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EC number: 939-401-9 | CAS number: 1469983-41-2
- 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
Repeated dose oral 90day (OECDTG408): NOAEL female 6.8 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 6.8 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The study has klimisch code 1.
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 adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Species:
- rat
Additional information
Study design oral 90day source substance:
Groups of twelve male and twelve female Alpk:APfSD (Wistar-derived) rats were fed diets containing 0 (control), 65 ,650 or 6500 ppm Aquapel® 364 for at least 90 consecutive days. Clinical observations, bodyweights and food consumption were measured throughout the study. An ophthalmoscopic examination was performed on all animals pre-study and on the control and 6500ppm group in week 12. A functional observation battery, including clinical assessments, measurements of grip strength, time to tail flick, landing foot splay and motor activity were conducted during the last week of the study. Urine samples collected during week 13 were analysed. At the end of the study, the rats were killed and examined post mortem. Cardiac blood samples were taken for clinical pathology, selected organs were weighed and specified tissues were taken for histopathological examination.
Results:
Administration of Aquapel® 364 in the diet at 6500ppm resulted in a reduction in bodyweights from weeks 8 and 6 in males and females respectively. Food consumption and utilisation were reduced in both sexes. Red blood cell parameters were reduced and white blood cell counts, alkaline phosphatase, gamma-glutamyl transferase, alanine aminotrans ferase and asp artate aminotrans ferase levels were increased in both sexes and cholesterol was increased in females when compared to controls. Spleen and liver weights were increased in both sexes and kidney weight increased in females. Treatment related inflammatory changes, were observed in a variety of tissues. These changes included foci of
inflammation and histiocytosis. At an administration level of 650ppm Aquapel® 364 in the diet there were similar findings, but of lesser extent to the 6500ppm dose group. In females, a number of red blood cell parameters were reduced and white blood cell counts, cholesterol levels and liver, spleen and kidney weights were increased. In both sexes, there was an increase in alanine aminotransferase, aspartate aminotransferase levels. In males, there were reductions in bodyweight, food consumption and food utilisation in some weeks. Inflammation and histiocytosis were seen there but there was a reduction in the incidence and severity of these changes compared to the top dose group. When Aquapel® 364 was administered in the diet at 65ppm there were no changes of biological or toxicological significance when compared to the controls.
Conclusion:
Oral administration of Aquapel® 364 at dietary levels of 6500 and 650 ppm for at least 90 consecutive days resulted in toxicity characterised by lower bodyweights, food consumption and red blood cell parameters and increases in white blood cell counts, liver enzymes changes and spleen and liver weights and inflammation and histiocytosis were seen in a number of tissues. There were no test substance related findings at a dietary level of 65 ppm.
The no observed adverse effect level (NOAEL) for this study was considered to be 65 ppm Aquapel® 364, equivalent to 6.3 and 6.8 mg/kg bodyweight for males and females respectively.
Justification for classification or non-classification
Based on the available study results, the substance does not have to be classified and has no obligatory labelling requirement for STOT according to Regulation (EC) No 1272/2008 and its amendments.
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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