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Diss Factsheets
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EC number: 423-340-5 | CAS number: 162881-26-7 CGI 819
- 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
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Endpoint summary
Administrative data
Description of key information
Oral subacute and subchronic toxicity studies are available. The studies were conducted according to the OECD TG 407 (1981) and OECD 408 (1998) and were GLP-conform. Sprague-Dawley rats of both sexes were daily treated with the test substance by gavage during 4 weeks. No obvious signs of toxicity were seen. The NOAEL was established at 1000 mg/kg bw/day for subacute and for 300 mg/kg bw for subchronic exposure.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- 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
An oral subacute, 28-day repeated dose oral (gavage) toxicity study was conducted according to the OECD TG 407 (1981) and was GLP-conform, followed by a 2 -week recovery period (Huntingdon Life Sciences Ltd 964059).
Based on a 7-day range-finding study (Huntingdon Life Sciences Ltd 964058), the dose levels were selected as 0, 15, 150 and 1000 mg/kg bw/day.
Each of the groups comprised 5 animals per sex 5 animals per sex and group. Following the 4-week treatment period, another five males and five females of the control and the high dose group were allowed a 2 -week period without treatment.
No obvious signs of toxicity were observed. Since all findings reported were incidental and/or within the range of background no treatment-related effects could be derived. The highest tested dose level of 1000 mg/kg bw/day was established as the NO(A)EL.
For the OECD 408 study, the substance was administered by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 mg/kg body weight/day (drinking water with 1% carboxymethyl cellulose served as vehicle control; test group 0), 100 mg/kg bw/d (test group 1), 300 mg/kg bw/d (test group 2) and 1000 mg/kg bw/d (test group 3) over a period of 92 days (male animals) / 93 days (female animals) (BASF 2014).
Food consumption and body weights were determined weekly. The rats were examined for signs of toxicity or mortality at least once a day. In addition, the rats were daily examined for any clinically abnormal signs. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Ophthalmological examinations were performed before the beginning and at the end of the administration period. A functional observational battery (FOB) and measurement of motor activity (MA)were carried out on study days 86 and 90 in males and on study days 87 and 91 in females.
Clinicochemical and hematological examinations as well as urinalyses were performed towards the end of the administration period. After the administration period all rats were sacrificed and assessed by gross pathology, followed by histopathological examinations.
No treatment-related, adverse clinical effects were observed. No adverse findings were observed for histopathology, gross necropsy, urinalyis, functional observation battery and opthalmoscopy. At the highest dose group of 1000 mg/kg bw, increased hemoglobin and hematocrit values in both sexes were found. In males only, increased red blood cell counts and decreased total protein and albumin values were detected.
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. No serious irreversible effects were observed at dose levels of less than 50 mg/kg bw upon subchronic exposure. As a result the substance is not considered to be classified for repeated dose toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. There were no significant toxic effects at doses of less than 100 mg/kg bw upon subchronic oral exposure in rats. As a result the substance is not classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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