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EC number: 695-745-7 | CAS number: 1079221-49-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 05 December 2013 to 21 February 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: in-vitro study, performed according to internationally recognised guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-({3-aminopyrazolo[1,5-a]pyridin-2-yl}oxy)ethan-1-ol hydrochloride
- EC Number:
- 695-745-7
- Cas Number:
- 1079221-49-0
- Molecular formula:
- C9 H11 N3 O2, ClH
- IUPAC Name:
- 2-({3-aminopyrazolo[1,5-a]pyridin-2-yl}oxy)ethan-1-ol hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis model
Test system
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 hours
- Details on study design:
- TEST SYSTEM:
- Reconstructed human epidermis model Episkin small model (0.38 cm²) supplied by SkinEthic Laboratories, Lyon, France.
- Episkin kits were maintained in agar medium for transportation. They were delivered at day 13 and used at days 15 to 17.
- The test item was also tested on dead epidermis because of its interaction with MTT.
PROTOCOL:
- After preliminary tests (dilutions and staining tests), the colored test item was tested according to the specific coloring protocol.
- Application of the test substance: 5 µL of distilled water were first applied onto the tissues in order to moister the surface. 10 mg of the test material were then applied onto the epidermis (dead and alive).
- treatment and post-incubation: after 15 minutes treatment period at room temperature, tissues were rinsed with PBS+ and transferred on 2 mL/well of fresh maintenance medium and incubated for 42 hours at 37°C.
- Number of replicates: 3
- Negative control: 10 µL of PBS+
- Positive control: 10 µL of 50 mg/mL aqueous solution of Sodium Dodecyl Sulfate
MEASURED PARAMETERS:
- Cell viability measurement: MTT test. The tissue sample was placed in MTT solution (0.3 mg/mL) for 3 hours. The MTT is converted into blue formazan by the viable cells. The precipitated blue formazan product was then extracted from the tissue using acidic isopropanol as solvent, and the concentration of formazan was measured by determining the optical density (OD) at 570 nm.
- Determination of the IL-1α concentration in the culture medium (by a classic quantitative sandwich enzyme immunoassay technique).
ACCEPTANCE CRITERIA:
The OD of the negative control should be ≥0.600 and its standard deviation should be ≤18%.
The viability of the positive control should be <40% with regard to the negative control and the standard deviation should be ≤18%.
The OD raw material NSC on living epidermis should be ≤30% of the OD negative control.
The corrected OD of the product under test on dead epidermis should be ≤30% of the corrected OD of the living negative control.
The correlation coefficient of the calibration curve for IL-1α should be ≥0.99.
The IL-1α concentration of the negative control should be < 50 pg/mL.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: % viability
- Value:
- 67.4
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 45 hours. Remarks: % SD = 17.6. (migrated information)
- Irritation / corrosion parameter:
- other: other: IL-1α (pg/mL)
- Value:
- 21.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 hours. Remarks: % SD = 14.4. (migrated information)
In vivo
- Irritant / corrosive response data:
- As Mean viability value is < 50% and IL-1α is < 50 pg/mL, the test item is considered as potentially non irritant
Any other information on results incl. tables
Result summary: % viability and IL-1αconcentrations
Raw material |
Run 1 |
Run 2 |
Run 3 |
Run 4 |
Mean |
SD |
Test item (undiluted) |
% viability |
|||||
51.6 |
85.3 |
53.0 |
79.7 |
67.4 |
17.6 |
|
IL-1α (pg/mL) |
||||||
42.7 |
10.6 |
16.6 |
16.0 |
21.5 |
14.4 |
This product presents results with a high variability due to the physical form of the raw material.
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- Depending on the experimental conditions used, the in vitro evaluation of acute skin irritation by using the reconstructed human epidermis Episkin(SM) model, suggests that the test item tested undiluted is considered as potentially non irritant.
- Executive summary:
In vitro evaluation of skin irritation was performed on the reconstructed human epidermis model Episkin small model (0.38cm²), with a method equivalent to OECD guideline 439 (GLP study, scored as validity 2 according to Klimisch criteria). The colored raw material was tested according to the specific coloring protocol. The test substance was qualified on 4 batches of reconstructed epidermis model and it was also tested on dead epidermis because of its interaction with MTT.
The tests item was tested undiluted. Negative and positive controls were tested in triplicate. The duration of treatement was 15 minutes, followed by an incubation period of 42h at 37°C. MTT test and determination of IL-1αconcentration were performed.
The mean of percentage of viability was 67.4% ± 17.6 and the mean of IL-1αconcentration 21.5 ± 14.4.
Depending on the experimental conditions used, the in vitro evaluation of acute skin irritation by using the reconstructed human epidermis Episkin(SM) model, suggests that the test item tested undiluted is considered as potentially non irritant.
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