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EC number: 946-245-5 | CAS number: -
- 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
In an oral (diet) Combined Repeated Dose Toxicity Study with Reproduction / Developmental Toxicity Screening Test in rats (10-week premating period), performed according to OECD guideline 422, the mid-dose level of 750 mg/kg diet was a NOAEL for systemic toxicity. This dietary concentration provided ca. 42 mg/kg bw/day in male rats and ca. 41 mg/kg bw/day in female rats (based on nominal dietary test material concentration corrected for 27% loss on storage in animal room for one day). At the high-dose level (2500 mg/kg diet and circa 120 mg/kg bw/day) body weight and food consumption were decreased in both sexes and total and differential white blood cell counts were decreased in male rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 41 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The repeated dose toxicity study using an extended OECD TG 422 protocol is adequate for covering this endpoint and can be used as a replacement for the 90-day study.
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
OECD 422 study including 10 -week pre-mating period
The toxicity upon repeated oral exposure was examined in a study performed according to OECD guideline 422 and in compliance with GLP. Groups of 12 male and 12 female Wistar rats received the test material via their diet, at concentrations of 0, 200, 750 and 2500 mg/diet during a 10-week premating period and during mating (one week), gestation and lactation until postnatal day 4. The total exposure duration was up to 83 days in male rats and up to 103 days in female rats. Homogeneity and correct concentration of the test material in the diet were confirmed by analysis. The test substance was not stable in the diet upon storage in the animal room. The decrease in concentration during a 1-day storage period was 18%, 27% and 22% at the low-, mid- and high-dose, respectively. To minimize loss of test material under experimental conditions as much as possible, the feed in the feed hoppers was replaced daily by a fresh portion from the freezer (stability in the freezer was confirmed by analysis). Moreover, the fresh feed was provided in the afternoon instead of in the morning because rats eat most of their feed during the dark period. These doses resulted in final mg/kg bw of circa 10, 40 and 120 mg/kg bw. The following endpoints were evaluated to assess general toxicity: daily clinical observations, neurobehavioural examination (grip strength; functional observational battery including sensory reactivity to different stimuli; spontaneous motor activity), body weight, food consumption, routine haematology and clinical chemistry (in week 10 of the premating period), organ weights, macroscopic examination and histopathological examination of a wide range of tissues and organs (except for the kidneys which were examined in all groups, only high-dose animals and controls were subjected to histopathology). Endpoints to assess reproductive / developmental toxicity included parental fertility and reproductive performance (including sperm analysis) and litter data are discussed in Section on Toxicity to reproduction.
The results showed no treatment-related changes at circa 10 and 40 mg/kgbw. At circa 120 mg/kg bw, body weight (gain) and food consumption were statistically significantly decreased during the entire or substantial parts of the study in rats of both sexes, and total and differential white blood cell counts were decreased in male rats (40%). In addition, male rats showed renal changes consisting of an increased relative kidney weight (at the high-dose level) and a dose-dependent increase of alpha 2-microglobulin nephropathy. This type of nephropathy in male rats is generally regarded as of no relevance for humans. The changes in clinical chemistry values in male rats (higher chloride at all dose levels and lower potassium at the high-dose) might be related to the nephropathy.
Based on these results the NOAEL for general toxicity was 750 mg/kg diet. This dietary level provided ca. 42 mg/kg bw/day in male rats and ca. 41 mg/kg bw/day in female rats (based on the overall mean substance intake during the premating period). The intake of the test material per kg body weight was calculated from the nominal dietary concentration corrected for the loss measured after storage in the animal room for one day.
Justification for classification or non-classification
The NOAEL is set at 41 mg/kg bw. This, however, does not warrant a STOT 2 classification, because the effects seen at 100 mg/kg bw do not indicate effects as mentioned at 3.9.2.7.3 of the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, such as morbidity, functional changes in the nervous system, significant changes in haematology parameters and/or significant organ damage.
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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