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EC number: 279-348-2 | CAS number: 79915-74-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD series on testing and assessment no. 160
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-isopropoxyethyl salicylate
- EC Number:
- 279-348-2
- EC Name:
- 2-isopropoxyethyl salicylate
- Cas Number:
- 79915-74-5
- Molecular formula:
- C12H16O4
- IUPAC Name:
- 2-(propan-2-yloxy)ethyl 2-hydroxybenzoate
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: Clear colorless liquid
- Storage Conditions: Room temperature, in the dark
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test system: isolated corneas from the eyes of freshly slaughtered bovine.
Age of animals: 6-12 months
Transport solution: Hanks balanced salt solution (HBSS) Modified supplemented with Penicillin sulphate and Streptomycin
sulphate.
Transport conditions: in transport solution at approximately 4°C.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.750 mL of the test item was tested as supplied (being a liquid non surfactant) on the epithelial surface of three idoneous bovine corneas.
- Duration of treatment / exposure:
- Corneas were exposed in horizontal position for an exposure period of 10 minutes.
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Details on study design:
- Positive control item was 100% (v/v) dimethylformamide (Labelled as N,NDimethylformamide, Sigma, batch no. SZBD0800V).
Negative control item was Physiological saline (0.9% NaCl) (Baxter, batch no. 13D0406).
Volume of treatment: 0,75 mL
Number of replicates: 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 0.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 95.5
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0
- Negative controls validity:
- valid
- Remarks:
- 0.0
- Positive controls validity:
- valid
- Remarks:
- 82.3
- Irritation parameter:
- other: calculated permeability
- Run / experiment:
- mean
- Value:
- 0.019
- Negative controls validity:
- valid
- Remarks:
- 0.0067
- Positive controls validity:
- valid
- Remarks:
- 0.8823
- Other effects / acceptance of results:
- At the macroscopic observation, no visible change of the treated corneas was noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vitro eye irritancy test performed according to OECD/EC guidelines and GLP principles, it is concluded that Sakura Salicylate is non corrosive or irritant to the eye.
- Executive summary:
The potential of Sakura Salicylate to cause corrosion/ severe irritation was tested by using the Bovine Corneal Opacity and Permeability (BCOP) assay, according to OECD/EC guidelines and GLP principles. The test item was tested as supplied (being a liquid non surfactant) on the epithelial surface of three idoneous bovine corneas. Positive and negative controls (100% (v/v) dimethylformamide and physiological saline alone, respectively) were concurrently tested in the same number of replicates. The mean opacity of the corneas treated with the test item, detected with an opacitometer at the end of the 2-hour post-exposure period, was 0.0. At the macroscopic observation, no visible change of the treated corneas was noted. After the determination of opacity, the epithelial surface was treated with a 0.4% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability. The calculated mean permeability OD490 value of the corneas treated with the test item was 0.0190. The calculated in vitro irritancy score (IVIS) for the test item was 0.3. Negative and positive controls gave the expected results. Based on these results it is concluded that the test item is non corrosive or irritant to the eye, and is not classified for eye irritancy according to Regulation (EC) 1272/2008.
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