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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July-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 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- One minor deviation 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 attached full study report.
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Experimental Animals
Source: Nichols Rabbitry Inc.; Lumberton, TX
Date Born / Date Received: 26 Apr 2009 / 15 Jul 2009
Quarantine Period: 5 days
Quantity & Sex: 2 male and 1 female (nulliparous and non-pregnant)
Animal/Group Identification: Ear punch / Cage cards
Initial Body Weights: Male: 2.500-3.025 kg ; Female: 2.650 kg
Final Body Weights: Male: 2.525-3.075 kg ; Female: 2.675 kg
Animal Husbandry
Cage Type: suspended, wire bottom, stainless steel
House: 1 per cage
Environmental Controls: set to maintain 20 °C (+/- 3 °C), 30-70% relative humidity, 12 hour light/dark cycle, 10-12 air changes/hour. Actual temp/humidity: 18-21 °C, 70-98% relative humidity
Food: PMI Feeds Inc. Lab Rabbit Diet #5321, 8 oz. daily
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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of undiluted test substance
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (2 male, 1 female)
- Details on study design:
- Test Substance Administration
Prior to starting the study, the pH of the test substance was determined to be 7.68. Healthy albino rabbits were released from quarantine. Both eyes of each animal were carefully examined within 24 hours prior to treatment with a fluorescein sodium ophthalmic solution and cobalt-filtered light. Both eyes of each animal were again carefully examined just prior to treatment, but without the fluorescein sodium ophthalmic solution. Only those animals without eye defects or irritation were selected for testing.
On Day 0, a dose of 0.1 mL of the undiluted test substance was placed into the conjunctival sac of the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were gently held together for one second to prevent loss of material. The untreated left eye served as comparative controls.
Observations
The treated eyes of all animals were examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures, and (if needed) an additional source of white light affixed to the examination table or using a handheld flashlight. The grades of ocular reaction were recorded at 1, 24, 48, and 72 hours after treatment. The corneas of all treated eyes were examined immediately after the 24-hour observation with a fluorescein sodium ophthalmic solution. A Finoff ocular transilluminator with cobalt blue filter (Welch Allyn, Skaneateles Fall, NY) was utilized to enhance visualization of fluorescein staining. Any of the corneas which exhibited fluorescein staining at the 24-hour observation were re-examined with the fluorescein sodium ophthalmic solution at each consecutive observation until fluorescein staining of the cornea no longer occurred. All treated eyes were washed with room temperature deionized water for 1 minute immediately after recording the 24-hour observation.
Irritation Scoring Method
Individual irritation scores for each animal at each scheduled observation were determined using the grading scale given in the attached study report. An average irritation score for each scheduled observation was determined, based on the number of animals tested. A maximum average irritation score was derived from the observation yielding the highest average irritation score. The maximum average irritation score was used to rate the test substance according to the rating presented in the attached study report. Any corneal involvement or iridic irritation with a score of 1 or more is considered positive. Any conjunctival irritation (redness or chemosis) with a score of 2 or more is considered positive.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 4063-F
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 4058-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 4056-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 4063-F
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 4058-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 4056-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 4063-F
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 4058-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 4056-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 4063-F
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 4058-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 4056-M
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- No irritation observed (score 0) at 1, 24, 48, and 72 hr
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See Table 1 in the uploaded full study report. All animals have parameter scores of 0 at 1, 24, 48, and 72 hours after treatment. Substance is non-irritating, toxicity category IV.
- Other effects:
- No other observed effects.
Any other information on results incl. tables
Protocol Deviations:
1) Relative humidity was outside protocol range but did not affect study outcome
Applicant's summary and conclusion
- Interpretation of results:
- other: Category IV: non-irritating
- Conclusions:
- Based on the maximum irritation score of 0.0, the test substance Carbon Power (i.e., FBS Defense) is rated non-irritating. Since there were no positive effects during the study, the test substance is assigned to Toxicity Category IV. FBS Defense does not cause eye irritation, and these results are transferable to FBS Gold.
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