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EC number: 269-130-5 | CAS number: 68187-85-9
- 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:
- 04 - 11 Jun 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted Jun 2018
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, esters with ethylene glycol
- EC Number:
- 269-130-5
- EC Name:
- Fatty acids, tall-oil, esters with ethylene glycol
- Cas Number:
- 68187-85-9
- Molecular formula:
- C38H66O4 C38H64O4 C40H68O4 C40H70O4 C38H68O4
- IUPAC Name:
- 2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z)-octadec-9-enoate; 2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z,12Z)-octadeca-9,12-dienoate; 2-[(9Z,12Z)-octadeca-9,12-dienoyloxy]ethyl (9Z,12Z)-octadeca-9,12-dienoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKIN Small Model™
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small Model™
- Tissue batch number(s): 18-EKIN-023, 18-EKIN-015 and 18-EKIN-022
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: at room temperature
- Temperature of post-treatment incubation: at 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The tissues were washed with phosphate buffered saline to remove residual test substance.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Barrier function: According to the Supplier`s Data Sheet, the IC50 value was determined to be 2.1 and 2.2 mg/mL for the tissues with the batch numbers of 18-EKIN-023 and 18-EKIN-015 (acceptance criteria: 1.5 ≤ IC50 ≤ 3.0), respectively. The result of the tissue with the batch number 18-EKIN-022 was invalid.
NUMBER OF REPLICATE TISSUES: 3 tissues were used per treatment, negative and positive control, respectively.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues : Since the test item reacted with the MTT medium, in addition three killed tissues treated with test item and three killed untreated tissues were used for the cytotoxicity evaluation with MTT (Batch numbers: 18-EKIN-015 and 18-EKIN-022).
- Procedure used to prepare the killed tissues: Living epidermis was transferred to 12 well plates and incubated with 2 mL Milli-Q for 48 ± 1 h. After incubation, killed epidermis was stored at ≤ -15°C. Killed tissues were thawed by placing them for 1 h at room temperature in 12 well plates on 2 mL maintenance medium. Further use of killed tissues was similar to living tissues.
- N. of replicates: 3
- Method of calculation used:
Nonspecific MTT reduction (NSMTT) was calculated. NSMTT is the difference between the mean OD of the untreated killed tissues (ODkt_u+MTT) and test item treated killed tissues (ODkt_t+MTT) expressed as percentage of the mean of the negative control tissues (ODlt_u+MTT).
%NSMTT = [(ODkt_t+MTT – ODkt_u+MTT)/ mean ODlt_u+MTT] * 100
True tissue viability is calculated as the difference between the living test item treated tissues incubated with MTT medium (ODlt_t+MTT) and the difference between ODkt_t+MTT and ODkt_u+MTT.
OD= ODlt_t+MTT – (ODkt_t+MTT-ODkt_u+MTT)
%Viability = [OD/ mean ODlt_u+MTT] * 100
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: Duplicate measurements each of 3 independent tissues
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant or corrosive (category 1 or 2) to skin if after 15 min exposure and 42 h of post incubation is less than or equal to 50%.
- The test substance is considered to be non-irritant (no category) to skin if after 15 min exposure and 42 h of post incubation is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 µL
NEGATIVE CONTROL
- Amount(s) applied: 25 µL
POSITIVE CONTROL
- Amount(s) applied: 25 µL
- Concentration: 5% (aq) sodium dodecyl sulfate in phosphate buffered saline - Duration of treatment / exposure:
- 15 ± 0.5 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- Duplicate measurements each of 3 independent tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 ± 0.5 min exposure with the test item
- Value:
- 69
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction and colour interference with MTT: The test item was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because a color change was observed by adding MTT-medium it was concluded that the test item did interact with the MTT endpoint. In addition to the normal procedure, three killed tissues treated with test item and three killed non-treated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by the test item was 0.64% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test item treated viable tissues.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the OD values of the three independent tissues for the negative control were 1.3171, 1.2761, 1.0732, 1.0738, 1.0012 and 0.9437, and thus within the range of the istorical control data (0.422 - 1.547).
- Acceptance criteria met for positive control: Yes, the positive control reduced the cell viability at 3.6 % and fulfilled the acceptance criteria.
- Acceptance criteria met for variability between replicate measurements: Yes, differences of three tissue cell viabilities in the negative control substance, the positive control substance and the test substance groups were 15%, 14% and 0.8%, respectively, and thus ≤ 18%.
Any other information on results incl. tables
Table 1: Individual absorption values
Tissue A | Tissue B | Tissue C | |
(OD570) | (OD570) | (OD570) | |
Negative control measurement 1 |
13.171 | 10.732 | 10.012 |
Negative control measurement 2 |
12.761 | 10.738 | 0.9437 |
Test item on viable tissue OD570measurement 1 | 0.8058 | 0.9558 | 0.6488 |
Test item on viable tissue OD570measurement 2 | 0.7956 | 0.9267 | 0.6155 |
Test item on killed tissue OD570measurement 1 | 0.1190 | 0.1076 | 0.1505 |
Test item on killed tissue OD570measurement 2 | 0.1203 | 0.1197 | 0.1391 |
Non treated killed tissue OD570measurement 1 | 0.0993 | 0.1442 | 0.1296 |
Non treated killed tissue OD570measurement 2 | 0.0939 | 0.1317 | 0.1166 |
Positive control OD570measurement 1 | 0.0807 | 0.0874 | 0.0726 |
Positive control OD570measurement 2 | 0.0826 | 0.0924 | 0.0716 |
OD: Optical density
SD: Standard Deviation
1) The test item values were corrected fot the non-specific MTT reaction (0.64%)
Table 2: Mean tissue viability (%)
|
Mean tissue viability (% of control) |
Standard deviation (%) |
Negative control |
100 |
15 |
Test item |
69 |
14 |
Positive control |
3.6 |
0.8 |
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
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