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:
no potential for bioaccumulation

Additional information

PNECs for freshwater and marine water have not been derived. No toxicity was observed in acute toxicity studies conducted in fish, daphnia and algae, at the highest test concentrations used in the studies. The No Observed Effect Levels were therefore the highest test concentrations used. In a Daphnia reproduction study, no significant mortalities and no significant impairment of reproduction were observed at any tested concentration. The measured concentration of test substance in the test solutions indicates that there will be no toxicity at the limit of the substances water solubility.

It is therefore considered that no hazard has been identified for the aquatic environment and therefore that PNECs are not necessary to be derived.

PNECs for sediments and soils have not been derived, as no test data is available on either sediment or soil organisms. As PNECs have not been derived for the aquatic environment, PNEC derivation for soil and sediment has not been performed using the equilibrium partitioning coefficient method.

In addition, all toxicity testing was conducted using water accommodated fractions (WAFs) due to the poor solubility of the test substance constituents. Derivation of PNECs from studies conducted using WAF’s are not generally considered to be reliable as any toxicity if observed could not be attributed to a single component but to the test item as a whole.Therefore, any PNECs derived from studies conducted on complex substance, with a mix of poorly soluble components, should be treated with caution as differences between components in partitioning in the environment could make comparison of a single PNEC to PEC unreliable.

Conclusion on classification

The substance environmental classification is based on the results of acute toxicity test and a chronic study (Daphnia reproduction study).

The acute toxicity testing gave the following results:

Acute Fish: LL50 >100 mg/L loading rate WAF

Acute Daphnia: EL50 >320 mg/L loading rate WAF

Algal Inhibition: EL50 (growth rate) > 100 mg/L loading rate WAF

The Daphnia Reproduction study gave the following resut:

NOELR (immobilization and reproduction): 320 mg/L

No toxicity was observed in any test.

The above results therefore mean the substance does not meet the criteria for environmental classification as Acute Category 1 or Chronic Category 1, 2 or 3.

The substance does not meet the criteria for classification in Chronic Category 4, as although it is poorly water soluble and has constituents with high log Pow values, the substance is readily biodegradable.

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