Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Two study reports (rated as Klimisch 1) on aquatic organisms are available covering two trophic levels: a primary producer (freshwater algae, represented by the model species Pseudokirchneriella subcapitata), and a primary consumer (aquatic invertebrates, represented by the model species Daphnia magna. All tests were conducted following OECD test protocols fulfilling OECD GLP requirements.

The most sensitive effect value was derived in the Acute Toxicity Test to Daphnia magna in a Semi-Static 48-hour Immobilisation Test (Siche 2019) resulting in an EC50 of 0.705 mg/L.

Based on this value according to CLP regulation (EC) 1272/2008, Annex I, Table 4.1.0. (a) and (b) (iii) the test item is classified as hazardous to the aquatic environment in the following categories:

- Aquatic Acute 1 (H400)

- Aquatic Chronic 1 (H410).

The multiplying factors (M-factors) are assigned according to CLP regulation (EC) 1272/2008, Annex I, Table 4.1.3 as following:

M-factor acute = 1, based on the EC50 of 0.705 mg/L.

M-factor chronic = 1, equaling M-factor acute.

As chronic data is not available and Table 4.1.0 (a)(b, point iii) from the CLP regulation “is used for defining long-term aquatic hazard, the resulting M-factor derived for acute aquatic hazard classification is also applied to the long-term aquatic hazard classification.” Guidance on the Application of the CLP Criteria; Version 5.0 – July 2017, p. 509.