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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
Endpoint summary
Administrative data
Description of key information
The potential of Sakura Salicylate to be irritant to the skin was investigated through an in vitro skin irritation study, using a reconstructed human epidermis (RhE) model EPISKIN™ (Klimisch 1 study). Furthermore, the absence of skin effects in an acute dermal toxicity study and an in vivo LLNA study are considered.
A BCOP study is available to address eye effects of Sakura Salicylate (Klimisch 1 study).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2015 - February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Remarks:
- EPISKIN™
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ (Supplier: SkinEthic Laboratories, 4, A. Fleming – 69366 Lyon, France)
- Tissue batch number: 16-EKIN-004
The test system EPISKIN™ is a reconstructed human epidermis (RhE) model, which in its overall design (the use of human derived epidermis keratinocytes as cell source and use of representative tissue and cytoarchitecture) closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. The principle of the RhE test method is based on the premise that chemicals are able to penetrate the stratum corneum and irritant chemicals are cytotoxic to the cells in the underlying layers. Cell viability is measured by dehydrogenase conversion of the vital dye MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS N. 298-93-1] into a blue formazan salt that is quantitatively measured after extraction from tissues. Irritant chemicals are identified by their ability to decrease cell viability below defined threshold levels. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 20 µL/epidermis unit, each measuring 0.38 cm^2 (treatment level: 53 µL/cm^2).
- Duration of treatment / exposure:
- 15 +/- 0.5 minutes (in a ventilated cabinet at room temperature)
- Duration of post-treatment incubation (if applicable):
- 42 +/- 1 hour
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 72.8
- Vehicle controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 4.1%
- Other effects / acceptance of results:
- The test item did not induce relevant cell death in any replicate, with a mean cell viability of 72.8%, when compared to the negative control. Acceptable intra-replicate variability was obtained (SD of % viability = 12.3, i.e. lower than 18).
Before the main assay, a preliminary test was carried out to evaluate the compatibility of the test item with the test system. In a first step, the test item was assayed for the ability of reducing MTT per se. A colourless solution, with a sticky transparent precipitate was observed at the end of the incubation period, indicating no interaction with MTT. In a second step, the test item was assayed for the ability of colouring water per se. A transparent solution was observed indicating that the test item has no colour capabilities. Based on these results, no additional control was added in theMain Assay. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of a reliable in viro skin irritation test, it is concluded that Sakura Salicylate is classified as not irritant to the skin.
- Executive summary:
The potential of Sakura Salicylate to be irritant to the skin was investigated through an in vitro skin irritation study, using a reconstructed human epidermis (RhE) model EPISKIN™. The experimental procedures were according to OECD Guideline 439 and GLP principles. The test item was shown not to interfere with the test system and positive and negative controls (a 5% (w/v) SDS solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively) gave responses as expected. The test item did not induce relevant cell death in any replicate, with a mean cell viability of 72.8% when compared to the negative control. Intra-replicate variability was acceptable with an SD of % viability value equal to 12.3. Based on the results obtained, Sakura Salicylate is classified as not irritant to the skin according to Regulation (EC) 1272/2008.
Reference
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
- Adequacy of study:
- key study
- Study period:
- April - May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- 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. - 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 - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The potential of Sakura Salicylate to be irritant to the skin was investigated through an in vitro skin irritation study, using a reconstructed human epidermis (RhE) model EPISKIN™. The experimental procedures were according to OECD Guideline 439 and GLP principles. The test item was shown not to interfere with the test system and positive and negative controls (a 5% (w/v) SDS solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively) gave responses as expected. The test item did not induce relevant cell death in any replicate, with a mean cell viability of 72.8% when compared to the negative control. Intra-replicate variability was acceptable with an SD of % viability value equal to 12.3. It is furthermore considered that dermal exposure to Sakura Salicylate (undiluted) in an acute dermal toxicity test and in the in vivo LLNA study (undiluted) did not result in any adverse skin effects.
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
Justification for classification or non-classification
Taken all data together, Sakura Salicylate is classified as not corrosive and not irritant to the skin and eye according to Regulation (EC) 1272/2008.
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