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EC number: 944-825-2 | 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

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- Ocular Irretection Assay system
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: Ocular Irritection® assay system
- Principles of method if other than guideline:
- The Ocular Irretection (OI) assay system is a quantitative in vitro test method that mimics acute ocular irritation test. This method is able to evaluate the potential of a test substance to cause eye irritation and corneal opacity by measuring the optical density produced by the interaction of the test substance with a mixture of proteins and glycoproteins. The basis is that the interaction of an irritating agent with cornea causes denaturation and/or disruption of local proteins. So, during the test, the induced alterations in the proteins structures are measured with the differences in turbidity of the reagents matrix at 405 nm using a spettrometer. The interpretation of results is performed by a software that compares the optical density produced by the test substance with a standard curve obtained by a set of calibration well known substances. This standard curve of calibration relates to the ocular potential in the in vivo Draize rabbits eye test. The irritancy potential of a test substance is expressed as an Irritatition Draize Equivalent (IDE) score (0-50), that is obtained by comparison of results of calibration standards with correspondent in vivo studies.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- lot/batch: ESTER B/1 FU 150211
- Species:
- other: Ocular Irritation Assay measures the optical density produced by the interaction of the test substance with a mixture of proteins and glycoproteins
- Details on test animals or tissues and environmental conditions:
- mixture of proteins and glycoproteins
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 75, 100, 125 micrograms. - Duration of treatment / exposure:
- 24h
- Irritation parameter:
- other: Irritection Draize Equivalent
- Value:
- 9.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- IDE score = 9.1
ESTER B is evaluated as minimal irritant by the OI assay system. - Executive summary:
ESTER B is evaluated as minimal irritant by the OI assay system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
ESTER B is evaluated as minimal irritant by the OI assay system.
Human patch test do not show evidence of skin irritation (see human studies).
Justification for classification or non-classification
The substance is not classified accordig CLP EU Regulation for eye irritation cause the outcome OI assay perfomed on Ester B.
Human patch test do not show evidence of skin irritation.
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