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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 26 September 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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: Sponsor/1702-18-01/O
- Expiration date of the lot/batch: 25 Mar 2021
- Purity test date: 26 Mar 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (20 ± 5 °C); Keep away from light
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Stable
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
- Number of animals: not specified.
- Characteristics of donor animals (e.g. age, sex, weight): The cattle were between 12 and 60 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): 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 and 15 minutes.
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 - Duration of treatment / exposure:
- incubation time: 10 min
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3 replicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: Only corneas which were free from damage were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C.
QUALITY CHECK OF THE ISOLATED CORNEAS : After the initial incubation, the medium was completely changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : HBSS
POSITIVE CONTROL USED : Dimethylformamide (undiluted)
APPLICATION DOSE AND EXPOSURE TIME : 750 µL, EXPOSURE TIME 10 MINUTES.
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes. If YES please specify duration : 2 hours.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: the anterior chamber was rinsed with cMEM with phenol red, then with cMEM without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD 492 nm)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The IVIS of each replicate of the negative control was calculated from the following equation:
IVIS = opacity difference + (15 x corrected OD492 value)
The IVIS of each replicate of the positive control and of the test item were calculated from the following equation:
IVIS = (opacity difference – mean opacity difference of the negative control) + [15 x (OD492 – mean OD492 of the negative control)]
DECISION CRITERIA: OECD TG.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 0.21
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2
- Value:
- -1.44
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 0.75
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- -0.16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Values Negative Control
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.84 |
2.75 |
3.57 |
Opacity after exposure |
5.49 |
5.88 |
4.88 |
Opacity Difference |
2.66 |
3.13 |
1.31 |
Mean Opacity Difference |
2.36 |
Rep. = Replicate
Opacity Values Test Item and Positive Control
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.54 |
3.53 |
1.49 |
2.01 |
2.54 |
1.33 |
Opacity |
5.16 |
4.42 |
4.69 |
99.76 |
97.95 |
96.62 |
Opacity |
2.62 |
0.89 |
3.21 |
97.76 |
95.41 |
95.29 |
Opacity corrected |
0.25 |
-1.47 |
0.85 |
95.39 |
93.04 |
92.93 |
Mean Opacity corrected |
-0.12 |
93.79 |
Rep. = Replicate
Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1. Measurement |
0.050 |
0.045 |
0.065 |
0.048 |
0.053 |
0.049 |
0.950 |
1.392 |
1.931 |
2. Measurement |
0.051 |
0.043 |
0.056 |
0.047 |
0.053 |
0.043 |
0.962 |
1.388 |
1.998 |
3. Measurement |
0.048 |
0.043 |
0.057 |
0.048 |
0.052 |
0.041 |
0.952 |
1.394 |
1.953 |
|
|||||||||
1. Measurement – blank |
0.0070 |
0.0020 |
0.0220 |
0.0050 |
0.0100 |
0.0060 |
0.9070 |
1.3490 |
1.8880 |
2. Measurement – blank |
0.0080 |
0.0000 |
0.0130 |
0.0040 |
0.0100 |
0.0000 |
0.9190 |
1.3450 |
1.9550 |
3. Measurement – blank |
0.0050 |
0.0000 |
0.0140 |
0.0050 |
0.0090 |
-0.0020 |
0.9090 |
1.3510 |
1.9100 |
Mean of each replicate |
0.0067 |
0.0007 |
0.0163 |
0.0047 |
0.0097 |
0.0013 |
0.9117 |
1.3483 |
1.9177 |
Mean of the 3 replicates |
0.0079 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
-0.0032 |
0.0018 |
-0.0066 |
0.9038 |
1.3404 |
1.9098 |
Corrected mean of the 3 replicates |
-- |
-0.0027 |
1.3847 |
IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
2.76 |
2.48 |
33.25% |
3.14 |
|||
1.55 |
|||
Test Item |
0.21 |
-0.16 |
697.17% |
-1.44 |
|||
0.75 |
|||
Positive Control |
108.95 |
114.56 |
5.61% |
113.15 |
|||
121.58 |
Note: the high relative standard deviation of the IVIS of test item is due to mathematical reasons, as the respective means are very small
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 7-(4-ethyl-1-methyloctyl)quinolin-8-ol showed no effects on the cornea of the bovine eye. The calculated mean IVIS (In Vitro Irritancy Score) was -0.16.
The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item. - Executive summary:
Findings and Results:
One valid experiment was performed.
Bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old. The test item 7-(4-ethyl-1-methyloctyl)quinolin-8-ol was applied 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.
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.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irritancy Score) was 2.48.
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 mean IVIS was 114.56.
Under the conditions of this study, the test item 7-(4-ethyl-1-methyloctyl)quinolin-8-ol showed no effects on the cornea of the bovine eye. The calculated mean IVIS was -0.16.
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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