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EC number: 431-060-1 | CAS number: 153719-38-1
- 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 GLP guideline 28-day feeding study (OECD 407; Novartis, 1997) was conducted with dose levels of 0, 50, 200, 1000, 5000 ppm. At 1000 ppm, slight hepatotropic effects were noted in both sexes. A NOAEL of 200 ppm (15.7 mg/kg bw/d in females) was concluded. Several additional GLP non-guideline studies were conducted at higher doses (CTL, 2005, 28-day, 0-6000 ppm; Syngenta, 2006, 14-days, 0-400 mg/kg bw/d; Syngenta, 2006, 28-days, 0-400 mg/kg bw/d; RCC, 2007, 0-500 mg/kg bw/d. In addition a 90 day GLP guideline inhalation study (OECD 413, CTL, 2003) was conducted with aerosol concentrations from 0 to 0.25 mg/l. A NOAEC of 0.05 mg/l was established.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 15.7 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 50 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Additional information
Oral:
A GLP guideline 28-day feeding study (OECD 407; Novartis, 1997) was conducted with dose levels of 0, 50, 200, 1000, 5000 ppm. At 1000 ppm, slight hepatotropic effects were noted in both sexes. A NOAEL of 200 ppm (15.7 mg/kg bw/d in females) was concluded. The LOAEL is 1000 ppm (87.2 mg/kg bw/d (males)).
In addition, several GLP non-guideline studies were conducted at higher doses:
- 28 day feeding study (CTL, 2005; 0, 2000, 4000, 6000 ppm; corresponding to 0, 230, 470, and 680 mg/ kg bw/d in males and 0, 210, 440, and 590 mg/kg bw/d in females). At 6000 ppm, animals were sacrificed halfway through the test since they were deemed moribund. A LOAEL of 2000 ppm was determined based on reduced body weight and changes in haematological parameters.
- 14 day oral gavage study (Syngenta, 2006; 0, 100, 200, 400 mg/kg bw/d): Examinations were restricted to behavior, food consumption and body weight as well as gross pathology at the end of the study. Minimal effects were seen at the lowest dose. This study was intended as a range-finder for longer-term studies.
- 28 day oral gavage study (Syngenta, 2006; 0, 100, 200, 400 mg/kg bw/d): clear effect of 100, 200 and 400 mg/kg bw/d following a single dose; clinical signs (including decreased activity, piloerection, tip toe gait, cold) and weight loss in females and reduced food consumption in males and females. A dose-related effect of treatment on the body weights of the males was seen subsequently. For the males given 400 mg/kg/day, lower body weights persisted throughout day 29. The maximum effect was 19 % when compared with the controls. Lower body weights in females were not sustained after approximately one week of treatment. Lower food consumption was not sustained in males or females after one week of treatment. LOAEL is 100 mg/kg bw/d.
- 28 day oral gavage study (RCC, 2007; 0, 300, 400, 500 mg/kg/d): signs of toxicity at all dose levels.
Inhalation:
Nose-only exposure for 6 hours per day, 5 days per week over a period of 90 days at concentrations of 0.01, 0.05 or 0.25 mg/l resulted in lower body weight and food consumption and histopathological changes in the olfactory epithelium in both sexes exposed to 0.25 mg/l. There were no adverse effects of treatment in animals exposed to 0.05 mg/l (NOAEC).
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: nose
Justification for classification or non-classification
Guidance values for classification according to EC 1272/2008 are 10 < C <= 100 mg/kg/d (STOT RE, Category 2, oral) and 0.02 < C < 0.2 mg/l/6h/d (STOT RE, Category 2, inhalation, aerosol).
The oral LOAEL is at 87.2 mg/kg/d. The value is derived from a 28-day study. The CLP reference values are based on sub-chronic studies. Thus, this LOAEL would need to be extrapolated using a default factor of 3 (as recommended in the CLP regulation), resulting in an effect level of ca. 30 mg/kg/d. Both values are within the range of the guidance values for STOT RE, Category 2. However, there are only slight, mainly reversible, hepatotropic effects without corresponding histopathological findings. This is not considered sufficient to warrant a classification.
The inhalatory LOAEL of 0.25 mg/l is based on reduced body weight, reduced food consumption and histopathological changes in the olfactory epithelium. The NOAEL is at 0.05 mg/l. Hence there may be an effect at concentrations within the range of the guidance value (0.02 < C < 0.2 mg/l). However, the effects at 0.25 mg/l are not considered severe enough to warrant a classification.
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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