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EC number: 483-300-8 | CAS number: 99580-93-5
- 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
LD50, oral > 2000 mg/kg bw
LD50, dermal > 2000 mg/kg bw
acute Tox. inhalation: waived
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 2007-11-20 till 2007-12-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: Wistar Hsd:HanRcc (SPF)
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Aqua ad inject
- Control animals:
- no
- Statistics:
- not necessary
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
- Clinical signs:
- Signs of toxicity related to dose levels:
No treatment related effect was observed during the course of the study. - Body weight:
- Throughout the 14-days observation period weight loss was recorded for animal 2 in step 1, loosing weight between the first and the second week. No weight loss was recorded in any other animal. The weight gain was within the expected range.
- Gross pathology:
- Effects on organs:
No treatment related effects were observed in any animal of any steps. - Other findings:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item shows no orally toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test item was classified into Category 5 (LD50 cut-off: unclassified).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP compliant study with Klimisch score 1
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
- Study period:
- from 2007-11-26 till 2007-12-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 92/69/EWG, B.3
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain:
rat, Wistar Hsd:HanRcc (SPF) - Type of coverage:
- semiocclusive
- Vehicle:
- other: aqua ad inject
- Duration of exposure:
- 24 h
- No. of animals per sex per dose:
- 5 males/ 5 females
- Control animals:
- no
- Statistics:
- not necessary
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
No treatment related effects observed. - Body weight:
- see Table 1
- Gross pathology:
- Effects on organs:
No treatment related effects observed. - Other findings:
- Signs of toxicity (local):
No treatment related effects observed. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item has no acute dermal toxic characteristics. The dermal LD50 was determined to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP compliant study with Klimisch score 1
Additional information
In both studies, oral and dermal, no clinical signs of toxicity were observed throughout the observation period. Except for acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in any animals. Weight gain of all animals was within the expected range.
Justification for selection of acute toxicity – oral endpoint
The only existing study is sufficient
Justification for selection of acute toxicity – inhalation endpoint
Inhalation is not expected to be a relevant exposure path for the substance. The substance as a salt has a very low vapour pressure and after manufacturing and processing it remains embedded into polymer matrix.
Justification for selection of acute toxicity – dermal endpoint
The only existing study is sufficient
Justification for classification or non-classification
According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding acute toxicity to mammals.
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