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EC number: 305-515-7 | CAS number: 94581-16-5
- 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
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Endpoint summary
Administrative data
Description of key information
Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Adequate information exists to characterise the acute toxicity of Rosin adduct esters. These are formed after modification of rosin with either fumaric acid or maleic anhydride followed by esterification with glycerol and/or pentaerythritol, and hence the adduct ester products therefore exhibit close structural similarities. The available data includes results of tests conducted using Resin acids and rosin acids, fumarated, esters with glycerol; Resin acids and rosin acids, maleated, esters with pentaerythritol; Resin acids and rosin acids, fumarated, esters with pentaerythritol; and Rosin, fumarated, reaction products with glycerol and pentaerythritol. This information is summarised below.
Acute Oral Toxicity
In an acute oral toxicity in the rats (Laboratoire Biogir S.A, 1994), Dertoline MG (Resin acids and rosin acids, fumarated, esters with glycerol) in paraffin oil was orally administered via gavage to Sprague-Dawley rats (5/sex) at a treatment level of 2000 mg/kg bw. The animals were then observed over a period of 14 days for mortality and signs of clinical toxicity. Based on an absence of test material related mortality and lack of adverse signs of clinical toxicity, the acute oral LD50 for Dertoline MG (Resin acids and rosin acids, fumarated, esters with glycerol) was considered to be >2000 mg/kg body weight in the rat.
In an acute oral toxicity study with Alresat KM 140 (Resin acids and rosin acids, fumarated, esters with glycerol), the test substance was administered via oral gavage to Sprague-Dawley rats (5/sex) at a dose of 2000 mg/kg bw in Sesamol (Hoechst Pharma Entwicklung Toxikologie, 1992). The animals were observed over a period of 14 days for mortality and signs of clinical toxicity. Based on an absence of test material related mortality and lack of adverse signs of clinical toxicity, the acute oral LD50 for Alresat KM 140 (Resin acids and Rrsin acids, fumarated, esters with glycerol) was considered to be >2000 mg/kg body weight in the rat.
The acute oral toxicity of Rosin, fumarated, reaction product with glycerol and pentaerythritol was evaluated in a study conducted according to OECD Guideline 423 (Phycher Biodeveloppment, 2010). Six female rats were each administered a single dose of 2000 mg/kg bw of the test substance by gavage. All animals survived to study termination. All animals gained weight normally and there were no signs of systemic toxicity. The acute oral LD50 in this study was >2000 mg/kg bw for female rats.
In an acute toxicity that examined UNI-REZ 7059 (Resin acids and rosin acids, maleated, esters with pentaerythritol) five male and five female rats received a single dose of the test substance at 5000 mg/kg bw (Food & Drug Research Laboratories, Inc., 1985a). Animals were then observed for 15 days. No mortality was observed. The acute oral LD50 in this study was > 5000 mg/kg bw for male and female rats.
In the other acute toxicity study, a single dose of UNI-REZ 757 (resin acids and rosin acids, fumarated, esters with glycerol; CAS No. 97489-11-7) was administered to five males and five females via gavage at 5000 mg/kg (Food & Drug Research Laboratories, Inc., 1985b). Animals were then observed for 15 days. No mortality was observed. The acute oral LD50 in this study was > 5000 mg/kg bw for male and female rats.
Acute Dermal Toxicity
In an acute dermal toxity study, Resin acid and rosin acids, fumarated, ester with pentaerythritol was applied at a treatment level of 2000 mg/kg bw to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) for 24 hrs under semi-occlusion (Phycher Bio Developpement, 2012). Under the conditions of the study, no mortality occurred and no dermal reactions or systemic clinical signs were observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acid and rosin acids, fumarated, esters with pentaerythritol was >2000 mg/kg/bw.
Acute Inhalation Toxicity
No studies were available for review. A low vapour pressure indicates that exposure via this route is unlikely.
Justification for classification or non-classification
Not classified for acute lethality by oral or dermal routes of exposure under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. For non-EU countries, 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 to provide a definitive classification under UN GHS for acute oral toxicity. The physico-chemical properties of the category members indicate no requirement for classification with regard of aspiration hazard (kinematic viscosity exceeds 20.5 mm2/s at 40°C).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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