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Registration Dossier
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EC number: 298-265-2 | CAS number: 93783-70-1
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Waiving.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Pregnant rats dosed during organogenesis: NOAEL = 15 mg/kg/day, corresponding to ca. 13 mg/kg a.i..
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 13 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study well conducted and documented; details available.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Preliminary teratology study
Method
Groups of 6 sexually mature female rats administered by gavage 0, 5, 20, 80 mg/kg/day from day 6 to 15 of gestation. All females were sacrificed on day 20.
Results
No adverse effects were noted at a dose of 5 mg/kg/day; transient effects in terms of reduced weight gain and food intake were noted at 20 mg/kg/day (17 mg/kg a.i.); marked adverse effects were reported at 80 mg/kg/day (68 mg/kg a.i.), where 5/6 females were terminated before the end of the treatment. No indication of teratogenic effects was noted.
Main teratology study
Method
Groups of 21 sexually mature female rats administered by gavage 0, 1.5, 5, 15 mg/kg/day from day 6 to 15 of gestation. All females were sacrificed on day 20.
Results
No effects on general conditions of dams, body weight, food intake were noted. In addition, there were no adverse effects upon litter size, post-implantation survival or foetal and placental weights. Ossification of the foetal posterior cranial bones was slightly reduced, in a statistically significant way only at 15 mg/kg/day (13 mg/kg a.i.), but there were no adverse morphological changes considered to be treatment-related.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, adverse effects on developmental toxicity in the offspring and adverse effects on or via lactation.
Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans.
Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1.
Test substance did not show any evidence of reproductive toxicity in a test covering organogenesis. The only finding was a slightly reduced ossification of the foetal posterior cranial bones, but there were no adverse morphological changes that were considered to be treatment related. On these bases, the substance is considered as non toxic for reproduction.
Additional information
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