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Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-11-04 to 2017-01-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- dated December 17th, 2001
- Deviations:
- yes
- Remarks:
- Environmental parameters : relative humidity lower than 30% (minimum = 21%) and tempearature lower than 19°C (minimum = 18°C) reported - these deviations are considered without impact on the conclusion of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dated October 23rd, 2015
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS, Le Genest St Isle, France
- Age at study initiation:8 or 9 weeks old at the beginning of the study
- Weight at study initiation: 196 - 226 g (fasted body weight)
- Fasting period before study: The rats were fasted approx. 1 day prior to dosing, with food being returned to the rats 4 hours after dosing.
- Housing: Animals were housed by group of three in solid-bottomed clear plycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust and was installed in conventional air conditioned animal husbandry
- Diet (ad libitum): Envigo - 2016
- Water: ad libitum
- Acclimatization period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
- Rate of air exchange : at least 10 changes per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: none for the first step of the study and olive oil for second and third steps
- Details on oral exposure:
- In the first step of the study, the test item was administered by gavage under a volume of 1.95 mg/kg body weight (corresponding to 2g/kg, according to the calculated density) using a suitabe graduated syringue fitted with an oesophageal canula.
In the second and third steps of the study, for each step, 0.29 mL of the test item (corresponding to 300 mg) were added to 1.66 mL of olive oil. The preparations were stirred by vortex to obtain blue solutions just before the administration.
Each preparation was administered under a volume of 1.95 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula. - Doses:
- 2000 and 300 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg: three females
300 mg/kg: 6 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Daily examination: Systematic examination were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. These observations were compared to historical control data. Observations and a mortality report were then carried out every day for 14 days.
- Periodical examinations: The animals were weighed on D0 (just before administering the test item) then on D2, D7 and D14. Weight changes were calculated and recorded.
- Examination at the end of the test: On D14, the animals were anesthetised with sodium pentoarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: In accordance with the O.E.C.D. test guideline n° 423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight.
- Mortality:
- Three mortalities were noted in animals treated at the dose of 2000 mg/kg body weight, at 24 hours post-dose.
No mortality occured during the study at the dose of 300 mg/kg body weight. - Clinical signs:
- other: other: At the dose of 2000 mg/kg body weight, the mortalities were preceeded by an absence or decrease of spontaneous activity (3/3), muscle tone (3/3), righting reflex (3/3), Peeyer's reflex (3/3), associatd with bradypnea (3/3), hypothermia (3/3), eyes
- Gross pathology:
- At the dose of 2000 mg/Kg body weight, the macroscopic examination of the animals revealed remains important test item in the stomach (3/3), blue coloration of a forestomach and corpus (3/3) and cellular lysis of main organs in the abdomen (1/3).
At the dose of 300 mg/Kg body weight, the macrosscopic examination of the animals at the end of the study did not reveal treatment related changes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test item is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight by oral route in the rat.
In accordance with the O.E.C.D. test guideline n° 423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the Regulation EC n°1272/2008, the test item has to be classified in category 4. The signal word 'Warning' and hazard statement H302 'Harmful if swallowed' are required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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