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EC number: 270-109-8 | CAS number: 68411-20-1
- 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
Endpoint summary
Administrative data
Description of key information
A valid oral toxicity study and a sufficient documented acute dermal toxicity study from a reliable source are available.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and suficient documented
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Six groups of 10 male Wister rats (average weight 160-180 g) received per gavage a single dose of 2000 to 6300 ml/kg bw Vulkacit 576. The animals were observed for mortality, weight and clinical signs through day 14.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000, 3100, 4000, 4500, 5000, 6300 µl/kg = 1990, 3084.5, 3980, 4477.5, 4975, 6268.5 mg/kg bw
According to EU Method A. 3, the relative density of the test item determined by use of an oscillating densitimeter (U-tube method) is 0.995 at 20° C (Bayer Technology Services, 2011). - No. of animals per sex per dose:
- 10 male animals/dose
- Control animals:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 830 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Six groups of 10 male Wister rats (average weight 160-180 g) received per gavage a single dose of 2000 to 6300 µl/kg bw Vulkacit 576. The animals were observed for mortality, weight and clinical signs through day 14.
The corresponding mortality for male rats was 0% (2000 µl/kg bw), 30% (3100 µl/kg bw), 40% (4000 µl/kg bw), 70% (4500 µl/kg bw), 90% (5000 µl/kg bw), 100% (6300 µl/kg bw), respectively.
A single dose of Vulkacit 596 caused on male rats the following signs of intoxication: sedation, diarrhoe, weight loss, reduction of general condition. The LD50 = 3830 mg/kg bw.
Reference
The corresponding mortality for male rats was 0% (2000 µl/kg bw), 30% (3100 µl/kg bw), 40% (4000 µl/kg bw), 70% (4500 µl/kg bw), 90% (5000 µl/kg bw), 100% (6300 µl/kg bw), respectively.
A single dose of Vulkacit 596 caused on male rats the following signs of intoxication: sedation, diarrhoe, weight loss, reduction of general condition.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 830 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
- Principles of method if other than guideline:
- Two male and 2 one female rabbit were applied the undiluted test substance for 24 hours. The animals were examined for mortality, clinical signs and a gross pathology was performed on survivors on day 14.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 5010 or 7940 mg/kg bw.
- No. of animals per sex per dose:
- 5010 mg/kg bw: 1 animal (male)
7940 mg/kg bw: 2 animals (male and female) - Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 7 940 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Two male and 2 one female rabbit were applied the undiluted test substance in doses of 5010 or 7940 mg/kg bw for 24 hours. The animals were exmained for mortality, clinical signs and a gross pathology was performed on surviviers on day 14. None of the animals died.
Therefore the LD50 is > 7940 mg/kg bw.
Reference
Signs of intoxication: reduced appetite and activity four to seven days. The survivors showed areas of slight liver dicoloration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 7 940 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described sufficient for evaluation
Additional information
In the acute oral toxicity study six groups of 10 male Wister rats (average weight 160-180 g) received per gavage a single dose of 2000 to 6300 µl/kg bw Vulkacit 576. The animals were observed for mortality, weight and clinical signs through day 14.
The corresponding mortality for male rats was 0% (2000 µl/kg bw), 30% (3100 µl/kg bw), 40% (4000 µl/kg bw), 70% (4500 µl/kg bw), 90% (5000 µl/kg bw), 100% (6300 µl/kg bw), respectively.
A single dose of Vulkacit 596 caused on male rats the following signs of intoxication: sedation, diarrhea, weight loss, reduction of general condition. The LD50 = 3830 mg/kg bw.
In the acute dermal toxicity study 2 male and 2 one female rabbit were applied the undiluted test substance for 24 hours. The animals were examined for mortality, clinical signs and a gross pathology was performed on survivors on day 14. None of the animals died.
Therefore the LD50 is > 7940 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Key study is used
Justification for selection of acute toxicity – dermal endpoint
key study is used
Justification for classification or non-classification
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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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