp/humidity: 21-22 °C, 54-92% relative humidity
Food: PMI Feeds Inc. Formulab #5008, available ad libitum except for approximately 16 hours before dosing
Water: Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system
Animal husbandry and housing at STILLMEADOW, Inc. comply with standards outlined in the “Guide for the Care and Use of Laboratory Animals” (NRC Publ.). No contaminants were expected to have been present in the feed or water that would have interfered with or affected the results of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Test Substance Preparation and Administration
The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 5.02 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing. - Doses:
- Test Substance Preparation and Administration
The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 5.02 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing. - No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- In-Life Observations
Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on days 7 and 14.
Postmortem Observations
On Day 14 after dosing, each animal was euthanized by CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.
Results and discussion
- Preliminary study:
- Normal at each observation.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality during the study.
- Clinical signs:
- other: Clinical signs are presented in Table 2. All animals appeared normal for the duration of the study.
- Gross pathology:
- Necropsy Findings: Individual necropsy findings are presented in Table 1. The gross necropsy conducted at termination of the study revealed no observable abnormalities.
Any other information on results incl. tables
Table 1: Body weights, time of death, and gross necropsy. Dose Level: 5000 mg/kg (5.02 mL/kg)
Animal No. | Dose amt. (mL) | Date of Dosing | Body Weights (g) | Time of Death* | Gross Necropsy Findings | ||
Day 0 | Day 7 | Day 14 | |||||
31 | 0.863 | 4 Aug 09 | 172 | 178 | 213 | Day 14 | NOA |
32 | 0.752 | 6 Aug 09 | 150 | 179 | 192 | Day 14 | NOA |
33 | 0.843 | 6 Aug 09 | 168 | 185 | 198 | Day 14 | NOA |
*Day of dosing is Day 0; Day 14 is terminal sacrifice
NOA: No observable abnormalities
Protocol Deviations:
1) One animal weight under protocol range but did not affect study outcome.
2) Humidity was outside protocol range but did not affect study outcome.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The test substance, Carbon Power (i.e., FBS Defense), was evaluated for its acute oral toxicity potential when administered to albino rats. The acute oral LD50 is estimated to be greater than 5000 mg/kg in females. FBS Defense is not toxic, and these results are transferable to FBS Gold.
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