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Diss Factsheets
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EC number: 268-884-2 | CAS number: 68153-38-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- 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
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality, clinical signs, dermal reactions or gross pathology observed.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: other: No dermal reactions nor systemic clinical signs were observed
- Gross pathology:
- The gross pathogy examination did not reveal treatment- related changes.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of the test material Resin acids and rosin acids, hydrogenated methyl ester is >2000 mg/kg/bw.
- Executive summary:
This data is being read across from the source study that tested Resin acids and Rosin acids, hydrogenated, methyl esters based on category read across that is explained in the category justification document attached in Section 13 of the dossier.
In an acute dermal toxity study, a single treatment of 2000 mg/kg/bw of Resin acid and rosin acid, hydrogenated methyl ester was applied to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) for 24 hrs under semi-occlusion. Under the conditions of the study, no mortality occurred and no dermal reactions or systemic clinical signs observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acids and rosin acids, hydrogenated methyl ester was >2000 mg/kg/bw.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Resin acids and Rosin acids, hydrogenated methyl ester
- IUPAC Name:
- Resin acids and Rosin acids, hydrogenated methyl ester
- Reference substance name:
- Resin acids and Rosin acids, hydrogenated, Me esters
- EC Number:
- 232-476-2
- EC Name:
- Resin acids and Rosin acids, hydrogenated, Me esters
- Cas Number:
- 8050-15-5
- Molecular formula:
- Not applicable for UVCB constituents
- IUPAC Name:
- Resin acids and Rosin acids, hydrogenated, Me esters
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Foralyn (TM) 5020-F Ester of Hydrogenated Rosin
- Substance type: UVCB
- Physical state: liquid
- Colour: yellow
- Quantity: 1000.89 g (container+ contents)
- Analytical purity: 100%
- Lot/batch No.: KM001
- Expiration date of the lot/batch: 2013/01/06
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier (53940 Le Genest St Isle- France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: 220-224 g
- Fasting period before study:
- Housing: individual cages with solid-bottomed clear polycarbonate cages with a stailess steel mesh lid. Each cage contained dust free weed shavings which were changed at least 2 times a week.
- Diet (e.g. ad libitum): foodstuff (M20-SDS) freely available
- Water (e.g. ad libitum): tap water from public distribution system
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 70%
- Air changes (per hr): 10-15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 100%
- Type of wrap if used: porous gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated areas were rinsed with distilled water after 24 hrs exposure period
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg/bw (according to the calculated density)
- Dose: 2000 mg/kg/bw - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg/bw
- No. of animals per sex per dose:
- 5 male rats and 5 female rats
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily: systematic examination were carried out daily to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. Periodical: Animals were weighed on D0, D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality, clinical signs, dermal reactions or gross pathology observed.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: other: No dermal reactions nor systemic clinical signs were observed
- Gross pathology:
- The gross pathogy examination did not reveal treatment- related changes.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of the test material Resin acids and rosin acids, hydrogenated methyl ester is >2000 mg/kg/bw.
- Executive summary:
In an acute dermal toxity study, a single treatment of 2000 mg/kg/bw of Resin acid and rosin acid, hydrogenated methyl ester was applied to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) for 24 hrs under semi-occlusion. Under the conditions of the study, no mortality occurred and no dermal reactions or systemic clinical signs observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acids and rosin acids, hydrogenated methyl ester was >2000 mg/kg/bw.
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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