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EC number: 261-351-5 | CAS number: 58594-72-2
- 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 12, 1998-May 26, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Well documented study performed according to Product Safety Labs' Protocol P322. Acute Dermal Toxicity Limit Test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- Reported as Product Safety Labs Protocol P322. Acute Dermal Toxicity Limit Test
- GLP compliance:
- yes
- Remarks:
- The study meets the requiremenmts of 40 CFR Part 160 with the following exception: The stability, characterization, identity and verification of the test item concentration as received and tested are the responsibility of the study sponsor.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate
- EC Number:
- 261-351-5
- EC Name:
- 1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate
- Cas Number:
- 58594-72-2
- Molecular formula:
- C14H14Cl2N2O.H2O4S
- IUPAC Name:
- 1-[2-(2,4-DICHLOROPHENYL)-2-(PROP-2-EN-1-YLOXY)ETHYL]-1H-IMIDAZOLE SULFATE (1:1)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Product names: FUNGAFLOR® 75C / FUNGAFLOR® 75SP / FUNGAZIL® 750SP / FUNGAFLOR® 75PS / FUNGAZIL® 75SP / FUNGAFLOR® 750SP
- Reference number: JNJ-2634372-ABI / R027180 (product code)
- Physical state: solid
- Appearance: beige solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ZR027180PUE331/PSL Code Number E80511-2H
- Expiration date of the lot/batch: October 15, 2003
- Purity test date: Imazalil base (75%), inerts (25%)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: Expected to be stable for the duration of testing.
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in water (>500 g/L)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Prior to application, the test item was moistened to achieve a dry paste by preparing a 90% w/w mixture in distilled water.
- Final preparation of a solid: The sample was applied as a 90% w/w mixture in distilled water.
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: Young adult males and females
- Weight at study initiation: Males-2.3-2.6 kilograms; Females-2.2-2.5 kilograms
- Fasting period before study: no data
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which confirm to the size recommendations in the Guide for the Care and use of Laboratory Animals DHEW (NIH) No. 86.23. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by a automatic water dispensing system.
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-22.2 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- distilled
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area and trunk. On the day prior to application, a group of animals was prepared by clipping (Oster model #A2-small) the dorsal area and the trunk.
- % coverage: 4 in x 8 in area (approximately 10% of the body surface area)
- Type of wrap if used: The test material was applied to approximately to 4 in x 8 in area and covered with a 4 in x 8 in 6-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with a 3 inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test item. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were gently wiped with water and a clean towel to remove residual test material.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Constant volume or concentration used: yes
- For solids, paste formed: Yes, dry paste. - Duration of exposure:
- 24 h
- Doses:
- 1
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations-1 and 3 hours after application of test item and at least once daily thereafater for 14 days or until mortality. Weighing-Days: On day prior to application and then on days 7 and 14.
- Necropsy of survivors performed: yes: All surviving animals were euthanized via sodium pentobarbital on Day 14. A gross necropsy was performed on the decedent and all euthanized animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Dermal irritation (eschar and/or erythema and edema) were noted at the dose site of all animals between days 1 and 14.
- Mortality:
- One male (Male 4428) died within two days of test item application.
- Clinical signs:
- Male 4428: Toxic signs prior to death included irregular respiration, hypoactivity and prone posture.
With the exception of prone posture, the surviving rabbits exhibited similar clinical signs, as well as reduced food consumption and reduced fecal volume, but recovered by Day 8.
Dermal irritation (eschar and/or erythema and edema) was also noted at the dose site of all animals between Days 1 and 14. - Body weight:
- Several animals (Male 4426, Female 4429, Female 4431) exhibited a loss of bodyweights at 7 days, however, all Day 14 bodyweights exceeded those recorded at initiation.
- Gross pathology:
- The gross necropsy of the decedent revealed discoloration of the lungs and injected veins of the intestines. Gross necropsy findings at terminal sacrifice were unremarkable. No gross abnormalities were noted for the animals necropsied at the conclusion of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Single Dose Acute Dermal LD50 of the test item is greater than 2,000 mg/kg of bodyweight.
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