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EC number: 430-380-7 | CAS number: 445409-27-8
- 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
Neurotoxicity
Administrative data
Description of key information
In an OECD TG 416, 10 male and 10 females from each dose group were evaluated for functional, behavioural and sensory observations. There were no treatment-related changes.
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Link to relevant study records
- Endpoint:
- neurotoxicity: oral
- Remarks:
- developmental
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline under GLP conditions - satellite group as part of two generation reproduction study in the rat.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 416 - satellite group
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of the test substance in the dietary admixtures was determined by high performance liquid chromatography mass selective (HPLC/MS) using an external standard technique.
- Frequency of treatment:
- Daily in diet
- Remarks:
- Doses / Concentrations:
3000, 6000 and 12000 ppp (250, 500 and 1000 mg/kg, respectively)
Basis:
nominal in diet - No. of animals per sex per dose:
- 10 animals of either sex per dose
- Control animals:
- yes, plain diet
- Details on study design:
- During week 10, extensive functional observations and opthalmoscopic examinations were performed on ten selected animals of either sex from each dose group, together with haematology and blood chemistry assessment. The animals were not fasted before sampling.
The ten selected F0 males and ten F0 females from each treatment and control group were observed for signs of functional/behavioural toxicity once weekly.
During week 10, the ten F0 selected animals were assessed for sensory reactivity to auditory, visual and proprioceptive stimuli, grip strength and motor activity.
See reproductive toxicity summary for additional details on reproductive parameters. - Neurobehavioural examinations performed and frequency:
- Once weekly
- Behaviour (functional findings):
- no effects observed
- Details on results:
- There were no treatment related effects in the functional performance parameters measured for the F0 generation animals. There were no treatment related effects in behavioural parameters measured for the F0 generation. There were no treatment related effects in the sensory reactivity parameters measured for the selected F0 generation animals.
Behavioural assessment: All inter and intra group differences in urination, defection and transfer arousal scores were considered to be a result of normal variation for rats of the strain and age used and were of no toxicological importance.
Hunched posture was evident in 12000 ppm (1000 mg/kg) females during Weeks 4, 5 and 6 assessments, however in isolation this finding was considered of no toxicological importance. - Dose descriptor:
- NOEL
- Effect level:
- 12 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Highest dose tested (1000 mg/kg)
- Remarks on result:
- other: Generation: maternal (migrated information)
- Conclusions:
- In an OECD TG 416, 10 male and 10 females from each dose group were evaluated for functional, behavioural and sensory observations. No treatment-related changes were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
Neurotoxicity:
Key study
In an OECD 416 study conducted under GLP conditions, on male and female Sprague-Dawley rats, the NOEL for neurotoxicity related effects of Molyvan 855 is 1000 mg/kg b. w.
Justification for selection of effect on neurotoxicity via oral route endpoint:
Well conducted study in accordance with OECD Guideline and GLP.
Justification for classification or non-classification
Neurotoxicity:
According to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Molyvan 855 is not classified for Neurotoxicity.
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