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. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states 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 representative source substances to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.

Environmental fate and pathways

Biodegradation

Readily biodegradable (85.2% in 28 d, OECD 301 B); read-across

Bioaccumulation

Log Kow ≥ 2.829 (at 24.8°C, OECD 107)

 

Aquatic acute toxicity

Aquatic invertebrates

EC50 (48 h) = 0.588 mg a.i./L (geometric mean measured, OECD 202, D. magna)

Algae

ErC50 (72 h) = 12.9 mg a.i./L (TWA, OECD 201, P. subcapitata)

 

Aquatic chronic toxicity

Algae

NOErC (72 h) = 0.63 mg a.i./L (TWA, OECD 201, P. subcapitata)

 

Classification according to CLP

Based on the available data listed above, the most sensitive acute effect concentration was obtained for aquatic invertebrates, with an EC50 (48 h) of 0.588 mg a.i./L (geometric mean measured). Thus, the substance needs to be classified as environmental hazard Category Acute 1, according to the consolidated version of Regulation (EC) No 1272/2008 (dated: 01.01.2017) and following amendments (ATPs).

M-factor for acute aquatic toxicity: 1.

The NOErC (72 h) of 0.63 mg a.i./L (TWA) for algae is the only chronic aquatic effect concentration available. In addition, the substance is readily biodegradable and has a log Kow of ≥ 2.829. Therefore, the substance is classified and labelled as long-term aquatic hazard Category Chronic 1, according to the consolidated version of Regulation (EC) No. 1272/2008 (dated: 01.01.2017) and following amendments (ATPs).

M-factor for chronic aquatic toxicity: not applicable.