Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data available: testing technically not feasible

Marine water

Hazard assessment conclusion:
no data available: testing technically not feasible

STP

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (freshwater)

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (marine water)

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.7 mg/kg food
Assessment factor:
300

Additional information

See rationale and discussion in the attached document.

Conclusion on classification

The available toxicity values for Daphnia, Algae and Fish (EL50/LC50: 37 – 550 mg/L), which have been  based on a Water Accommodated Fraction approach due to the extremely low water solubility of the FLL Substances indicates that the substances were well above their solubility limit at the loading values. This allows inference that ecotoxicity would not be expected at the limit of water solubility for any of the FLL Substances.

 

Comparison of the available toxicity values to the T screening criterion from Chapter R.11 of ECHA Guidance (ECHA, 2008d) for acute tests of 0.1 mg/L results in screening conclusion of “presumably not T” for the FLL Substances. Due to difficulties in testing, it is generally expected that chronic fish toxicity data would not be available for similar highly hydrophobic substances, or where available, would be based on a WAF approach with similar uncertainty to the testing data identified above. Therefore, other evidence was considered including: 

  • For the algal tests described above, the chronic 72h no observed effect loadings ranged from 10 to 100 mg/L, which is far above the definitive chronic NOEC criterion of 0.01 mg/L.
  • Very low acute or chronic mammalian toxicity was observed in testing of two representative substances in the FLL Substances (subacute NOAEL>1000mg/kg bw/d; acute NOAEL>2000 mg/kg bw/d for oral and dermal tests) indicating low systemic toxicity in vertebrates.

These considerations were deemed to provide sufficient evidence that toxicity will not occur in a chronic test, allowing for a weight of evidence conclusion of “not T” for the FLL Substances according to the REACH T Criteria and applicable guidance.

 

The FLL Substances also do warrant classification as “hazardous to the aquatic environment” under the European CLP Regulation. Although one of the EL50 results (37 mg/L for algae), could trigger Category 3 of the regulation, this classification is mitigated by the rapid biodegradation of the FLL Substances. 

 

Although toxicity values are not available for terrestrial organisms, it is concluded that testing for terrestrial organisms can be waived because the FLL Substances will not be directly applied to soil and an indirect exposure to soil via sewage sludge transfer is unlikely since the substances biodegrade rapidly, limiting concentrations in sewage sludge. If small amounts of FLL Substances are present in sewage sludge transferred to soils, the substances would have low bioavailability due to a high degree of sorption to soil organic carbon, and would biodegrade further, limiting exposure by terrestrial plants, invertebrates and microorganisms.