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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
The oral LD50 in Wistar rats was demonstrated to be greater than 2000 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 October 2020 to 17 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Acute oral toxicity (2-1-1),
- Version / remarks:
- 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 152 to 169 g
- Fasting period before study: Overnight prior to and approximately four hours after dosing
- Housing: In groups up to four in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days
- Method of randomisation in assigning animals to test and control groups: The animals were allocated without conscious bias to cages within the treatment groups.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 40 to 70%
- Air changes: Periodic checks were made on the number of air changes in the animal rooms.
- Photoperiod: Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours. - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: The test material was ground using a pestle and mortar and formulated at concentrations of 30 and 200 mg/mL in the vehicle, by adding the vehicle to the test material and mixing. The test material formulations were prepared on the day of dosing. - Doses:
- 300 and 2000 mg/kg body weight
- No. of animals per sex per dose:
- 1 animal was dosed at 300 mg/kg body weight
5 animals were dosed at 2000 mg/kg body weight - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cages of rats were checked at least twice daily for any mortalities. Animals were also observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day. The weight of each rat was recorded on Days -1 (not reported), 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: Yes. All animals were humanely killed on Day 15 by carbon dioxide asphyxiation and subsequently exsanguinated. All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. - Preliminary study:
- Two single animals were treated with a starting dose level of 300 mg/kg body weight and 2000 mg/kg body weight. In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of animals were treated at a dose level of 2000 mg/kg body weight.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality.
- Clinical signs:
- There were no clinical signs of reaction to treatment throughout the study.
- Body weight:
- Female number 36 (main study) was considered to have a low body weight gain between Day 8 and 15, however, achieved a satisfactory body weight gain between Day 1 and 8.
All other animals were considered to have achieved satisfactory body weight gains throughout the study. - Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the acute median lethal oral dose (LD50) to Wistar rats of the test material was demonstrated to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute oral toxicity potential of the test material to the rat was assessed according to the standardised guidelines OECD 420 and EU Method B1 bis under GLP conditions using the Fixed Dose Method.
Fasted female rats received a single oral gavage dose of the test material, formulated in 1% w/v aqueous methylcellulose. A sighting investigation was completed in which two animals received test material at dose levels of 300 and 2000 mg/kg body weight. Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight. During the study, clinical condition, body weight and macropathology investigations were undertaken and all animals were observed for 14 days after dosing. There were no deaths during the study and no clinical signs of reaction to treatment throughout the study. Female number 36 (main study) was considered to have a low body weight gain between Day 8 and 15, however, achieved a satisfactory body weight gain between Day 1 and 8. All other animals were considered to have achieved satisfactory body weight gains throughout the study and no abnormalities were noted in any animal at the macroscopic examination at study termination.
Under the conditions of this study, the acute median lethal oral dose (LD50) to Wistar rats of the test material was demonstrated to be greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- One study is available, conducted in accordance with standardised guidelines under GLP conditions. The quality of the database is therefore considered to be high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral
The acute oral toxicity potential of the test material to the rat was assessed according to the standardised guidelines OECD 420 and EU Method B1 bis under GLP conditions using the Fixed Dose Method.
The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Fasted female rats received a single oral gavage dose of the test material, formulated in 1% w/v aqueous methylcellulose. A sighting investigation was completed in which two animals received test material at dose levels of 300 and 2000 mg/kg body weight. Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight. During the study, clinical condition, body weight and macropathology investigations were undertaken and all animals were observed for 14 days after dosing. There were no deaths during the study and no clinical signs of reaction to treatment throughout the study. Female number 36 (main study) was considered to have a low body weight gain between Day 8 and 15, however, achieved a satisfactory body weight gain between Day 1 and 8. All other animals were considered to have achieved satisfactory body weight gains throughout the study and no abnormalities were noted in any animal at the macroscopic examination at study termination.
Under the conditions of this study, the acute median lethal oral dose (LD50) to Wistar rats of the test material was demonstrated to be greater than 2000 mg/kg body weight.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral route
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