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EC number: 262-810-2 | CAS number: 61477-95-0
- 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
Key value for chemical safety assessment
- Toxic effect type:
- concentration-driven
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 20 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Organ:
- kidney
- liver
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
No data on toxicity after repested exposure is available for Monalazone Disodium. Read-across data is used to fulfill information requirement for this endpoint. Read-across justification is attached in the CSR Appendix I.
Chloramine B trihydrate was then tested in a key 90-day oral gavage toxicity study at dose levels 20, 60, 180 mg/kg bw/day (Valásková, 2007a). There was no mortality nor any significant change in functional (behavioural) and ophthalmological observations. The test substance caused reversible decrease in body weight increments in both sexes (more marked in males) in all dose levels. It was connected with reversible decrease of food consumption and food conversion in both sexes. Reversible changes of health status (piloerection) and clinical changes immediately after application (excited behavior) were recorded in both sexes of the highest dose level. Haematological examination showed an effect on leukocyte differential count in both sexes without dependence on dose level. Portion of lymphocytes was increased and portion of monocytes and granulocytes was decreased. In females of the highest dose level also the increase of number of leucocytes and platelets was observed. During biochemical examination of blood the statistically significant changes were detected at the highest dose level: increased value of urea in both sexes, increased value of chloride ions in males, decreased value of AST, creatinine and potassium ions in males, increased value of bilirubin and ALT in females and decreased value of creatinine and sodium ions in females. Increase of bilirubin was irreversible. Statistically significantly decreased volume of urine was detected in males especially at highest dose level. It was connected with increase of specific gravity of urine. Increased value of pH of urine was recorded in satellite males of the dose level 180 mg/kg bw/day and females of the dose levels 60 and 180 mg/kg bw/day. Decreased volume of urine accompanied by higher specific gravity of urine occurred also in females of the dose level 180 mg/kg bw/day. Statistically significant changes in liver and kidney weight at the (middle and) the highest dose in males and females, which were not or only partly reversible after the recovery phase. In males, this was accompanied by change of colour, however only after the dosing phase and not after the recovery phase.
The most important histological affections were diagnosed in kidneys of males of the (mid and) highest dose level –hyaline droplets in renal tubules and mesangial cell proliferation in renal glomeruli. In the same treated group also the increase of incidence of histiocytosis of lymph nodes and involution of thymus was registered. In females the increased incidence of hydrometra (uterus) was found in all treated groups irrespective of dose level. The LOAEL (Lowest Observed Adverse Effect Level) for males and females was established as 60 mg/kg bw/day. The NOAEL (No Observed Adverse Effect Level) for males and females is 20 mg/kg bw/day.
In conclusion, liver and kidney were retained as target organs due to relevant changes at the highest dose level of 180 mg/kg bw. The other changes at the same dose level and changes at 60 mg/kg were not considered adverse or significant, therefore no changes need to be classified.
Justification for classification or non-classification
Based on the data on the read-across substance there is no need to classify the substance in accordance with the criteria of CLP Regulation 1272/2008.
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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