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EC number: 277-531-1 | CAS number: 73545-11-6
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 08 October 2018 and 11 October 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:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B40-BIS
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection: 15 and 16 November 2017; Date of Signature on Certificate: 15 May 2018
Test material
- Reference substance name:
- 7-(4-ethyl-1-methyloctyl)quinolin-8-ol
- EC Number:
- 277-531-1
- EC Name:
- 7-(4-ethyl-1-methyloctyl)quinolin-8-ol
- Cas Number:
- 73545-11-6
- Molecular formula:
- C20H29NO
- IUPAC Name:
- 7-(5-ethylnonan-2-yl)quinolin-8-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1702-18-01/O
- Expiration date of the lot/batch: 25 March 2021
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Storage at room temperature (20 ± 5 °C); keep away from light.
In vitro test system
- Test system:
- human skin model
- Source species:
- other: reconstituted human epidermis
- Cell type:
- other: reconstituted human epidermis
- Cell source:
- other: reconstitued human epidermis
- Source strain:
- other: N/A
- Details on animal used as source of test system:
- N/A - reconstitued human epidermis
- Justification for test system used:
- The test system has been validated as acceptable for this purpose
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: One
- Observable damage in the tissue due to washing: None reported
- Modifications to validated SOP: N/A
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Anthos Reader 2010 Flexi
- Wavelength: 570 nm
- Filter: N/A
- Filter bandwidth: N/A
- Linear OD range of spectrophotometer: Not reported
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE N/A
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
Two
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Pass (2.027 +/- 0.095)
- Barrier function: Pass (5.11 hours)
- Contamination: Pass (Sterile)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): N/A
VEHICLE
N/A
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): N/A
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8M - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 - 3 min incubation
- Value:
- 102.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 2 - 1 hour incubation
- Value:
- 102.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Demonstrated. The twelve proficiency substances were correctly classified.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: N/A
Any other information on results incl. tables
Measured Values
As blank, the optical density of isopropanol was measured in 12 wells of the 96-well-plate. The measured values and their mean are given in the following table:
Absorbance values blank isopropanol (OD 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
Mean 0.038 |
Absorbance |
0.040 |
0.039 |
0.039 |
0.039 |
0.038 |
0.038 |
|
Replicate |
7 |
8 |
9 |
10 |
11 |
12 |
|
Absorbance |
0.040 |
0.038 |
0.037 |
0.038 |
0.038 |
0.037 |
The absorbance values of negative control, test item and positive control are given in the following table:
Absorbance Values (OD 570 nm)
Incubation |
Negative Control |
Test Item |
Positive Control |
|||
|
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
3 min |
1.682 |
1.738 |
1.709 |
1.781 |
0.415 |
0.439 |
1.691 |
1.684 |
1.715 |
1.748 |
0.411 |
0.439 |
|
1.688 |
1.677 |
1.709 |
1.733 |
0.413 |
0.438 |
|
1 h |
1.578 |
1.570 |
1.658 |
1.555 |
0.250 |
0.258 |
1.546 |
1.563 |
1.630 |
1.539 |
0.250 |
0.257 |
|
1.541 |
1.557 |
1.630 |
1.536 |
0.249 |
0.258 |
From the measured absorbances, the mean absorbance of isopropanol (given in table 8.1-a) was subtracted. The corrected mean and relative standard deviation (RSD) of the two tissues were also calculated.
Mean Absorbance Values of the 3 Minutes Experiment
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.649 |
1.673 |
0.375 |
Mean – blank (tissue 2) |
1.661 |
1.716 |
0.400 |
Mean of the two tissues |
1.655 |
1.694 |
0.387 |
RSD |
0.5% |
1.8% |
4.7% |
Mean Absorbance Values of the 1 h Experiment
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.517 |
1.601 |
0.211 |
Mean – blank (tissue 2) |
1.525 |
1.505 |
0.219 |
Mean of the two tissues |
1.521 |
1.553 |
0.215 |
RSD |
0.4% |
4.4% |
2.6% |
Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of mean tissue viability were calculated in comparison to the mean of the negative controls:
% Tissue Viability
Test Item |
Positive Control |
Incubation |
102.4% |
23.4% |
3 min |
102.1% |
14.2% |
1 h |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is considered non-corrosive to skin.
After 3 minutes treatment, the mean value of relative tissue viability of the test item was 102.4%. This value is well above the threshold for corrosivity (50%). After 1 hour treatment the mean value of relative tissue viability of the test item was 102.1%. This value is well above the threshold for corrosivity (15%).
The values of the negative control met the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals, thus showing the quality of the tissues.
The positive control has met the validity criterion too, thus ensuring the validity of the test system.
For these reasons, the result of the test is considered valid. - Executive summary:
One valid experiment was performed.
Two tissues of the human skin model EpiDermTMwere treated with the test itemfor 3 minutes and 1 hour, respectively. The test item was applied to each tissue and spread to match the tissue size.
Demineralised water was used as negative control, 8 M KOH was used as positive control.
After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan. Formazan production was evaluated by measuring the optical density (OD) of the resulting solution.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals thus showing the quality of the tissues. The OD was 1.7 (3 minutes experiment) and 1.5 (1 hour experiment).
The positive control showed clear corrosive effects for both treatment intervals. The mean relative tissue viability value was reduced to 14.2% for the 1 hour treatment.
After 3 minutes treatment with the test item, the mean value of relative tissue viability was increased to 102.4%. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, mean value of relative tissue viability was increased to 102.1%. This value, too, is above the threshold for corrosion potential (15%).
Therefore, the test item7-(4-ethyl-1-methyloctyl)quinolin-8-olis considered non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method.
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