Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- 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 material
- Reference substance name:
- Sorbitan, tridocosanoate
- EC Number:
- 301-037-8
- EC Name:
- Sorbitan, tridocosanoate
- Cas Number:
- 93980-59-7
- Molecular formula:
- C72H138O8
- IUPAC Name:
- Sorbitan tridocosanoate
Constituent 1
In vitro test system
- 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
Results and discussion
In vitro
Resultsopen allclose all
- 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%)
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
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.