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EC number: 625-810-7 | CAS number: 2927-71-1
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 July 2016 to 8 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,4-dichloro-5-fluoropyrimidine
- EC Number:
- 625-810-7
- Cas Number:
- 2927-71-1
- Molecular formula:
- C4HCl2FN2
- IUPAC Name:
- 2,4-dichloro-5-fluoropyrimidine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL- Lot/batch No.of test material: RZ2-H70762-064RADIOLABELLING INFORMATION- Radiochemical purity: not available- Specific activity: 81.8 Ci/mmolSTABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Room temperature, protected from light
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Outside vendor- Age at study initiation: 7 to 9 weeks- Weight at study initiation: 15 to 25 g - Housing: Solid bottom cages with bedding and automatic water supply- Diet (e.g. ad libitum): Standard certified commerical laboratory diet- Water (e.g. ad libitum): Municipal tap water- Acclimation period: 7 days- Indication of any skin lesions: All animals with any evidence of disease or physical abnormalities were not be selected for studyENVIRONMENTAL CONDITIONS- Temperature (°C): 20-26- Humidity (%): 30-70- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Phase 1 (Irritation Screen) - Test material was applied at concentrations of 1, 5, 10, 25, and 50% once daily on Days 1, 2, and 3 via dermal application.Phase 2 (main study) - Test material was applied at concentrations of 1, 5, 10 % once daily on Days 1, 2, and 3 via dermal application.
- No. of animals per dose:
- Phase 1 (Irritation Screen) - 2 animals per concentration of the the test materialPhase 2 (main study) - 5 animals per concentration of the the test material
- Details on study design:
- PRE-SCREEN TESTS: (Phase 1)- Compound solubility: Yes- Irritation: YesMAIN STUDY Observations for morbidity, mortality, injury, and the availability of food and water were conducted twice daily for all animals. Observations for clinical signs were conducted 2 to 4 hours postdose on days 1 through 3 and daily thereafter for all animals. Body weights were measured and recorded on Days 1 (prior to dosing) and 6 (prior to administration of the cell proliferation marker article for Phase 2 animals). Auricular lymph nodes were harvested approximately 5 hours post [3H]-Methyl Thymidine injection. Cell samples from the harvested lymph nodes were subsequently analyzed for total radioactivity by liquid scintillation counting (LSC) for 5 minutes or 100,000 counts. The raw data were expressed as disintegrations per minute (dpm) per animal and background values were determined.ANIMAL ASSIGNMENT AND TREATMENT- Name of test method: Nurine local lymph node assay- Criteria used to consider a positive response: To cause or elicit skin sensitisation reactions (allergic contact dermatitis)TREATMENT PREPARATION AND ADMINISTRATION: The prepared test material formulation was dispensed on each day of dosing and stored at room temperature. The vehicle, Acetone/Olive Oil (4:1, v:v), was prepared for use on each day of dosing. The test substance was mixed with the appropriate amount of vehicle to achieve concentrations of 1, 5, 10, 25, and 50%. A micropipette was used to apply 25 μL of the test formulation to the outer portion of the ear of the animal. On Day 6, the cell proliferation marker article, [3H]-Methyl Thymidine, was administered to the phase 2 animals via intravenous injection at a dose level of 20 μCi/animal and a dose volume of 0.25 mL/animal.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean and standard deviation were calculated for each endpoint by group. For each endpoint, treatment groups were compared to the reference groups using the following analysis: Body weight - Group Pair-wise Comparison (Levene’s/ANOVA-Dunnett’s/Welch’s) Distintegrations per Minute (DPM) - Log Transformation/Group Pair-wise Comparisons
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- Standard Deviation: 175.69 dpm
- Test group / Remarks:
- Vehicle
- Parameter:
- SI
- Value:
- ca. 13.55
- Variability:
- Standard Deviation: 1346.02 dpm
- Test group / Remarks:
- 35% HCA
- Parameter:
- SI
- Value:
- ca. 21.23
- Variability:
- Standard Deviation: 3490.69 dpm
- Test group / Remarks:
- Test Substance Concentration 1%
- Parameter:
- SI
- Value:
- ca. 51.09
- Variability:
- Standard Deviation: 11852.63 dpm
- Test group / Remarks:
- Test Substance Concentration 5%
- Parameter:
- SI
- Value:
- ca. 48.1
- Variability:
- Standard Deviation: 9867.88 dpm
- Test group / Remarks:
- Test Substance Concentration 10%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA The cell proliferation marker article, [3H]-Methyl Thymidine, was used as received from the supplier and no adjustments were made for purity. On the day of dosing, the radioactive cell marker was diluted with the appropriate volume of 1X Phosphate Buffered Saline (PBS) to achieve a radioactivity concentration of 80 μCi/mL. The solution was mixed thoroughly and stored at room temperature prior to dosing.DETAILS ON STIMULATION INDEX CALCULATIONIndividual lymph node radioanalysis values, expressed as disintegrations per minute (dpm) per animal were documented. The mean dpm for each group wascalculated, and the Sensitization Index (SI) was calculated as the ratio of the unbiased estimate of the mean of the treated group again the control group. An SI equal to or greater than 3.0 classified the test substance as a potential sensitiser.CLINICAL OBSERVATIONS:There were no significant findings or signs of local irritation and toxicity for animals administered vehicle or 1% test substance during the main study. 3 of 5 animals administered 5% of test mixture were observed with red discoloration of the skin (left and right ear), earliest onset of symptoms occurred on Day 2. All animals administered 10% Compound 2431768 were observed with red discoloration of the skin (left and right ear) in all animals, earliest onset of these symptoms was observed on Day 2 of the study. BODY WEIGHTSThere was no test article-related effect on body weight during the course of this study
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Compound 2431768 formulations (1, 5, and, 10%) resulted in an SI ≥3 relative to the vehicle control and therefore, were determined to be sensitisers at all of the tested concentrations in the Murine Local Lymph Node Assay. The positive control resulted in an SI ≥3, confirming the integrity of the assay.
- Executive summary:
Skin sensitisation potential of LSN24314768 was investigated using the murine local lymph node assay. Dose response information was used to assign skin sensitisation hazard sub-categories according to UN GHS and EU CLP classification criteria.
The positive control group (35% HCA) resulted in a sensitization index (SI) of 13.55 relative to the vehicle, which is ≥3 confirming the integirty of the assay.
When the 1, 5, and, 10% Compound 2431768 formulations were compared to the vehicle group, the sensitisation indices were 21.23, 51.09, and 48.10, respectively.
Compound 2431768 formulations (1, 5, and, 10%) resulted in an SI ≥3 relative to the vehicle control and therefore, were determined to be sensitisers at all of the tested concentrations in the Murine Local Lymph Node Assay.
Since the estimated concentration of LSN2431768 needed to produce a SI of 3 is <1% i.e. the EC3 is ≤2% this compound will be classified as a skin sensitiser sub-category 1A.
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