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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- OEDC 437
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2018-November 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 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)
- 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:
- CAS No. 68140-98-7
EINECS-No. 268-820-3
Molecular formula C23H43NO2
Molecular weight 365.59 g/mol
Vapour pressure < 0.001 hPa, 20 °C
Stability Stable under normal conditions
Solubility < 0.05 g/L, not soluble
Production date 01. Sep. 2017
Batch no. # 170903
Composition 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol
Purity 80.6 %
Homogeneity homogeneous
Expiry date 31. Aug. 2019
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 μg/mL) in a suitable cooled container within 1 hour.
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): without dilution
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): Hank’s Balanced Salt Solution (HBSS) 10-fold concentrated, diluted in demin. water (1:10), batch no.: 20180607
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): Dimethylformamide, DMF, CAS-No. 68-12-2, undiluted, batch no.: 475235719 - Duration of treatment / exposure:
- Exposure time of test item on corneas: 10 minutes at 32 ± 1 °C.
- Number of animals or in vitro replicates:
- three replicates
- Details on study design:
- Closed Chamber Method
The respective substance (negative control solution, test item or positive control) was applied by pipetting 750 μL of the appropriate liquid through the refill hole in the holder on the cornea. The test item was given on the epithelium in such a manner that as much as possible of the cornea was covered with the test item.
Exposure time of the test item on the corneas was 10 minutes at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 hours at 32 ± 1 °C (post-incubation).
After post-incubation time, the cMEM without phenol red was renewed in both chambers. Then, the final opacity value of each cornea was recorded.
Permeability Test
After the recording of the final opacity value, the cMEM without phenol red was removed from the front chamber, and 1 mL sodium fluorescein solution was added to the front chamber for the detection of permeability of the corneas.
For the closed chamber method, a sodium fluorescein solution with a concentration of 4 mg/mL was used.
The chambers were then closed again and incubated for 90 minutes at 32 ± 1 °C.
After incubation, the content of the posterior chamber was thoroughly mixed. Then, its optical density at 492 nm was measured with the microtiter plate photometer.
SELECTION AND PREPARATION OF CORNEAS
- only corneas which were free from damages were used
- corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside.
NUMBER OF REPLICATES
- there replicates
NEGATIVE CONTROL USED
yes
POSITIVE CONTROL USED
yes
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes, 2 hours at 32 ± 1 °C
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD at 492nm)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
VALIDITY: The test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean. The mean IVIS of the negative control has to show an IVIS ≤ 3.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.39
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes: Hank’s Balanced Salt Solution (HBSS): no irritating effect on the cornea, IVIS (In Vitro Irritancy Score) = 1.34.
- Acceptance criteria met for positive control: yes: Dimethylformamide (DMF) undiluted: serious eye damage on the cornea, IVIS = 120.36 (within two standard deviations of the current historical mean)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol showed no effects on the cornea of the bovine eye. The calculated IVIS (In Vitro Irritancy Score) is 0.39. According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
- Executive summary:
The test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol was brought onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured. Bovine corneas used in this study were collected from slaughtered cattle that were between 12 and 60 months old.
The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured. One valid experiment was performed.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (In Vitro Irritancy Score) is 1.34.
Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS is 120.36.
Under the conditions of this study, the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4- methanol showed no effects on the cornea of the bovine eye. The calculated IVIS is 0.39.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
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