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EC number: 271-402-3 | CAS number: 68554-12-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 420 and GLPs.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Resin acids and Rosin acids, hydrogenated, potassium salts
- EC Number:
- 273-572-4
- EC Name:
- Resin acids and Rosin acids, hydrogenated, potassium salts
- Cas Number:
- 68990-01-2
- IUPAC Name:
- 68990-01-2
- Details on test material:
- -Test material (as cited in report): Resin acids and Rosin acids, hydrogenated, potassium salts
-Batch/Lot number: X29363-079
-Physical state: Solid, tan chunks
-Supplier: Eastman Chemical Company, Kingsport, Tennessee, USA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Source: Charles River Laboratories, Stone Ridge (Kingston), NY
-Sex: female
-Acclimation period: 5 days
-Age at study initiation: 8-9 weeks
-Weight at study initiation: 178-190 g
-Housing: individually in suspended, stainless-steel, wire-mesh cages
-Diet: Certified Rodent Diet (PMI #5002), pellets; ad libitum
-Water: Rochester, New York public water, ad libitum
-Method of animal identification: uniquely-numbered metal ear tags
-Method of animal distribution: Animals were randomly selected and assigned to dose groups from the same shipment using a computer-generated list. After assignment, body weights were determined to ensure that individual body weights were within 20% of the mean weight.
ENVIRONMENTAL CONDITIONS:
-Temperature (°C): 21.6-24.2
-Humidity (%): 40.6-51.2
-Photoperiod: 12 hours light/12 hours dark cycle
IN-LIFE DATES:
-Experimental Start Date: 2004-11-15
-Experimental Completion Date: 2004-12-01
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test substance was administered as a 3% suspension in corn oil for the initial dose of 300 mg/kg bw and as a 20% suspension in corn oil for the 2000 mg/kg bw doses. The test substance was administered as a single dose by oral gavage to rats that had been fasted overnight. Data from a sighting study were used to establish the dose level for the main study.
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw (1 female rat) and 2000 mg/kg bw (5 female rats)
- 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 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.
Body weights:
Body weights were measured on Days 0 (prior to treatment), 7 and 14.
Necropsy:
All animals were euthanized and necropsied at the completion of the 14-day observation period. - Statistics:
- No statistical analysis was required during the study. No dose/mortality curve was constructed because of the limited number of animals and dose groups.
Results and discussion
- Preliminary study:
- In a preliminary sighting study, an initial dose of 300 mg/kg bw of the test material was administered to a single female rat. Abnormal clinical signs were limited to softened feces noted for this animal so a higher dose of 2000 mg/kg bw was administered to a second female rat. Based on an absence of clinical signs or mortality, 2000 mg/kg bw was administered to 4 additional female rats.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the 14-day observation period.
- Clinical signs:
- other: The one rat administered the dose of 300 mg/kg bw produced softened feces the day after test substance administration. No other abnormal clinical signs were noted for this animal. All animals administered the dose of 2000 mg/kg bw appeared normal througho
- Gross pathology:
- No treatment-related changes were observed at necropsy and no tissues were collected for microscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- When Resin acids and Rosin acids, hydrogenated, potassium salts was administered by gavage to female rats at a dose level of 2000 mg/kg bw, no deaths or significant systemic effects were observed. The oral LD50 value for female rats was > 2000 mg/kg bw.
Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for acute oral toxicity in Annex I of Directive 67/548/EEC. Based on the oral LD50 value of greater than 2000 mg/kg bw, Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for acute lethality by the oral route according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) defines a fifth category for acute toxicity for chemicals with oral LD50 values between 2000 and 5000 mg/kg bw. Insufficient data were available from this study to provide a definitive classification under UN GHS. Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for target organ toxicity in Annex I of Directive 67/548/EEC. Resin acids and Rosin acids, hydrogenated, potassium salts is not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for Specific Target Organ Toxicity – Single Exposure. - Executive summary:
In a fixed-dose acute oral toxicity study, 1 female rat was administered a single dose of 300 mg/kg bw of Resin acids and Rosin acids, hydrogenated, potassium salts by gavage. The only clinical effect noted was softened feces on the day following dosing. An additional 5 female rats were administered single oral gavage doses of 2000 mg/kg bw followed by a 14-day observation period. Under the conditions of this study, no deaths occurred and the oral LD50 value was determined to be > 2000 mg/kg bw. No abnormal clinical signs were observed in the rats dosed at 2000 mg/kg bw. Body weight gain was normal for all animals over the 14-day observation period. Based on the results of this study, Resin acids and Rosin acids, hydrogenated, potassium salts is relatively harmless by the oral route.
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