Registration Dossier

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 exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Data has been obtained from studies conducted with Reaction mass of 2-ethyl-2 -(methoxymethyl)-propane-1,3-diol and 2 -ethylpropane-1,3 –diol.

Aquatic tests covering 3 trophic levels (algae, daphnia, fish) were conducted. The studies were conducted in accordance with GLP and results were based on nominal concentrations. The results of all three studies indicated that the L(E)C50 values were all >2000 mg/L (Fish LC50 = 2,400 mg/L, Daphnia EC50 = 7,060 mg/L, Algal ErC50 = 2,512mg/L).

As the substance is readily biodegradable and as no significant exposure is expected no PNEC for the STP is required. Moreover, the toxicity of the substance to STP microorganisms was derived from the 28 day ready biodegradability study presented in section 5. The average tested concentration of TOC (total organic carbon) in this study was 40.5 mg/L. Subtracting the 3 mg/L TOC contributed by the inoculum suggests that the test material reaction mass of 2-ethyl-2 -(methoxymethyl)-propane-1,3-diol and 2 -ethylpropane-1,3–diol was tested at 37. 5 mg TOC/L. The molecular weight of the test substance is 104.15 with a carbon weight 60.055. This indicates that the test substance is 57.66% carbon. Therefore 37.5 mg TOC/L for reaction mass of 2-ethyl-2 -(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3–diol equates to a total concentration of the test item of 65 mg/L. No inhibition was indicated in the biodegradability study at concentrations expected to be in the range of those present in influent of an STP. As such no risk to STP microorganisms is expected and so a further study to assess the short term toxicity to microbes is not required in accordance with Column 2 of REACH Annex IX.

Conclusion on classification

The test substance demonstrates no signficant toxicity to aquatic organisms. As such no hazards are indentified for the environment and the substance should not be considered harmful to aquatic organisms.

No classification is triggered based on available data, according to EEC Council Directive 79/831/EEC Annex VI, Part II (D) as described in Commission Directive 93/21/EEC or Regulation (EC) No 1272/2008,