Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

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

Additional information

As the test material is a UVCB substance, toxicity cannot be contributed to any one constituent and any PNEC derived must be based on the nominal EC50 and NOEC values derived using Water Accommodated Fractions (WAF).

The hazard assessment conclusion for secondary poisoning (PNECoral) is 6.67 mg/kg food.However,the substance has a low potential to bioaccumulate, secondary poisoning is unlikely to occur, and in accordance with Annex IX, Section 9.3.2, Column 2 of REACH, testing need not be conducted. According to the mammalian toxicity data presented this substance is not classified as systemically toxic to mammals and has no other relevant classifications with respect to mammalian toxicity (i.e. it is not a carcinogen, mutagen or reproductive/developmental toxin). According to ECHA Guidance on information requirements and chemical safety assessment Chapter R.16: Environmental Exposure Estimation, an assessment of secondary poisoning only becomes necessary when a substance exhibits potential to cause toxic effects if accumulated in higher organisms and the substance is classified on the basis of relevant mammalian toxicity data.  Since the test item is considered not to exhibit bioaccumulation potential and does not meet relevant classification criteria, a risk assessment covering secondary poisoning is not required. Furthermore, indirect exposure of humans to the substance via the environment can be excluded because significant release from the place of formulation or use is not anticipated (see details of ATIEL-ATC SpERCs).

Conclusion on classification

The test item exhibits no toxicity to fish or Daphnia at the maximum concentration of 100 mg/L WAF and statistical evidence of toxicity in algae at 100 mg/L WAF is considered to be the result of surfactant molecules surrounding the relatively small number of algae that are in solution and reducing their capacity to take up minerals. This effect occurs at a loading rate much higher than the experimentally determined water solubility, and is unlikely to be seen in the environment. As such, the EC50 values are higher than the range specified for classification as Aquatic Chronic 3 under the terms of Regulation (EC) No 1272/2008 even though the substance is not readily biodegradable and Log10 Kow is > 4. In the absence of true aquatic toxicity and with EC 50 values > 100 mg/L classification is not required.