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EC number: 952-948-8 | CAS number: -
- 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
- Study period:
- 29 January 2020 to 20 May 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-bromo-1-(3-chloropyrid-2-yl)-5-methyl-1H-pyrazole
- Molecular formula:
- C9H7BrClN3
- IUPAC Name:
- 3-bromo-1-(3-chloropyrid-2-yl)-5-methyl-1H-pyrazole
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch/Lot Number: 628-044-00
Analysed Concentration: 974.9 ± 3.3 g/kg
Physical State: Beige Solid
Date of Manufacture: 15 October 2019
Date of Expiry: 15 October 2021
Constituent 1
- Specific details on test material used for the study:
- Storage Condition (at JRF):
Storage Temperature: Room temperature (15 to 30 °C).
Storage Condition: Cool and dry conditions.
Storage Container: In original container as supplied by the Sponsor.
Storage Location: Test Item Control Office, JRF.
Test animals / tissue source
- Species:
- human
- Strain:
- other: Reconstructed human cornea epithelium (RhCE)
- Details on test animals or tissues and environmental conditions:
- Test System: Reconstructed human cornea epithelium (RhCE).
Model: SkinEthicTM HCE.
Source: EPISKIN– 4 Rue Alexander Fleming, 69366 Lyon Cedex 07 – France.
Lot No.: 20-HCE-012.
Test system
- Vehicle:
- other: Dubelcco’s Phosphate Buffer Saline (DPBS)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 30 μL DPBS + 30 mg 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole.
NEGATIVE CONTROL:
Name: Dubelcco’s Phosphate Buffer Saline (DPBS).
- Amounts applied: 30 μL DPBS.
Batch Nº: 1918956.
Expiry Date: September 30, 2020.
Manufactured by: Gibco.
POSITIVE CONTROL:
Reference Substance Name: Methyl acetate.
- Amounts applied: 10 μL DPBS + 30 μL methyl acetate (undiluted).
CAS No: 79-20-9.
Analysed Purity: 99.5% .
Batch No: STBG5814V.
Supplied by: Sigma.
Manufactured by: Sigma.
Date of Receipt: May 08, 2017.
Date of Expiry : May 07, 2022.
Physical Appearance: Colourless liquid.
Storage Condition (at JRF): Room temperature. - Duration of treatment / exposure:
- Tissues were exposed to test item, negative and positive control for 4 h.
- Duration of post- treatment incubation (in vitro):
- For post incubation, the MTT test was performed. Tissues were placed in MTT (1.0 mg/mL) solution and incubated for 180 minutes at 37 ± 2°C in 5 ± 1% CO2 and saturated with humidity.
- Number of animals or in vitro replicates:
- Two replicates in each group (test item, positive control, negative control).
- Details on study design:
- NEGATIVE CONTROL USED: Yes.
- Name: Dubelcco’s Phosphate Buffer Saline.
- Batch Nº: 1918956.
POSITIVE CONTROL USED: Yes.
- Reference Substance Name: Methyl acetate.
- Analysed Purity: 99.5%.
- Batch No: STBG5814V.
NUMBER OF REPLICATES , APPLICATION DOSE AND EXPOSURE TIME
- Test material: 30 mg 3-Bromo-1-(3-Chloro-2-Pyridyl)-5-Methyl-1H-Pyrazole + 30 μL DPBS.
- Positive control: 10 μL DPBS + 30 μL methyl acetate (undiluted).
- Negative control: 30 μL DPBS.
- two replicates in each group (test item, positive/negative control).
Results and discussion
In vitro
Results
- Irritation parameter:
- other: optical density
- Run / experiment:
- Mean Percent Viability
- Value:
- 32.33
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- According OECD 492 "No prediction can be made".
- Other effects / acceptance of results:
- Validity of the Test:
- Negative control OD values were found to be within the range of > 1.0 to ≤ 2.5.
- Mean tissue viability values for positive control was found < 20%.
- Variation within the replicates was acceptable (< 20%).
Therefore, the experiment is considered valid.
Any other information on results incl. tables
Pre-Tests
Direct MTT Reduction Test
The test item did not produce direct MTT reduction when compared with that of the concurrent negative control (distilled water). Results of direct MTT reduction test are summarised in the table mentioned below:
Treatment |
Interaction |
Negative Control (distilled water) |
No |
3-Bromo-1-(3-Chloro-2-Pyridyl)-5-Methyl-1HPyrazole |
No |
Colour Interference Test
Any difference in the absorbance, due to colour interference, was not observed visibly for the test item. Results of direct MTT reduction test are summarised in the table mentioned below:
Treatment |
Interaction |
3-Bromo-1-(3-Chloro-2-Pyridyl)-5-Methyl-1HPyrazole |
No |
Negative Control
The individual optical density, corrected optical density, mean of corrected optical density, viability, and mean percent viability, are summarised in the following table.
The OD values (corrected mean ODs) of the negative control was 1.678 and 1.751. Therefore, results of the negative control met the acceptance range of the OECD test guideline 492 for the prediction model SkinEthicTM HCE. Test guideline requirement of optical density is > 1.0 and ≤ 2.5 (the acceptance criteria for SkinEthicTM HCE model, as per the OECD TG 492). Variation between the two negative controls tissues was < 20%, which met the acceptance range of the OECD test guideline 492 for the prediction model SkinEthicTM HCE. As per the certificate of analysis for the batch of tissues used in the study (Batch# 20-HCE-012), average optical density observed was 2.0 in QC testing at SkinEthic Laboratories. Therefore, the observed results were within the acceptable range of the SkinEthic Laboratories/OECD TG acceptance criteria.
Positive Control
The individual optical density, corrected optical density, mean of corrected optical density, viability, and mean percent viability, are summarised in the following table.
The mean % viability of the positive control was 18.51%, which met the acceptance criteria of the OECD test guideline 492, i.e., <20% viability.
Main Study
The individual optical density, corrected optical density, mean of corrected optical density, viability and mean per cent viability for test item are summarised in the following table.
The mean per cent viability of the 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole treated tissues, and the control tissues, is tabulated below:
Treatment |
Mean Percent Viability |
Negative control (DPBS) |
100.00 |
Positive control (methyl acetate) |
18.51 |
3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole |
32.33 |
The mean per cent cell viability in tissues treated with 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole was found to be 32.33% in the concurrent negative control (100%) which is below the established tissue viability cut-off value of 50%.
Therefore, based on these results, 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole is according OECD 492 assessed as “No prediction can be made”.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the mean viability score of 32.33%, determined under the specified experimental conditions using SkinEthicTM HCE RhCE, the classification for 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1Hpyrazole is “No prediction can be made” (UN GHS) and that further testing may be required in order to classify and/or determine if the test item is an ocular irritant. In accordance with the provisions of regulation 1272/2008 a prediction of classification can not be made.
- Executive summary:
Study type: Reconstructed Human Cornea-like Epithelium (RhCE) Test, OECD 492.
Study title: In Vitro Eye Irritation Test of 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole Using Reconstructed Human Cornea-Like Epithelium.
This study was performed to evaluate the ocular irritation potential of 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole, as measured by the potential to induce cytotoxicity in a reconstructed human cornea-like epithelium (RhCE) tissue construct which closely mimics the properties of the human corneal epithelium. The RhCE test can identify test items not requiring classification, according to the UN GHS (No category).
RhCE tissues (two tissues per set) were treated with 30 μL of either Dulbecco’s Phosphate Buffered Saline (DPBS) (Set 1 - control), 30 μL of undiluted methyl acetate (Set 2 - positive control), and 30 μL of Dulbecco’s Phosphate Buffered Saline (DPBS) along with 30 mg 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole (Set 3 – test group). The tissues were incubated for 4 h ± 6 minutes. At the end of the exposure period, residue was removed, and the tissue were kept for 30 minutes in the maintenance medium at room temperature, followed by an incubation period of 18 h ± 30 minutes.
Tissue viability was measured, following the treatment and a post-treatment incubation period, by enzymatic conversion of the vital dye MTT into a blue MTT formazan salt, measured after extraction from tissues. The optical density (OD) of the extracted formazan was determined using a microplate reader at 570 nm. The viability of the RhCE tissue was determined in comparison to tissues treated with the negative control substance (% viability) and was then used to predict the ocular hazard potential of the test chemical.
The mean per cent cell viability in tissues is shown below. The mean per cent cell viability in tissues treated with 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole was found to be 32.33% of the concurrent negative control (100%) which is below the established tissue viability cut-off value of 50%.
Treatment
Mean Percent Viability
Negative control (Dulbecco’s Phosphate Buffered Saline)
100.00
Positive control (methyl acetate)
18.51
3-Bromo-1-(3-Chloro-2-Pyridyl)-5-Methyl-1H-Pyrazole
32.33
The negative and positive controls met the acceptance criteria, as described in the study plan, and confirmed the reliability of the test procedure.
Based on the mean viability score of 32.33%, determined under the specified experimental conditions using reconstructed human cornea-like epithelium (RhCE) from EPISKIN, the classification for 3-bromo-1-(3-chloro-2-pyridyl)-5-methyl-1H-pyrazole is “No prediction can be made” (UN GHS) and that further testing may be required in order to classify the test item.
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