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EC number: 927-957-5 | 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
Endpoint summary
Administrative data
Description of key information
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:
- From September 04, 2017 to September 17, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment No 19, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Lot No.: WD0066442; Purity: 100 % (UVCB); Appearance: homogeneous, amber liquid
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Wistar rats
Source: Dobrá Voda, Slovak Republic
Age at First Dose: 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health: health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air conditioning. The average room temperature was maintained within the range of 23.2 ± 0.3 °C, relative humidity within 55.3 ± 2.5 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
Diet: The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodical analysed and recorded; certificate of analysis is included in the raw data.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany.
Animals Identification: The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the test substance.
Justification forthe Choice of Species: Normally females are used for testing OECD TG 423 because females are typically the more sensitive gender. - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Dose Preparation: The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration.
Dose Administration: The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld overnight). Following a period of fasting, animals were weighed and the test substance administered. After test article administration, food was withheld for further 3-4 hours. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- A limit dose of 2000 mg/kg bw was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose.
Clinical Observation: Animals were observed individually immediately after administration of the test substance and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight: Individual weights of animals were measured immediately prior to test substance was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
Necropsy: All test animals were subjected to gross necropsy and the results were recorded for each animal. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reactions.
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic findings were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to Wistar rats.
- Executive summary:
A study was conducted to determine the potential toxic effect of the test substance when administered as a single oral dose to Wistar rats according to the OECD Guideline 423 Acute Toxic Class (ATC) method, in compliance with GLP. Available information indicated that the test substance is likely to be non-toxic, therefore, 2000 mg/kg bw was used as a starting dose. Two groups of 3 females received the test substance and all 6 survived. The limit dose of 2000 mg/kg bw did not cause death, evident signs of toxicity during the 14 d observation period. Stagnation of bodyweight in 3 animals between the first and second week was observed. During necropsy, no macroscopic findings were noted. Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to Wistar rats (Hozova, 2017).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
Oral
A study was conducted to determine the potential toxic effect of the test substance when administered as a single oral dose to Wistar rats according to the OECD Guideline 423 Acute Toxic Class (ATC) method, in compliance with GLP. Available information indicated that the test substance is likely to be non-toxic, therefore, 2000 mg/kg bw was used as a starting dose. Two groups of 3 females received the test substance and all 6 survived. The limit dose of 2000 mg/kg bw did not cause death, evident signs of toxicity during the 14 d observation period. Stagnation of bodyweight in 3 animals between the first and second week was observed. During necropsy, no macroscopic findings were noted. Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to Wistar rats (Hozova, 2017).
Justification for classification or non-classification
Based on the acute oral toxicity study in Wistar rats, the substance does not warrant classification for acute toxicity according to EU CLP (EC 1272/2008) criteria.
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