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EC number: 617-143-5 | CAS number: 80675-49-6
- 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
Oral:
In an in vivo repeated dose toxicity study in rats according to OECD guideline 407 (BASF SE, 2010), a NOAEL of > 1000 mg/kg bw/day was determined.
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
- Quality of whole database:
- GLP and guideline compliant study report.
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
Repeated dose toxicity: oral
In a subacute repeated dose toxicity study according to the OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), the test substance was administered in feed to male and female Wistar rats at dose levels of 0 ppm (test group 0), 1500 ppm (test group 1), 5000 ppm (test group 2) and 15000 ppm (test group 3) over a period of 4 weeks (BASF SE, 2010). Control and test group 3 (15000 ppm) consisted of 10 animals per sex each, whereas test groups 1 (1500 ppm) and 2 (5000 ppm) consisted of 5 animals per sex each. After 4 weeks of treatment 5 animals per sex of all test groups were sacrificed (main groups). The remaining 5 animals per sex of control and test group 3 (15000 ppm) were maintained for another 14 days without administration of the test substance (recovery groups).
Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity and mortality at least once a day. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Additionally, a functional observational battery (FOB) as well as measurement of motor activity (MA) was carried out at the end of the study. Clinicochemical and hematological examinations as well as urinalyses were performed towards the end of the administration period. An additional blood sampling in male animals only was performed at the end of the recovery period. All animals were assessed by gross pathology, followed by histopathological examinations. The following test substance-related, relevant findings were noted:
No treatment-related adverse effects were observed. A yellow discoloration in all animals of both sexes of test group 3 (15000 ppm) was observed, i.e. faeces and urine during the entire study period and fur from day 22 onwards, of test group 2 (5000 ppm), i.e. faeces and urine during the entire study period, and of test group 1 (1000 ppm), i.e. urine from day 7 onwards. Fur contamination occurs as a result of both the coloured feces and the coloured feed.
During the recovery period, the discoloration of faeces, urine and fur disappeared in all animals of test group 3 (15000 ppm; study day 31). This finding was clearly attributable to the ingestion and excretion of the test substance as the test substance is coloured. Its physical (tinctorial) properties do not represent a toxicologically relevant finding or adverse effect.
A NOAEL of > 15000 ppm (♂: > 1160 mg/kg bw/d; ♀: 1026 mg/kg bw/d) was determined.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The NOAEL was greater than 1000 mg/kg bw. As a result the substance is not considered to be classified for repeated dose oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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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