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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2018- November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An in vivo study was conducted because an experimental study according to OECD 442E was not applicable, and the results obtained from OECD 442D and OECD 442C studies were not conclusive for classification.
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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca Ola Hsd mice
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP ZRT. H-1103, Budapest, Cserkesz u. 90. Hungary
- Females: yes, nulliparous and non-pregnant
- Hygienic level at arrival: SPF
- Age at study initiation: 12 weeks old (at start of both Dose Range Finding tests-DRFs)
- Weight at study initiation: 19.4 – 21.5 g
- Diet (e.g. ad libitum): ad libitum, ssniff® Rat/Souris-Elevage E complete diet for rats and mice
- Water (e.g. ad libitum): ad libitum
- Acclimation period (Main Test): 7 days
- Acclimation period (DRF): 28 days prior to the first DRF, 21 days prior to the second DRF
- Indication of any skin lesions:
- Animal health: Only healthy animals (and not showing any sign of skin lesion) were used.
ENVIRONMENTAL CONDITIONS
Housing during acclimatization period: Grouped caging in small groups
Housing during the test: Grouped caging (4 animals/cage)
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 – 70 %
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The test item (formulated in AOO) was tested at four test concentrations (10 %, 5 %, 2.5 % and 1 % w/v).
- No. of animals per dose:
- 4 animals per dose (in total 24 animals*)
* Including control animals shared with the concurrent LLNAs. Number of shared animals: 8. - Details on study design:
- The pooled treatment group approach was used in this test.
The maximum dose selection was performed according to the relevant guidelines and based on results of a formulation evaluation and two consecutive Dose Range Finding tests (DRFs).
The liquid test item was adequately miscible in Acetone : Olive oil 4:1 (v/v) mixture (AOO) or N,N-Dimethylformamide (DMF) (standard vehicles which are most preferred in the LLNA). Formulations prepared with both vehicles were evaluated in the DRFs to find the most adequate vehicle and the highest applicable concentration. Symptoms of adverse effects were observed in both vehicles at high test concentrations (irritation in AOO, irritation and systemic toxicity in DMF) in the DRFs. Based on the results AOO was more adequate vehicle than DMF and the highest applicable non-toxic, non-irritant concentration was 10 % (w/v) in AOO. According to this the test item was examined in the main test as 10 %, 5 %, 2.5 % and 1 % (w/v) formulations in AOO.
Appropriate positive control (α-Hexylcinnamaldehyde, HCA) and a negative control group dosed with the vehicle of both the positive control and the test item (AOO) were employed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Significance of the dose-response was evaluated by linear regression using the calculated SI values. All calculations were made by Microsoft Excel Software.
Results and discussion
- Positive control results:
- - Visually larger lymph nodes compared to the vehicle control (AOO)
- No mortality, cutaneous reactions or signs of toxicity
- calculated SI value: 20.9.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 1%
- Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 10%
- Cellular proliferation data / Observations:
- Visually larger lymph nodes compared to the vehicle control (AOO) were observed in the positive control group and in the 10 % (w/v) dose group. Appearance of the lymph nodes was normal in the negative control group (AOO) and in the other test item treated groups (5 %, 2.5 % and 1 %, w/v). Significant lymphoproliferative response (SI ≥ 3) was observed for the test item at all tested concentrations.
The observed stimulation index values were 20.4, 12.0, 4.6 and 4.1 at test item concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v), respectively. Significance of the dose-response was evaluated by linear regression using the SI values. Significant dose-response correlation was observed (p = 0.01, r = 0.99).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol tested at the maximum feasible (non-toxic, non-irritant) concentration of 10% (w/v) and also at concentrations of 5 %, 2.5 % or 1 % (w/v) as formulations in a suitable vehicle (Acetone : Olive oil 4:1 (v/v) mixture, AOO) was shown to have skin sensitization potential in the Local Lymph Node Assay in mice.
- Executive summary:
The aim of this study was to determine the skin sensitization potential of 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol following dermal exposure in the Local Lymph Node Assay in mice. The pooled treatment group approach was used in this test.
The maximum dose selection was performed according to the relevant guidelines and based on results of a formulation evaluation and two consecutive Dose Range Finding tests (DRFs).
The liquid test item was adequately miscible in Acetone : Olive oil 4:1 (v/v) mixture (AOO) or N,N-Dimethylformamide (DMF). Formulations prepared with both vehicles were evaluated in the DRFs to find the most adequate vehicle and the highest applicable concentration. Symptoms of adverse effects were observed in both vehicles at high test concentrations (irritation in AOO, irritation and systemic toxicity in DMF) in the DRFs. Based on the results AOO was more adequate vehicle than DMF and the highest applicable non-toxic, non-irritant concentration was 10 % (w/v) in AOO. According to this the test item was examined in the main test as 10 %, 5 %, 2.5 % and 1 % (w/v) formulations in AOO.
Appropriate positive control (α-Hexylcinnamaldehyde, HCA) and a negative control group dosed with the vehicle of both the positive control and the test item (AOO) were employed.
The positive control item (25 % (w/v) HCA in AOO) induced significant stimulation over the relevant control (SI = 20.9). Thus, confirming the sensitivity and validity of the assay.
No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation (monitored by erythema scoring) or any other local effect were observed at the treatment site (ears) in any treatment group.
Significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the control was noted for 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol at the applied test concentrations. Significant dose-response correlation was observed. The observed stimulation index values were 20.4, 12.0, 4.6 and 4.1 at test item concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v), respectively. Significant dose-response correlation was observed (p = 0.01, r = 0.99, evaluated by linear regression using the SI values).
According to evaluation criteria of the relevant guidelines, the significantly increased lymphoproliferation (indicated by an SI ≥ 3) at the maximum feasible concentration of 10 % (w/v) and also at lower concentrations as well as the significant dose-response correlation are considered as evidence that 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol is a skin sensitizer.
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