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EC number: 205-003-2 | CAS number: 130-95-0
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was done according to OECD guideline 437.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Principles of method if other than guideline:
- Test System: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 Hank’s balanced salt solution (supplemented with 0.01 % streptomycin and 0.01 % penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 hour. Preparations:After having carefully cleaned and sterilised the cornea holders, they were kept in the incubation chamber at 32 °C. On the day of the assay, the MEM without phenol red was supplemented with sodium bicarbonate, L-glutamine and 1 % fetal calf serum (= complete MEM) and stored in a water bath at 32 °C ± 1 °C. The same was performed with the MEM with phenol red. After the arrival of the corneas they were examined and only corneas which were free from defects 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 without phenol red was filled. The holders were then incubated for one hour in the incubation chamber at 32 °C.Method Description:After the initial incubation, the medium was changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used. The baseline opacity was measured by placing the holder with the cornea in a spectral photometer and recording the absorption at 570 nm. Opacity is calculated from the measured absorption. For each treatment group (negative control solution, test item suspension and positive control solution), three replicates were used. After removal of the pre-incubation medium, 750 μL negative control solution resp. test item suspension resp. positive control solution were applied to each replicateAccording to the characteristics of the test item, the following treatment procedure was performed: Open Chamber Method:The “open chamber-method” is used for solid substances. In order to apply the test item, the nut was unscrewed to remove the glass disc. The test item could be applied directly on the cornea now. 750 μL of the test item were tested as suspension at 20 % concentration in 0.9 % sodium chloride solution. The test item suspension was given on the epithelium in such a manner that as much as possible of the cornea was covered with test item suspension. Exposition time on the corneas was 4 h ± 5 min. at 32 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, both chambers were filled with cMEM without phenol red, and the final opacity value of each cornea was recorded at once (again by measurement at 570 nm). The cMEM without phenol red was then removed from the front chamber, and 1 mL sodium fluorescein solution (concentration5 mg/mL) was added to the front chamber. The chambers were then closed again and incubated for 90 ± 5 min at 32 ± 1 °C. After incubation, the content of the posterior chamber was thoroughly mixed. Then, the permeability of the cornea was measured as optical density of the liquid at 490 nm.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Quinine Base Anhydrous
- IUPAC Name:
- Quinine Base Anhydrous
- Reference substance name:
- Quinine
- EC Number:
- 205-003-2
- EC Name:
- Quinine
- Cas Number:
- 130-95-0
- Molecular formula:
- C20H24N2O2
- IUPAC Name:
- quinine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Quinine Base Anhydrous
- Molecular formula (if other than submission substance): C20H24N2O2
- Molecular weight (if other than submission substance): 324.43 g/mol
- Substance type: white powder
- Physical state: solid
- Analytical purity:98.6% Quinine,
- Impurities (identity and concentrations): 1.3% Dihydroquinine, 0.1% Other alkaloids (HPLC)
- Composition of test material, percentage of components: 100.0 % Alkaloid base (Titration)
- Lot/batch No.: Lot 7974
- Stability under test conditions: H2O; EtOH; acetone: 96h; CH3CN; DMSO: unknown
- Storage condition of test material: does not require any special temperature storage conditions, keep away from light and humidity
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: Bos primigenius Taurus (Fresh bovine corneas)
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.9 % sodium chloride solution
- Amount / concentration applied:
- TEST MATERIAL- Concentration (if solution): 20% in 0.9 % sodium chloride solution
- Duration of treatment / exposure:
- Incubation time: 4 hours at 32 ± 1 °C
- Details on study design:
- Negative Control: Sodium chloride solution: 0.9 % NaCl (CAS-No. 7647-14-5), dissolved in demin. water.Positive Control: Imidazole solution: 20 % C3H4N2 (CAS-No. 288-32-4), dissolved in 0.9 % NaCl.The test item is a non-surfactant solid substance. It was tested as a suspension at a concentration of 20 % in 0.9 % sodium chloride solution.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 18.15
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Mean of 3 experiments. Standard deviation: 11.4 %
Any other information on results incl. tables
Opacity and Permeability Values
The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:
A) Absorption and Opacity Values Negative Control:
Parameter | Negative Control | ||
Absorption before exposition | 0.1534 | 0.1456 | 0.1523 |
Absorption after exposition | 0.2548 | 0.1948 | 0.2557 |
Opacity before exposition | 1.4236 | 1.3983 | 1.4200 |
Opacity after exposition | 1.7980 | 1.5660 | 1.8018 |
Opacity Difference | 0.3744 | 0.1677 | 0.3817 |
Mean opacity difference of the negative control is 0.3080.
B) Absorption and Opacity Values Test Item and Positive Control:
Parameter | Test Item Quinine Base Anhydrous | Positive Control | ||||
Absorption before exposition | 0.1916 | 0.2158 | 0.1423 | 0.1539 | 0.1389 | 0.1598 |
Absorption after exposition | 0.6452 | 0.5839 | 0.5777 | 1.5211 | 1.7040 | 1.5634 |
Opacity before exposition | 1.5545 | 1.6436 | 1.3877 | 1.4253 | 1.3769 | 1.4448 |
Opacity after exposition | 4.4177 | 3.8362 | 3.7818 | 33.1971 | 50.5825 | 36.5932 |
Opacity Difference | 2.8632 | 2.1926 | 2.3941 | 31.7718 | 49.2056 | 35.1484 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
C) Optical density at 490 nm:
Repl. | Negative Control | Test Item Quinine Base Anhydrous | Positive Control | ||||||
Meas. | 0.0074 | 0.0059 | 0.0099 | 0.2255 | 0.2459 | 0.1908 | 0.5096 | 0.3197 | 0.3642 |
Corr. | 0.0370 | 0.0295 | 0.0495 | 1.1275 | 1.2295 | 0.9540 | 2.5480 | 1.5985 | 1.8210 |
Mean | 0.0387 | -- |
Note: In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS.
IVIS Values
IVIS was calculated using the values in tables A, B and C and the equation IVIS = (opacity difference – mean opacity difference of the negative controls) + [15 * (corr.OD490 – mean corr. OD490 of the negative controls)]
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
D) IVIS:
Test Group | IVIS | Mean IVIS | Relative Standard Deviation IVIS |
Negative Control 0.9% NaCl | 0.929 | ||
0.610 | 0.888 | 29.2 % | |
1.124 | |||
Test Item Quinine Base Anhydrous | 18.887 | ||
19.747 | 18.150 | 11.4 % | |
15.816 | |||
Positive Control 20% imidazole | 69.103 | ||
72.295 | 67.658 | 8.1 % | |
61.575 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN GHS
- Conclusions:
- According to the study report, quinine base anhydrous showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 18.15. Therefore, quinine base anhydrous is mildly irritating to eyes.
- Executive summary:
This in vitro study was performed to assess serious eye damage of quinine base anhydrous by quantitative measurements of changes in opacity and permeability in a bovine cornea. Two experiments were performed. The first experiment was cancelled, because the value of the positive control was not within the range of the historical data. The second experiment was valid. The test item quinine base anhydrous was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been determined. A 20% quinine base anhydrous solution was incubated on the cornea for four hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control and imidazole (20 % solution in 0.9 % sodium chloride solution) was used as positive control. The negative control showed no irritation effects and no serious eye damage, mean IVIS was 0.888. The positive control induced serious eye damage on the cornea, mean IVIS was 67.658. Under this test condition, quinine base anhydrous showed effects on the cornea of the bovine eye. A mean IVIS of 18.150 was calculated.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in a UN GHS Category. But according to the Background Review Document Current Status of In Vitro Test Methods for Identifying Mild/Moderate Ocular Irritants: Bovine Corneal Opacity and Permeability Test Method, 2010 a substance with an IVIS of 3.1 - 25 is mild irritant. Therefore, we assumed that quinine base anhydrous is mildly irritating to eyes.
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