Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-441-5 | CAS number: 83121-18-0
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.006 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.001 mg/kg sediment dw
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0 mg/kg sediment dw
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.004 mg/kg soil dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 0.67 mg/kg bw
- Assessment factor:
- 3 000
Additional information
The PNEC derivation acc. to EPM was justified as follows:
PNEC freshwater sediment: 0.0162 µg/kg dw
K_(susp-water) = 652.45
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_freshwater sediment= (K_(susp-water)/ RHO_(susp)) * PNEC_freshwater * 1000
PNEC marine water sediment: 0.00112 µg/kg dw
K_(susp-water) = 652.45
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_marine sediment = (K_(susp-water)/ RHO_(susp)) * PNEC_marinewater * 1000
Conclusion on classification
a.s. = active substance = Teflubenzuron
Conclusion on classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
Classification related information
Biodegradability: not readily biodegradable (1% biodegradation after 28 days, OECD 301B)
Biodegradation half-life in freshwater: 29.6 days at 12 °C (entire system)
Half-life for hydrolysis: DT50 = 8.7 days at a temperature of 25 °C and a pH of 9
Log Pow: 4.98 at 20 °C
Aquatic acute toxicity
- Aquatic invertebrates: EC50 (48 h) = 0.0028 mg a.s./L (mean measured, Daphnia magna, OECD 202)
- Algae: ErC50 (96 h) ≥ 0.02 mg a.s./L (nominal, Desmodesmus subspicatus, EU Method C.3)
- Fish: LC50 (96 h) > 0.0065 mg a.s./L. (arithm. mean measured, L. macrochirus, OECD 203)
Aquatic chronic toxicity
- Algae: NOEC (96 h) >= 0.02 mg a.s./L (nominal, Desmodesmus subspicatus, EU Method C.3)
- Aquatic invertebrates: key values for freshwater and marine species are available
Freshwater: NOEC (21 d) = 0.062 µg a.s./L (nominal concentration, Daphnia magna, OECD 211)
Marine water: NOEC (27 d) = 0.043 µg a.s./L (mean measured, Mysidopsis bahia, EPA 540/9-82-024 ASTM Standard E1191-90)
- Fish: NOEC (28 d) > 0.0186 mg a.s./L (arithm. mean measured, Oncorhynchus mykiss, OECD 215)
Conclusion
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Teflubenzuron is not rapidly degraded. The substance was found to be not readily biodegradable. Further, the DT50 for biodegradation in the freshwater phase was determined to be 29.6 days at 12 °C. The DT50 for hydrolysis was measured to be 8.7 days at a temperature of 25 °C and a pH of 9. Following worst case assumption the substance is considered to be not rapidly degraded from aquatic compartments in accordance with the criteria given in section 4.1.2.9.5 in Annex I to Regulation (EC) No 1272/2008 (CLP). The most sensitive short-term test for the aquatic compartment was to aquatic invertebrates with Daphnia magna. The test revealed an EC50 (48 h) of 0.0028 mg a.s./L (mean measured). For the same species the lowest freshwater long-term result was determined: NOEC (21 d) = 0.062 µg a.s./L (nominal concentration, Daphnia magna, OECD 211). For marine species, Mysidopsis bahia was most sensitive with a NOEC (27 d) of 0.043 µg a.s./L (mean measured concentrations). The log Pow was determined to be 4.98. Based on these results, Teflubenzuron is classified for aquatic short-term (acute) toxicity, Category 1 (H400, Very toxic to aquatic life; M = 100) and for aquatic long-term (chronic) toxicity Category 1 (H410, very toxic to aquatic life with long-lasting effects; M = 1000) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.
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.
