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EC number: 220-618-6 | CAS number: 2835-95-2
- 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
According to the results of the in vivo key studies (Acceptable study followed basic scientific principle, Klimisch 2). The NOAEL No Observed Adverse Effect Level was defined at 180 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 180 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
By gavage during 90 days: a first study was performed with similar OECD guideline 408. Males and females rats were treated daily by oral gavage with the registered test item for 13 weeks with diluted in 0.1% gelatin 25000 swelling. Doses used were 0, 300, 900 and 2700 mg/kg bw/day. Mortality and clinical signs were recorded at least once daily; body weights, water and food consumption were recorded weekly during the treatment period. Clinical laboratory investigations (haematology, blood/clinical biochemistry) as well as urinalysis were carried out before the start of administration and twice during the treatment period. All animals were subjected to a detailed necropsy. However, there was a deviation: animals were treated only 5 days per week instead of 7. The main toxic effects in this study were local irritation on the stomach mucosa, hepatotoxicity and toxic effects on the red blood cells, and a transient effects on the general behaviour immediately after application in the beginning of the study. Although of less severity, some of these effects were observed at the lowest dose level. Hence, particularly due to the effect observed at the low dose level (organ weight changes), no NOAEL can be derived. The LOAEL was defined as 300 mg/kg bw/day. (Hofer, 1978-1979).
A secondary gavage study during 90 days with the same method was performed at lowest doses to investigate a non-effect dose. This study focused on three effects observed in the precedent assay: (1)disturbed general condition with central nervous symproms immediately after the administration (2) decrease in the number of red blood cells (decrease of hematocrit) and (3) increased relative liver weight. No toxicity was observed during the treatment period at all the tested doses. The NOAEL (No observed adverse effect level) was defined as 180 mg/kg bw/day. (Hofer, 1978-1979).
One relevant in vivo study was performed in order to evaluate the potential toxicity of the registered substance during repeated exposure by oral route (feeding studies). Sprague Dawley rats were exposed continuously to test item mixed in diet at 0.21% in diet (equivalent to 180.9 and 205.88 mg/kg bw/day in males and females respectively), 0.95% in diet (equivalent to 818.35 and 931.37 mg/kg bw/day in males and females respectively) and 2.95% in diet equivalent to 2541.2 and 2892.16 mg/kg bw/day in males and females respectively). They were exposed for 90 days. All animals were observed once daily for mortality/morbidity and once weekly for signs of pharmacological or toxicological effects. Body weights and food consumption were recorded once weekly. Following blood collection from animals via cardiac puncture, the animals were subjected to necropsy and gross pathology. Tissues from all major organs of control and high dose groups were collected and evaluated histopathologically. In addition, liver, urinary bladder, thyroid, kidneys and all gross lesions from mid and low dose group animals were also examined microscopically.
In this 90 days study,with the exception of visibly enlarged thyroids in the animals treated with 1.0 and 3.0%, there were no consistent external or internal abnormalities or gross lesions observed in treated animals that could be related to treatment. Microscopic examination of the organs revealed test material dose related changes in the thyroid glands in the animals treated at all dose levels. The changes noted were a combination of mild to moderate follicular cell hyperplasia, misshapen follicles, and small follicles. The appearance of these glands was similar to that of a "sporadic microfollicular goiter”.
This effect is caused by an increase in the cell size of the columnar epithelium surrounding the follicles in the thyroid. Centrilobular hepatocytomegaly was noted in livers of several test animals (1 male and 1 female at the low dose, 2 males at mid dose and in 4 males and 3 females in the high dose group) and may reflect the site of metabolism of the drug. The few changes in other tissues were distributed among test and control rats and were considered spontaneous incidental lesions.
Justification for classification or non-classification
The NOAEL = 180 mg/kg bw/d
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