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Diss Factsheets
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EC number: 224-436-8 | CAS number: 4359-47-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: OECD TG 401: 7100 mg/kg bw.
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:
- The study was conducted in May 1978.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and there is no documentation on experimental conditions. The study is also non-GLP. Except for that, the total number of tested animals was 4 instead of 5 and they were not all of the same sex.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The total number of tested animals was 4 instead of 5 and they were not all of the same sex.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were in the weight range 250-320 g (males) and 135-188 g (females) at the initiation of the study. Rats were housed in groups of two in screen-bottomed stainless steel cages, in a well-ventilated room, maintained at 23-25°C.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Syvertal was administered at the appropriate doses to each rat by oral gavage. Before dosing, the rats were fasted overnight.
- Doses:
- Five doses were used in the study: 1250, 2500, 5000, 10000 and 20000 mg/kg bw.
- No. of animals per sex per dose:
- 4 rats per dose, 2 per sex per dose: 2 males and 2 females.
- Control animals:
- no
- Details on study design:
- - After treatment the rats received stock diet and tap water ad libitum
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 7 100 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred at the doses of 1250, 2500 and 5000 mg/kg bw. All 4 animals died after treatment with the doses 10000 and 20000 mg/kg bw. Deaths occurred between 2 hours and 3 days after dosing.
- Clinical signs:
- Rats receiving the doses of 1250 and 2500 mg/kg bw did not show any reaction to the treatment and the rats looked quite healthy during the whole observation period. Rats receiving the dose of 5000 mg/kg bw showed sluggishness within a few hours after dosing. One male in the 5000 mg/kg bw group and all rats dosed 10000 and 20000 mg/kg bw lost consciousness. The survivors recovered and looked quite healthy again at the end of the observation period.
- Gross pathology:
- Terminal necropsy of the survivors revealed no treatment-related gross alterations.
- Other findings:
- No other findings were noted.
- Interpretation of results:
- other: Not classified.
- Remarks:
- According to EU CLP 1272/2008 and its amendments.
- Conclusions:
- Acute oral toxicity was performed similar to the guideline OECD TG 401. The acute oral LD50 for the substance in male and female rats was determined to be 7100 mg/kg bw.
- Executive summary:
Acute oral toxicity was performed similar to the guideline OECD TG 401. Four rats (males and females) per dose were administered the substance at doses: 1250, 2500, 5000, 10000 and 20000 mg/kg bw. No deaths occurred at the doses of 1250, 2500 and 5000 mg/kg bw. All 4 animals died after treatment with the doses 10000 and 20000 mg/kg bw. The clinical signs observed during the study included: sluggishness, losing consciousness and death.Gross autopsy of the survivors did not demonstrate any treatment-related gross alterations. The acute oral LD50 for the substance in male and female rats was determined to be 7100 mg/kg bw, therefore the substance is not acute toxic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity was performed similar to the guideline OECD TG 401. Four rats (males and females) per dose were administered the substance at doses: 1250, 2500, 5000, 10000 and 20000 mg/kg bw. No deaths occurred at the doses of 1250, 2500 and 5000 mg/kg bw. All 4 animals died after treatment with the doses 10000 and 20000 mg/kg bw. The clinical signs observed during the study included: sluggishness, losing consciousness and death.Gross autopsy of the survivors did not demonstrate any treatment-related gross alterations. The acute oral LD50 for the substance in male and female rats was determined to be 7100 mg/kg bw, therefore the substance is not acute toxic.
Justification for classification or non-classification
According to the criteria outlined in EU CLP 1272/2008/EC (and its amendments), the substance does not have to be classified as acute toxic by the oral route.
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.
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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