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EC number: 601-779-5 | CAS number: 121451-02-3
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Noviflumuron
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Noviflumuron
- PBT status:
- the substance is PBT / vPvB
- Justification:
P CRITERIA
The substance is not readily biodegradable (0.2 to 4 % after 29 days in an OECD 301 B Test) and as such the substance is considered to fulfil the P-screening criteria. In addition, degradation under aerobic conditions was also investigated in three soils (two silt loams and one silty clay loam) according to US EPA 162-1 and 163-1 Guideline. Two metabolites were observed (amine at ca. 13.9 % and urea at ca.9 %), however no degradation rates were calculated. The half-life of the parent substance ranged from 267 to 315 days (at 25 °C) and 755 to 891 days (at 12 °C). Therefore the substance can be considered to fulfil the vP-criterion according to Annex XIII (vP fulfilled if half-life in soil is > 180 days).
B CRITERIA
Screening Data
The log Kow was determined to be 4.94, which is above the screening criteria indicated in Annex XIII (B fulfilled with log Kow of ≥ 4.5) and as such the substance fulfils the screening criteria.
Other Supporting Information
No measured data is available, but EPISUITE (BCFBAF v3.01) estimated a BCF of 857.1 L/kg wwt (regression method) and a BCF of 2129 L/kg wwt (Arnot Gobas method).
Usually the regression method is the most common, however as there is a contradiction between the results, the value based on the Arnot Gobas method would fulfil the B-criterion (>2000); therefore in the absence of any experimental data the substance has to be considered as fulfilling the B-criterion (log kow > 4.5 and BCF > 2000). Further information would be required to show that the substance is not bioaccumulative.
T CRITERIA
Short Term Aquatic Toxicity
The lowest L/EC50s value was taken from a 48 h study conducted in Daphnia magna: 311 ng/L (3.11E-04 mg/L). This value shows that the T-screening criteria (T screening criteria met with L/EC50 <0.1 mg/L) as outlined in the ‘Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT Assessment’ is met.
Long Term Aquatic Toxicity
In addition, the lowest NOEC available is from a chronic Daphnia test: 1.8E-05 mg/L (reproduction), confirming that the substance does fulfil the T-screening criterion included in Annex XIII (T fulfilled if NOEC is < 0.01 mg/L).
Therefore it can be concluded that the substance does fulfil the T-criterion.
Human Health
The substance is classified as carcinogenic Category 2 and toxic for reproduction Category 2.
With regard to the Human Health classification it should be noted that the substance is not classified as carcinogenic (category 1A or 1B) or mutagenic (category 1A or 1B), and there is no other evidence of chronic toxicity, as identified by the classifications: STOT RE category 1 or 2 according to Directive 1272/2008.
Conclusion
Based on the available aquatic toxicity (short and long term) information and human health toxicological information, it can be concluded that the substance does fulfil the T-criterion.
- Likely routes of exposure:
The substance is manufactured under conditions expected to minimise exposure to workers and the environment and so there are no likely routes of exposure. Exposure to the general public is not anticipated to occur as there are minimal releases from the manufacturing process and the substance is exported from the EU following manufacture
Reference
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.