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Diss Factsheets
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EC number: 915-568-3 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From 12 OCT 2004 to 15 OCT 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 404, EU Method B.4, and GLPs.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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:
- resin acids and rosin acids, hydrogenated, potassium salts
- 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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Source: Covance Research Products, Inc., Denver, PA
-Sex: not specified
-Acclimation period: 5 days
-Age at study initiation: at least 3 months old
-Housing: rabbits were individually housed in suspended, stainless-steel, wire-mesh cages
-Diet: Certified High Fiber Rabbit Diet (PMI #5325); ad libitum
-Water: local municipality, ad libitum
-Method of animal identification: uniquely-numbered ear tags and cage cards
ENVIRONMENTAL CONDITIONS:
-Temperature (°C): 21.1-23.3
-Humidity (%): 43.2-61.9
-Photoperiod: 12 hours light/12 hours dark cycle
IN-LIFE DATES:
-Experimental start date: 2004-10-12
-Experimental completion date: 2004-10-15
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin adjacent to the test site served as the control for each animal.
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after removal of the occlusive patch
- Number of animals:
- 3
- Details on study design:
- PRE-TEST ACTIVITIES:
Prior to initiation of the dermal irritation study, a screening procedure was performed. First the pH of the test substance was measured and the value obtained (10.307) demonstrated that the test substance was neither strongly acid (pH ≤ 2.0) nor strongly alkaline (pH ≥ 11.5). Subsequently, an in vitro test (Corrositex Assay) designed to identify substances that are corrosive to the skin was conducted. The results of this test suggested that the test substance was non-corrosive.
APPLICATION OF TEST SUBSTANCE:
Prior to treatment, an area of the dorsal skin was shaved with an electric clipper. The test substance was moistened thoroughly with water and a single dose of 0.5 g of the test substance was applied to the shaved area with a fiber pad. An occlusive wrap was applied to hold the test substance in contact with the skin for four hours. After 4 hours, the bandage was removed and the application site rinsed with running water.
OBSERVATIONS:
The site of application was examined at 1, 24, 48, and 72 hours after removal of the occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar formation, scarring, erosion, and stains caused by the test substance as well as general systemic effects. At the end of the observation period, the animals were euthanized and discarded without necropsy.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: all timepoints
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No erythema was noted in any animal at any timepoint.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: all timepoints
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema was noted in any animal at any timepoint.
- Irritant / corrosive response data:
- No erythema or edema was noted in any animal at any time during the study.
- Other effects:
- No toxicity or abnormal behaviors were noted in any animal during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Resin acids and Rosin acids, hydrogenated, potassium salts is not a primary skin irritant. No signs of erythema or edema were observed on rabbit skin when the test material was applied to intact skin under occluded contact for 4 hours.
Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for Skin Irritation/Corrosion according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for skin irritation in Annex I of Directive 67/548/EEC. - Executive summary:
In a dermal irritation study, three New Zealand White rabbits were each exposed to 0.5 g of Resin acids and Rosin acids, hydrogenated, potassium salts moistened with water and applied to the shaved skin of the back for four hours under occluded contact. After removal of the occlusive dressings, the animals were observed for a total of 3 days for signs of primary irritation (erythema and edema). During the observation period, the test substance did not cause any erythema or edema. Under the study conditions, Resin acids and Rosin acids, hydrogenated, potassium salts is not considered to be a skin irritant in New Zealand White rabbits.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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