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EC number: 444-860-9 | CAS number: 474510-57-1
- 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
The test item was administered orally by gavage to male and female Wistar rats (F0 animals) at dose levels of 0, 10, 30 and 90 mg/kg bw/day (OECD 422). Treatment-related adverse local irritative effects in the stomach were observed in all test item-treated groups at incidences of 1, 2 and 2 animals at the dose levels 10, 30 and 90 mg/kg body weight/day, respectively. In addition, decreased body weight gain and lowered motor activity were observed. Treatment-related adverse local irritative effects in the stomach were observed in all test item-treated groups at incidences of 1, 2 and 2 animals at the dose levels 10, 30 and 90 mg/kg body weight/day, respectively.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 30 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
Procedure and observations
The test item was administered orally by gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg body weight/day (CMC as vehicle), 10 mg/kg bw/d, 30 mg/kg bw/d and 90 mg/kg bw/d. The duration of treatment covered a 2-week premating and a mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation and 2 weeks thereafter in females. A detailed clinical observation was performed in all animals. Body weights and food consumption were determined in F0 animals. Clinicochemical and hematological examinations as well as urinalyses and FOB were performed in all animals towards the end of the administration period. All animals were assessed by gross pathology; weights of selected organs were recorded and a histopathological examination was performed.
At 90 mg/kg body weight/day, one male was killed for ethical reason, relationship to the treatment could not be excluded. Test item-related clinical signs, i.e. hunched posture, ruffled fur and discoloured feces, were observed of males and females of the high dose group. Food consumption and body weight gain in high dose males and females was found to be lower when compared to control. The animals showed also a slightly lower motor activity. Liver weights were increased in group 4 (90 mg/kg body weight/day). Additionally, thymus weights were decreased in females of the 90 mg/kg body weight/day group. Treatment-related adverse local irritative effects in the stomach were observed in all test item-treated groups at incidences of 1, 2 and 2 animals at the dose levels 10, 30 and 90 mg/kg body weight/day, respectively. Thymus atrophy and lowered thymus weight as well as liver cell hypertrophy was observed in (mid and) high dose animals.
Discussion
The reduced size in thymus in females, occurring in increased incidences, at ≥ 10 mg/kg body weight/day correlated histopathologically with athropy and reduced absolute and relative thymus weights only at the high dose levels. Although this is considered to be most likely to be stress related a test item-relationship cannot be excluded at the 90 mg/kg body weight/day dose level.
Treatment-related diffuse liver cell hypertrophy at 90 mg/kg body weight/day was considered to be adaptive. This hypertrophy was associated with follicular cell hypertrophy in thyroid glands in some males and females at 90 mg/kg body weight/day. Most probably the enhanced liver cell metabolism resulted in an acceleration of thyroid hormone breakdown with consequent thyroid follicular cell hypertrophy. This finding is commonly seen in rats after being exposed to xenobiotics.
The No-observed-effect-level for systemic toxicity is considered to be 30 mg/kg bw/day.
In addition to the above mentioned OECD 422 study, two range finding studies and a 28 day study were performed. In the course of the subacute study, 5, 50 and 160 mg/kg bw/day were administered by gavage to male and female wistar rats. Due to mortality in the high dose group an additional group was treated with 100 mg/kg bw/day. Similar to the findings of the OECD 422 study, gastric erosions were observed. Additionally, an adverse, nephrotoxic effect could be recorded in animals treated with 50, 100 and
160 mg/kg/day. The NOAEL was established at 5 mg/kg bw/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for repeated dose toxicity under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008.
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