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EC number: 840-568-4 | CAS number: 1175006-56-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 870.2500 (Acute Dermal 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
Carbon Power is an end product brand name for FBS Defense (active ingredient name: complex polymeric polyhydroxy acids). This is still CAS #1175006-56-0 (soil organic matter, alkaline extract, potassium salt).
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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: 3.000-3.450 kg ; Female: 3.250 kg
Final Body Weights: Male: 3.050-3.500 kg ; Female: 3.400 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL of undiluted test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after unwrap
- Number of animals:
- 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. Each animal was prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or defects were selected for testing. A single intact exposure site was selected as the test site while the contralateral intact site served as a control site.
On Day 0, 0.5 mL of the undiluted test substance was applied to each test site and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) which was secured on both edges with strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test substance.
Removal of the Test Substance
After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible.
Observations
The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1, 24, 48, and 72 hours after unwrap.
Irritation Scoring Method
The scoring scale used to rate dermal irritation is presented in the legend to Table 1. For each animal, all of the erythema and edema scores through 72 hours were added, and the sum was divided by 4 to obtain an individual irritation score. The primary irritation index was determined by calculating the mean of the irritation scores for all the animals and was used to obtain a rating for the test substance. A Toxicity Category was assigned according to the scale presented in the legend to Table 1. The Toxicity Category is based on the erythema/edema observations at 72 hours only or the presence of necrosis at any time during the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 4065-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, nd 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 4062-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, nd 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 4060-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, nd 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 4065-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, nd 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 4062-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, nd 72 hr
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 4060-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, nd 72 hr
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See Table 1 in the uploaded full study report. All animals had erythema and edema scores of 0 at 1, 24, 48, and 72 hours after unwrap. 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:
- Remarks:
- Category IV: non-irritating
- Conclusions:
- The primary irritation index of 0.0 out of a possible 8.0 (erythema and edema together) was obtained from the observations at 1, 24, 48, and 72 hours, and was used to give Carbon Power (i.e., FBS Defense) a descriptive rating of non-irritating. Based on the 72-hour observations only, Carbon Power is assigned to Toxicity Category IV.
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