Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. In Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X”, it is stated that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

A read-across approach was applied to this substance and data was compiled from a representative source substance to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.

Environmental fate and pathways

Hydrolysis

50% recovery after 30 d (pH 9.0) and 40 d (pH 4.6 and 6.9) at 25 °C (OECD 111); read-across

Degradation

Not readily biodegradable (39% ThODNH4/25% ThODNO3); read-across

Bioaccumulation

log Kow = -4.9 at 20 °C (OECD 105, Flask method)

log D = -3.8 to -13.3 (pH 0 - 14, SPARC v4.6)

 

Aquatic acute toxicity

Fish

LC50 (96 h) > 100 mg/L (nominal, OECD 203, D. rerio); read-across

Aquatic invertebrates

EC50 (48 h) > 100 mg/L (nominal, OECD 202, D. magna); read-across

Aquatic algae

ErC50 (72 h) > 100 mg/L (geometric mean measured, OECD 201, P. subcapitata); read-across

Aquatic chronic toxicity

Aquatic algae

ErC10 (72 h) > 100 mg/L (geometric mean measured, OECD 201, P. subcapitata); read-across

 

Conclusion on CLP

Based on the compiled data above, no short-term toxicity to aquatic organisms of all three trophic levels (fish, aquatic invertebrates and algae) was recorded and the respective acute effect concentrations are all clearly above 1 mg/L. Likewise, the single chronic effect concentration for aquatic algae indicates no chronic effects either (ErC10 > 100 mg/L). Furthermore, the substance is not readily biodegradable but has a low potential for bioaccumulation (log Kow = -4.9). Therefore, the substance is not classified and labelled for environmental hazards, according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments.