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Diss Factsheets
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EC number: 953-513-5 | 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 20 - July 7, 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- N/A
- Molecular formula:
- C10H16O2
- Test material form:
- liquid
- Remarks:
- Colorless
- Details on test material:
- Test substance was expected to be stable for the duration of testing.
Constituent 1
- Specific details on test material used for the study:
- - lot number of test material:
CH-DA-01-18
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Stored refrigerated
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
Test substance was expected to be stable for the duration of testing.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis:
The test substance was applied as received
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium:
The test substance was applied as received
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
Mixed well prior to use
- Preliminary purification step (if any):
None
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 9 - 12 weeks
- Weight at study initiation: 206 - 264 gram females
- Housing:
The animals were housed in caging which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Animals were group housed, except on the day of application, at which time they were singly housed until the animals were deemed acceptable, based on observations, to return to group housing. Enrichment (e.g., toy) was placed in each cage and litter was changed at least once per week.
- Diet (e.g. ad libitum):
Envigo Teklad Global 16% Protein Rodent Diet® #20 16. The diet was available ad libitum.
- Water: Filtered tap water was supplied ad libitum
- Acclimation period: 12 - 34 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24
- Humidity (%): 53 - 68
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION:
Individual doses were calculated based on the initial body weights, taking into account the density of the test substance - Doses:
- 175, 550, 1750, 5000 mg/kg
- No. of animals per sex per dose:
- 8 females, divided as follows:
175 mg/kg: 1
550 mg/kg: 1
1750 mg/kg: 3
5000 mg/kg:3 - Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
mortality, signs of gross toxicity, and behavioral changes approximately 30 minutes post-dosing, during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing or until death occurred. Individual body weights prior to test substance administration and on Days 7 and 14 following dosing or after death.
- Necropsy of survivors performed:
yes
- Clinical signs including body weight
gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. Individual body weights of the animals were recorded.
- Other examinations performed:
Gross necropsies were performed on all decedents and euthanized animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- Statistical analysis was performed for the calculation of the mean density value for dosing. In
addition, the Acute Oral Toxicity (Guideline 425) Statistical Program (Westat 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:
- 3 129 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Approximate 95% confidence interval of 1750 mg/kg (lower) to 5000 mg/kg (upper).
- Mortality:
- At the highest dose, all animals died within five hours of test substance administration. No deaths were observed at lower doses.
- Clinical signs:
- other: 175 mg/kg: irregular respiration and ataxia. 550 mg/kg: hypoactive and exhibited irregular respiration. 1750 mg/kg: one female was hypoactive and two females exhibited irregular respiration, ataxia, tremors, piloerection and/or reduced fecal volume. 5000
- Gross pathology:
- Gross necropsy of the decedents revealed distention of the stomach and/or a fluid-filled stomach.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of Dihydronepetalactone is estimated to be
3129 mg/kg of body weight (based on an assumed sigma of 0.5) in female rats with an
approximate 95% confidence interval of 1750 mg/kg (lower) to 5000 mg/kg (upper). - Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for Dihydronepetalactone to produce toxicity from a single dose via the oral route.
Based on a limit dose of 5000 mg/kg, a Main Test was conducted using a default starting dose level of 175 mg/kg which was administered to one healthy female rat by oral gavage. Following the Up and Down procedure, seven additional animals were dosed at levels of 550, 1750 or 5000 mg/kg. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing or until death occurred. Body weights were recorded prior to administration (initial) and again on Days 7 and 14 (terminal) following dosing or after death. Necropsies were performed on all animals.
Under the conditions of this study, the acute oral LD50 of the test substance is estimated to be 3129 mg/kg of body weight (based on an assumed sigma of 0.5) in female rats with an approximate 95% confidence interval of 1750 mg/kg (lower) to 5000 mg/kg (upper).
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