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EC number: 229-604-4 | CAS number: 6628-04-2
- 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 irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 11 to June 22, 2015.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 430, EU Method B.40 and GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-amino-2-methylquinoline
- EC Number:
- 229-604-4
- EC Name:
- 4-amino-2-methylquinoline
- Cas Number:
- 6628-04-2
- Molecular formula:
- C10H10N2
- IUPAC Name:
- 4-amino-2-methylquinoline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 4-Aminoquinaldine.
- Chemical name: 4-amino-2-methylquinoline.
- Physical state: slightly yellow powder.
- Analytical purity: 98.1%
- Purity test date: April 13, 2015.
- Lot/batch No.: 83
- Expiration date of the lot/batch: April 2018.
- Storage condition of test material: 15-25ºC.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre for Experimental Medicine (Medical University in Katowice).
- Age at study initiation: 20 days old.
- Housing: Plastic cage covered with a wire bar lid, of 58 x 37 x 21 cm. UV-sterilised wood shavings were used as bedding.
- Diet (e.g. ad libitum): Murigran (batch number 3/15) standard granulated laboratory fodder ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 3 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 ºC.
- Humidity (%): 44-89 %.
- Air changes (per hr): about 16 times/hour.
- Photoperiod (hrs dark / hrs light): 12 hours/12h light.
Test system
- Type of coverage:
- other:
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- distilled water
- Controls:
- yes
- Amount / concentration applied:
- VEHICLE
- Amount(s) applied (volume or weight with unit): Distilled water (150 μL). - Duration of treatment / exposure:
- 24 h
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: The skin disc were removed from the dorsal and flank areas.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item and the control items were removed by washing with a jet of tap water at up to 30ºC.
- Time after start of exposure: 24h
SCORING SYSTEM:
The test item is considered to be non-corrosive to skin if:
- the mean TER value obtained for the test item is greater than 5 kΩ, or
- the mean TER value is less than or equal to 5 kΩ, and the skin disc shows no obvious damage.
The test item is considered to be corrosive to skin if:
- the mean TER value obtained for the test item is less than or equal to 5 kΩ and
- the skin disc is obviously damaged.
Results and discussion
In vivo
- Irritant / corrosive response data:
- The gross examination showed that the positive control skin discs exhibited skin perforation, whereas the negative control skin discs and the ones treated with the test item did not reveal any changes.
Any other information on results incl. tables
Table 1. Results of the transcutaneous electrical resistance test (TER).
Animal number |
Tested substance |
Skin disc number |
TER value(kΩ) |
Mean TER value± SD (kΩ) |
1 |
Positive control – 36 % HCl |
1 |
0.89 |
0.89 ± 0.01 |
2 |
0.90 |
|||
3 |
0.89 |
|||
Negative control – distilled water |
1 |
19.68 |
19.56 ± 0.27 |
|
2 |
19.25 |
|||
3 |
19.75 |
|||
Test item |
1 |
5.68 |
5.91 ± 0.29 |
|
2 |
5.81 |
|||
3 |
6.23 |
|||
2 |
Positive control – 36% HCl |
1 |
0.90 |
0.90 ± 0.01 |
2 |
0.91 |
|||
3 |
0.90 |
|||
Negative control – distilled water |
1 |
16.58 |
16.91 ± 0.31 |
|
2 |
17.20 |
|||
3 |
16.95 |
|||
Test item |
1 |
6.68 |
6.81 ± 0.18 |
|
2 |
6.73 |
|||
3 |
7.01 |
Table 2. Gross changes on the surface of the treated skin discs.
Animal number |
Tested substance |
Skin disc number |
Gross changes |
1 |
Positive control – 36% HCl |
1 |
Perforation |
2 |
Perforation |
||
3 |
Perforation |
||
Negative control – distilled water
|
1 |
No changes |
|
2 |
No changes |
||
3 |
No changes |
||
Test item
|
1 |
No changes |
|
2 |
No changes |
||
3 |
No changes |
||
2 |
Positive control – 36% HCl |
1 |
Perforation |
2 |
Perforation |
||
3 |
Perforation |
||
Negative control – distilled water
|
1 |
No changes |
|
2 |
No changes |
||
3 |
No changes |
||
Test item
|
1 |
No changes |
|
2 |
No changes |
||
3 |
No changes |
The gross examination showed that the positive control skin discs exhibited skin perforation, whereas the negative control skin discs and the ones treated with the test item did not reveal any changes.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item did not induce skin corrosion/severe irritation effects in this in vitro TER skin corrosion test.
- Executive summary:
The in vitro skin corrosion test (transcutaneous electrical resistance), was performed according to OECD Guideline 430, EU method B.40 and followed GLP principles. The skin discs used in the experiment were obtained from 2 young female Wistar rats (28 -day-old animals). The electrical resistance of the skin discs measured before the start of the experiment was greater 10 kΩ. Three skin discs obtained from each animal were used for the test item and three for each control item. The test item was applied to the epidermal surface of the skin placed in a tube for 24h. Positive (36% hydrochloric acid) and negative (distilled water) controls were conducted concurrently. After removing the test item (or control item), the surface tension of the skin was reduced with a solution of ethanol, and after that a solution of MgSO4 was applied to hydrate the skin. Then the electrical resistance of the skin was measured placing the databridge electrodes on either side of the skin disc. The mean TER results were 5.91 and 6.81 kΩ (both higher than 5 kΩ). After that, the MgSO4 solution was removed and gross examination of the skin did not detect visible changes. In conclusion, the test item was not considered to lead to skin corrosion/severe irritation under the test conditions.
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