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EC number: 268-820-3 | CAS number: 68140-98-7
- 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:
- 13 December 2017-10 April 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol
- EC Number:
- 268-820-3
- EC Name:
- 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol
- Cas Number:
- 68140-98-7
- Molecular formula:
- C23H43NO2
- IUPAC Name:
- 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol
- Test material form:
- liquid
- Details on test material:
- Name: Oxazolin (A 45 A)
Chemical name (name used in the study): 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol
Batch No.: UR010-076
Molecular Formula: C23H43NO2
Molecular Weight: 365.59 g/mol
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiSkinTMSM, EPISKIN SNC Lyon, France.
- Details on animal used as source of test system:
- Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV
collagen. - Justification for test system used:
- The EPISKIN model has been validated for irritation testing in an international trial. After a review of scientific reports and peer reviewed publications on the EPISKIN method, it showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation, when the endpoint is evaluated by MTT reduction and for being used as a replacement for the Draize Skin Irritation test (OECD TG 404 and Method B.4 of Annex V to Directive 67/548/EEC) for the purposes of distinguishing between skin irritating and no skin irritating test substances (STATEMENT OF VALIDITY OF IN-VITRO TESTS FOR SKIN IRRITATION; ECVAM; Institute for Health & Consumer Protection; Joint Research Centre; European Commission; Ispra; 27 April 2007).
- Details on test system:
- Disks of epidermal units (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test material was terminated by rinsing the epidermal units with 1x PBS solution. Epidermis units were then incubated at 37±1 °C for 42 hours in an incubator with 5±1 % CO2. The viability of each disk was assessed by incubating the tissues for 3 (±5 min) hours with MTT solution at 37±1 °C in 5±1 % CO2 and protected from light. The resulting formazan crystals were extracted with acidified isopropanol and quantified with the optical densities (OD) recorded spectrophotometrically.
SDS 5 % aq. and 1 x PBS treated (three units / positive and negative control) epidermis units were used as positive and negative controls, respectively. For each treated tissue, viability was expressed as a percentage relative to negative control.
The test item has an intrinsic colour (brown), therefore two additional test item treated tissues were used for the non-specific OD evaluation.
The test item is a possible MTT-reducer, therefore additional controls (test item treated killed tissues and negative control treated killed
tissues) were used to detect and correct for test substance interference with the viability measurement.
The test item is a possible MTT-reducer and has an intrinsic colour (brown). To avoid a possible double correction [TODTT (MTT and
NSC)] for colour interference, a third control for non-specific colour in killed tissues (NSCkilled) was performed. Two killed treated tissues were used to avoid a possible double correction for colour interference. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 μL undiluted test item
Application (day 0):
- Test Item
A volume of 10 μL undiluted test item was applied evenly to the epidermal surface of each of the three test skin units.
- Positive and negative control
A volume of 10 μL positive control (SDS 5 % aq.) or negative control (1 x PBS) was applied to the skin surface by using a suitable pipette. - Duration of treatment / exposure:
- Exposure (day 0): The plates with the treated epidermis units were incubated for the exposure time of 15 minutes at room temperature.
- Duration of post-treatment incubation (if applicable):
- Post-incubation (day 0-2):
After rinsing the units were placed into the plate wells filled with fresh pre-warmed “maintenance medium” (2 mL/well)
below them and then incubated for 42 hours at 37±1°C in an incubator with 5±1 % CO2, ≥ 95 % humidified atmosphere. - Number of replicates:
- Number of replicate wells:
- 3 replicates per test item
- 3 replicates negative controls,
- 3 replicates positive controls,
- 2 replicates colour controls and 2 replicates non-specific colour control
- 3 killed treated tissues and 3 killed negative control tissues (for the MTT evaluation)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item
- Value:
- > 77 - < 93
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Cell viability
The results of the optical density (OD) measured at 570 nm of each replicate and the calculated % viability of the cells are presented below:
OD values and viability percentages of the controls:
Substance |
Optical Density (OD) |
Viability (%) |
|
Negative Control:1x PBS |
1 |
1.12818 |
98 |
|
2 |
1.26353 |
109 |
|
3 |
1.07298 |
93 |
|
mean |
1.15490 |
100 |
standard deviation (SD) |
8.49 |
||
Positive Control:SDS (5 % aq.) |
1 |
0.09848 |
9 |
|
2 |
0.06408 |
6 |
|
3 |
0.06213 |
5 |
|
mean |
0.07490 |
6 |
|
standard deviation (SD) |
1.77 |
OD values and viability percentages of the test item (including corrected values):
Test Item |
Optical Density (OD) |
TODTT |
Viability (%) |
Relative Viability (%) |
|
4-ethyl-2- (8-heptadecenyl)-2- oxazoline-4- methanol |
1 |
0.90010 |
0.89788 |
78 |
78 |
|
2 |
1.07165 |
1.06943 |
93 |
93 |
|
3 |
0.88670 |
0.88448 |
77 |
77 |
|
mean |
0.952817 |
0.95060 |
83 |
82 |
|
standard deviation (SD) |
|
8.93 |
8.93 |
OD values of additional controls for MTT-interacting test item:
Additional controls |
Optical Density (OD) |
|
Negative control killed tissues:1x PBS |
1 |
0.10193 |
|
2 |
0.05473 |
|
3 |
0.05963 |
|
mean |
0.07210 |
Test item treated killed tissues:4-ethyl-2-(8-heptadecenyl)-2- oxazoline-4-methanol |
1 |
0.05955 |
|
2 |
0.10325 |
|
3 |
0.06015 |
|
mean |
0.07432 |
OD values and NSC % of additional control:
Additional colour control |
Optical Density (OD) |
Non Specific Colour %(NSC %) |
|
4-ethyl-2-(8-heptadecenyl)-2- oxazoline-4-methanol(test item treated tissues without MTT incubation) |
1 |
0.00905 |
2.8 |
|
2 |
0.05575 |
|
|
mean |
0.03240 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin
irritation potential under the utilized testing conditions. According to the current OECD Guideline No. 439, 4-ethyl-2-(8-
heptadecenyl)-2-oxazoline-4-methanol is considered as non-irritant to skin and is therefore not classified. - Executive summary:
The purpose of this study was to determine the skin irritation potential of the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol on reconstituted human epidermis in the EPISKIN model in vitro.
Disks of epidermal units (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test material was terminated by rinsing the epidermal units with 1x PBS solution. Epidermis units were then incubated at 37±1 °C for 42 hours in an incubator with 5±1 % CO2. The viability of each disk was assessed by incubating the tissues for 3 (±5 min) hours with MTT solution at 37±1 °C in 5±1 % CO2 and protected from light. The resulting formazan crystals were extracted with acidified isopropanol and quantified with the optical densities (OD) recorded spectrophotometrically.
SDS 5 % aq. and 1 x PBS treated (three units / positive and negative control) epidermis units were used as positive and negative controls, respectively. For each treated tissue, viability was expressed as a percentage relative to negative control.
The test item has an intrinsic colour (brown), therefore two additional test item treated tissues were used for the non-specific OD evaluation.
The test item is a possible MTT-reducer, therefore additional controls (test item treated killed tissues and negative control treated killed tissues) were used to detect and correct for test substance interference with the viability measurement.
The test item is a possible MTT-reducer and has an intrinsic colour (brown). To avoid a possible double correction [TODTT (MTT and NSC)] for colour interference, a third control for non-specific colour in killed tissues (NSCkilled) was performed. Two killed treated tissues were used to avoid a possible double correction for colour interference.
The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1), if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50 % when compared to the viability values obtained from the negative control.
In this in vitro skin irritation test using the EPISKIN model, the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol did not show significantly reduced cell viability in comparison to the negative control (mean relative viability: 82 %). All obtained test item viability results were above 50 % when compared to the viability values obtained from the negative control. Therefore the test item was considered to be non-irritant to skin.
Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
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