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EC number: 301-037-8 | CAS number: 93980-59-7
- 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
Skin irritation (OECD 439): not irritating
Eye irritation (OECD 437): not irritating
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:
- 25 - 28 Sep 2017
- 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)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: Keratinocyte Strain: 4F0219
- Justification for test system used:
- reccomended in TG OECD 439
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Tissue was wetted with 25 µL of PBS prior to exposure
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epiderm TM Reconstructed Human Epidermis, EPI-200, EPI-212
- Tissue batch number(s): 27124
- Production date: 27 Sep 2017 (Date of Certificate of Analysis)
- Date of initiation of testing: 25 Sep 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C, humid, 5% CO2 (incubator), then room temperature
- Temperature of post-treatment incubation: not provided
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissue was rinsed 15 times with PBS(-), then they were 3 times completely submerged in 150 mL PBS(-) and once rised from inside and outside with PBS(-); Remaining PBS(-) was removed from the inside and outside of the tissue insert with a sterile cotton swab before transferring the tissues into the wells with fresh medium.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 180 ± 5 min
- Spectrophotometer: FLUOstar OPTIMA, BMG LABTECH
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.802 ± 0.057
- Barrier function: test was passed
- Morphology: well-differentiated epidermis consisting of a viable basal layer, intermediate spinous and granular layers and a functional stratum corneum
- Contamination: no
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA:
- The test substance is considered to be corrosive or irritant to skin if the mean relative viability after 60 minutes exposure is less or equal to 50% of the negative control.
- The test substance is considered to be non-corrosive or non irritant to skin if the viability after 60 minutes exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg
NEGATIVE CONTROL
- Amount(s) applied: 30 µL
- Concentration: undiluted
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration: 5% - Duration of treatment / exposure:
- 60 min (35 min at 37°C and 25 min at room temperature)
- Duration of post-treatment incubation (if applicable):
- 24 ± 2 h, after transfer to lower wells containing fresh medium further 18 ± 2 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of positive control (5% SDS)
- Value:
- 1.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of test substance
- Value:
- 98.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (mean OD = 2.348)
- Acceptance criteria met for positive control: yes (mean viability = 1.9%)
- Acceptance criteria met for variability between replicate measurements: yes (0.2 - 3.2%) - Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Reference
Table 1: Results MTT assay after 3 h ± 5 min exposure
Substance |
Tissue No. |
OD570 |
OD570 (mean per tissue) |
OD570 (mean of 3 tissues) |
Cell viability [%] |
Cell viability (mean) [%] |
Standard Deviation of cell viability [%] |
Negative Control |
1 |
2.409 |
2.385 |
2.348 |
101.6 |
100.0 |
1.4 |
2.36 |
|||||||
2 |
2.376 |
2.338 |
99.6 |
||||
2.299 |
|||||||
3 |
2.364 |
2.322 |
98.9 |
||||
2.280 |
|||||||
Positive Control |
1 |
0.046 |
0.046 |
0.044 |
2.0 |
1.9 |
0.2 |
0.046 |
|||||||
2 |
0.041 |
0.041 |
1.7 |
||||
0.04 |
|||||||
3 |
0.047 |
0.045 |
1.9 |
||||
0.042 |
|||||||
Test substance |
1 |
2.381 |
2.348 |
2.313 |
100.0 |
98.5 |
3.2 |
2.314 |
|||||||
2 |
2.389 |
2.364 |
100.7 |
||||
2.338 |
|||||||
3 |
2.261 |
2.227 |
94.8 |
||||
2.192 |
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:
- 25 Sep 2017
- 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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Hokkaido Livestock Corporation, Douo Plant, Hayakita Factory
- Number of eyeballs: 30, 12 used in the study
- Characteristics of donor animals: 12 months to less than 60 months old, healthy
- Storage, temperature and transport conditions of ocular tissue: The collected eyeballs were immersed in Hanks' balanced salt solution, and stored and transported at less than 20°C until use in the test (temperature range during transportation: 12 - 14°C).
- Time interval prior to initiating testing: same day
- Indication of any existing defects or lesions in ocular tissue samples: no - Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: 10% (w/v)
VEHICLE
- Amount(s) applied: 8 mL
- Concentration: undiluted
- Lot/batch no.: K7D7 - Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- triplicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: A careful macroscopic examination was performed on all eyes to detect the presence of any defects (corneal opacity, scratches, neovascularization etc). Any eyes with defects were discarded. The corneas were dissected with a 2 to 3 mm rim of the sclera remaining, and were immersed in Hanks' balanced salt solution (HBSS). The corneae were directly used in the BCOP test on the same day.
QUALITY CHECK OF THE ISOLATED CORNEAS : Eyes were free of defects.
NUMBER OF REPLICATES : 3
SOLVENT CONTROL USED: yes, distilled water
POSITIVE CONTROL USED : yes, Dimethylformamide
APPLICATION DOSE AND EXPOSURE TIME : 750 μL test item (10%), 10 min
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times with phenol red-containing MEM and 1 time with phenol red-free MEM
- POST-EXPOSURE INCUBATION: yes, 2 h
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured using the opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the TG (OECD 437) was used.
STUDY ACCEPTANCE CRITERIA: The following study acceptance criteria described in OECD TG 437 were adopted:
A test is considered acceptable if the IVIS of the positive control is within 2 standard deviations of the latest historical control mean. A test is considered acceptable if the opacity and permeability values of the negative control are less than the upper limit of opacity and permeability values of the historical control data obtained from the bovine corneas treated with the negative control. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- Negative control (Mean corrected final opacity)
- Value:
- 0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- (Permeability)
- Run / experiment:
- Negative control (Mean corrected OD490 change)
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Negative control
- Value:
- 0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test substance (Mean corrected final opacity)
- Value:
- -0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- (Permeability)
- Run / experiment:
- Test substance (Mean corrected OD490 change)
- Value:
- -0.001
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test substance
- Value:
- -0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Positive control (Mean corrected final opacity)
- Value:
- 95.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- (Permeability)
- Run / experiment:
- Positive control (Mean corrected OD490 change)
- Value:
- 0.77
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Positive control
- Value:
- 107.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
not demonstrated in the study report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline:
Opacity
Negative control: -2.0 - 2.4
Positive control: 38.0 - 111.0
Permeability
Negative control: -0.003 - 0.027
Positive control: 0.171 - 1.708
IVIS:
Negative control: -2.0 - 2.4
Positive control: 42.3 - 128.0 (mean ± 2SD: 67.4 ~ 128.2) - Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation in vitro
Sorbitan tridocosanoate was investigated for its skin irritation potential in epidermal keratinocytes in vitro using reconstructed human epidermis. The test was conducted with the EpiDerm™ (EPI-200, EPI-212) model according to OECD guideline 439 and in compliance with GLP (Riken Vitamin, 2017a).
25 µL of the undiluted test item, the negative control (phosphate buffered saline, PBS) and the positive control (5% sodium dodecyl sulfate, SDS) were applied topically to the surface of the tissues and incubated for a total of 60 min (35 min at 37 °C followed by 25 min at room temperature). After exposure and 42 h of post-incubation at 37 °C, cytotoxicity was evaluated by MTT reduction. The test item was known to not colour-interfere with water and not directly reduce MTT. All acceptability criteria of the test were met.
When compared to the mean relative tissue viability of the solvent control, the mean relative tissue viability of sorbitan tridocosanoate after 60 min of exposure was 98.5%. This value is above the threshold for irritancy of ≤50%. Therefore, under the conditions of the test, the test item is considered to be non-irritant to the skin.
Eye irritation in vitro
The eye irritating potential of sorbitan tridocosanoate was investigated using a bovine corneal opacity and permeability (BCOP) test in vitro. The BCOP test was conducted according to OECD guideline 437 and in compliance with GLP (Riken Vitamins, 2017b). After an initial opacity reading, the test item was prepared as 10% (w/v) formulation in distilled water. 750 µL of test substance formulation, solvent (water) or positive control (dimethylformamide) were applied onto the epithelium of each three corneas for 10 min, followed by 2 h of post-exposure incubation. Afterwards, a second opacity reading was performed. In addition, permeability of the corneas was evaluated by measuring the transfer of sodium fluorescein.
All acceptability criteria of the test were met, demonstrating the sensitivity and validity of the test system.
Relative to the negative control, the calculated mean in vitro irritancy score (IVIS) of sorbitan tridocosanoate was -0.7. Based on the experimental findings and under the conditions of the test, the test item is not considered irritant to the eye.
Justification for classification or non-classification
The available data on skin irritation/corrosion and eye irritation/corrosion do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
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