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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
Key value for chemical safety assessment
- Toxic effect type:
- concentration-driven
Effects on fertility
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data on reproduction toxicity 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 administered to female rabbits at dose levels of 10, 30 and 90 mg/kg bw/day orally, by gavage from the 6th to 28th day of pregnancy (Hansen, 2011; key study). In addition, a restricted feeding control was employed consisting of untreated dams which were offered the food amount consumed by the high dose dams. Under the present test conditions, the no-observed-effect level (NOEL) was 10 mg/kg bw/day for the dams. Transient slight or moderate reductions were noted for the body weight and food intake of the dams treated with 30 mg /kg bw/day. Distinct reductions of body weight and food consumption, especially during the first days of treatment, were noted at 90 mg/kg bw/day. Similar reductions of body weight and food intake were noted in the untreated dams with restricted feeding. The no-observed-effect level (NOEL) for the fetal organism also was 10 mg/kg bw /day. A dose level of 30 mg/ kg bw /day resulted in increased incidences of total skeletal retardations, in particular sternebra(e) not ossified. The severely materno-toxic dose level of 90 mg/kg bw /day resulted in developmental retardations in the form of reduced placental and fetal body weights compared to the control. Skeletal examination (according to DAWSON) revealed increased fetal incidences for variations of the sternum (fusions) and total skeletal variations as well as retardations of the sternum and lumbar vertebral bodies (incomplete or missing ossification) and total skeletal retardations. No test item related malformations were noted during external, internal or skeletal examination (according to DAWSON) of the fetuses or soft tissue examination of the fetal heads (according to WILSON) at any tested dose level, not even at materno-toxic dose levels. No embryotoxic changes were noted for the restricted feeding group. In conclusion, the test item possessed no teratogenic properties. Chloramine B trihydrate revealed slight embryotoxicity at materno-toxic dose levels (30 or 90 mg/ kg bw/day).
Justification for classification or non-classification
Monalazone Disodium does not need to be classified for reproductive and developmental toxicity according to the CLP regulation (No. 1272/2008).
Additional information
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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