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EC number: 605-146-4 | CAS number: 158451-78-6
- 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
The test substance showed no systemic toxicity in an OECD 422 guideline study.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a GLP-compliant repeated dose toxicity study performed according to OECD guideline 422, the test substance formulated in water, was administered daily by oral gavage to SPF-bred Wistar Han rats at dose levels of 63, 250 and 1000 mg/kg bw/day (10 rats/sex/dose level). The dose levels were based on a dose-range finding study performed previously. Concurrent controls (10 rats/sex) received the vehicle only. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 41-55 days, i.e. during 2 weeks prior to mating, during mating, during post-c oitum, and during at least 4 days of lactation. The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), functional observations and locomotor activity (end of treatment), body weight and food consumption (at least at weekly intervals), clinical pathology (end of treatment), macroscopy at termination, organ weights and histopathology on a selection of tissues, and reproduction/developmental parameters, consisting of mating, fertility and conception indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weights and macroscopy). Accuracy, homogeneity and stability of formulations were demonstrated by analyses. Local adverse effects were observed in the forestomach at 1000 mg/kg bw/day in both sexes. This was indicated by macroscopic changes (thickened fore stomach; irregular surface and grown together with the diaphragm) and microscopic alterations (erosion/ulceration with submucosal granulation tissue, hyperplasia, edema) which may reflect a response to damage of the forestomach epithelium by the test substance, including an interruption of the protective forestomach epithelium. No systemic parental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day). Slightly lower body weight (gain), accompanied by lower food consumption, was noted in males at 1000 mg/kg bw/day, which may be secondary to the local effects on the forestomach and was considered not to reflect systemic toxicity of the test substance. Particularly, the three males with the lowest overall lower body weight gain had marked histopathological findings at the forestomach. Microscopic examination showed an increased incidence of minimal mucosal hypertrophy in the cecum of females at 1000 mg/kg bw/day, which was regarded not to be adverse. A subtle increase in incidence of increased lymphocytolysis in the thymus was noted in females at 1000 mg/kg bw/day. One of the two affected females also had a marked forestomach ulcer and, therefore, the increased lymphocytolysis in the thymus of this female was regarded to be related to stress. Based on this and in view of the incidence and minimal severity, this finding in the thymus was regarded not to be adverse. In conclusion, treatment with the test substance by oral gavage in male and female Wistar Han rats at dose levels of 63, 250 and 1000 mg/kg bw/day revealed local parental toxicity (morphological changes in the forestomach) at 1000 mg/kg bw/day. No systemic parental toxicity was observed for treatment up to 1000 mg/kg bw/day. The NOAEL for local toxicity was determined to be 250 mg/kg bw/day and for systemic toxicity 1000 mg/kg bw/day, respectively.
Justification for classification or non-classification
Based on the available information classification for repeated dose toxicity is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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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