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EC number: 410-400-0 | CAS number: 88671-89-0 SYSTHANE TECHNICAL
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24-June-2005 to 29-September-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile
- EC Number:
- 410-400-0
- EC Name:
- α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile
- Cas Number:
- 88671-89-0
- Molecular formula:
- C15H17ClN4
- IUPAC Name:
- 2-(4-chlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]hexanenitrile
- Test material form:
- solid: crystalline
- Remarks:
- Light orange
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult (9-10 weeks)
- Weight at study initiation: 112-127 grams
- Fasting period before study: yes, Overnight
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Purina Certified Rodent Diet, ad libitum (except o/n before dosing)
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system
- Acclimation period: 6-16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22ºC
- Humidity (%): 66-70%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1.5% w/w solution in distilled water
- Details on oral exposure:
- An initial limit dose of 5,000 mg/kg was administered to one healthy female rat by oral gavage. Due to mortality in this animal, the study proceeded to the Main Test. Using the default starting level of 175 mg/kg bw and following the Up and Down procedure, eight additional females were dosed at levels of 550, 1,750, or 5,000 mg/kg bw.
- Doses:
- 175 mg/kg bw, 550 mg/kg bw, 1,750 mg/kg bw and 5,000 mg/kg bw.
- No. of animals per sex per dose:
- 175 mg/kg bw (1 animal), 550 mg/kg bw (1 animal), 1,750 mg/kg bw (3 animals) and 5,000 mg/kg bw (4 animals)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality, signs of gross toxicity, and behavioral changes for the first several hours post-dosing and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: The external surface of the body and all orifices, tissues, and organs of the thoracic and abdominal cavities were examined. - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was
used for all data analyses including: dose progression selections, stopping criteria determinations
and/or LD50 and confidence limit calculations.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 750 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals that were administered 5,000 mg/kg bw dose level of the test substance died within one day. No mortality occurred in the other dose groups.
- Clinical signs:
- other: 175 mg/kg (1 animal) and 550 mg/kg (1 animal) Dose Levels: There were no signs of adverse clinical signs. 1,750 mg/kg Dose Level (3 animals): Clinical signs observed for two animals included ano-genital staining and/or hypoactivity. However, the animals r
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period, except the four rats that were administered the highest dose level (5,000 mg/kg). Gross necropsy of these four rats revealed discoloration of the intestines.
Any other information on results incl. tables
Results are provided in Table 1 below.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of Myclobutanil was found to exceed 1750
mg/kg of body weight in female rats, and was lower than 5000 mg/kg bw/day. - Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with female Fischer 344 rats. Prior to use, the test substance was ground to a powder then mixed with a 1.5% w/w solution of carboxymethylcellulose (CMC) in distilled water to form a 25% w/w suspension. An initial limit dose of 5,000 mg/kg was administered to one healthy female rat by oral gavage. Due to mortality in this animal, the study proceeded to the Main Test. Using the default starting level of 175 mg/kg and following the Up and Down procedure, eight additional females were dosed at levels of 550, 1,750, or 5,000 mg/kg bw. All animals dosed at 5,000 mg/kg bw/day died within one day, no further mortality occurred. No effects on body weight gain were observed in the surviving rats. No clinical signs, abnormal behaviour and gross necropsy findings were noted for rats dosed at 175 and 550 mg/kg bw/day. At 1,750 mg/kg bw clinical signs were observed for two animals including ano-genital staining and/or hypoactivity. The animals recovered by Day 3. No necropsy findings were noted.
Under the conditions of this study, the acute oral LD50 of the test substance was found to exceed 1750 mg/kg of body weight in female rats, and was lower than 5000 mg/kg bw/day.
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