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Diss Factsheets
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EC number: 214-294-5 | CAS number: 1120-02-1
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 26 to August 31, 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
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Intercure 18
- IUPAC Name:
- Intercure 18
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: body weight variation did not exceed ± 20 % of the mean body weight
- Fasting period before study: overnight fast immediately before dosing
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum):
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): fifteen changes
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- SIGHTING TEST
Using available information on the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
A single animal was treated as follows:
Dose Level (mg/kg)= 300
Concentration (mg/mL) = 30
Dose Volume (mL/kg) = 10
Number of Rats (Female) = 1
In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was treated as follows:
Dose Level (mg/kg)= 2000
Concentration (mg/mL) = 200
Dose Volume (mL/kg) = 10
Number of Rats (Female) = 1
MAIN STUDY
Due to mortality and signs of systemic toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose Level (mg/kg)= 300
Concentration (mg/mL) = 30
Dose Volume (mL/kg) = 10
Number of Rats (Female) = 4 - Doses:
- SIGHTING TEST: 300 mg/kg, 2000 mg/kg
MAIN STUDY: 300 mg/kg - No. of animals per sex per dose:
- 300 mg/kg (1animal during Sighting Test)
2000 mg/kg (1 animal during Sighting Test)
300 mg/kg (4 animals during Main test) - Control animals:
- no
- Details on study design:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animal treated at a dose level of 2000 mg/kg was found dead 1 day after dosing. There were no deaths at a dose level of 300 mg/kg.
- Clinical signs:
- other: Hunched posture was noted 2 and 4 hours after dosing in the animal treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity at a dose level of 300 mg/kg
- Gross pathology:
- Abnormalities noted at necropsy of the animal treated at a dose level of 2000 mg/kg were abnormally red lungs, dark liver, dark kidneys and white material present in the stomach. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 According to the CLP Criteria
- Conclusions:
- The LD50 of the test substance is in a range of 300 - 2000 mg/kg bw.
- Executive summary:
Method
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat, according to the OECD guideline 420.
Following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 300 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. The animal treated at a dose level of 2000 mg/kg was found dead 1 day after dosing. There were no deaths at a dose level of 300 mg/kg.
Clinical Observations. Hunched posture was noted 2 and 4 hours after dosing in the animal treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity at a dose level of 300 mg/kg.
Body Weight. Surviving animals showed expected gains in body weight.
Necropsy. Abnormalities noted at necropsy of the animal treated at a dose level of 2000 mg/kg were abnormally red lungs, dark liver, dark kidneys and white material present in the stomach. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg bw.
Conclusion
The LD50 of the test substance is in a range of 300 - 2000 mg/kg bw.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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