Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

In order to determine the classification for hazardous properties related to the aquatic environment, the criteria of the Regulation (EC) No 1272/2008 (CLP) version 2018 in Annex I were accurately followed.

Short-term (acute) aquatic hazard:

For classification, acute toxicity data are available for fish, aquatic invertebrates (Daphnia) and algae:

Fish: LC50 (96h) > 28 mg/L (based on measured TOC concentrations)

Daphnia: EC0 (48h) > 47 mg/L (based on measured TOC concentrations)

Algae: EC50 (72h, growth rate) = 35.1 mg/L (based on measured TOC concentrations)

The criteria in Table 4.1.0 (a) of Annex I of the CLP Regulation were applied.

The lowest LC50 or EC50 value was observed for Algae, which is hence the most sensitive species. According to Table 4.1.0 (a) the substance should not be classified for acute aquatic hazard, as the lowest EC50 value, EC50 (72h, growth rate) for Algae is 35.1 mg/L, which is above the cut-off for classification of 1 mg/L.

Long-term (chronic) aquatic hazard:

For chronic classification, there are only chronic data available for one trophic level, algae. As described in Figure 4.1.1 in the CLP regulation (EC No 1272/2008, version 2018), the most stringent outcome of classification according to Table 4.1.0 (b) (i) or (ii) and (iii) should be used.

Table 4.1.0 (b) (i):

The substance is not readily biodegradable, hence Table 4.1.0 (b) (i) applies.

No EC10 value could be determined in the algae study. Therefore, the NOEC has been used instead. The NOEC (72h, growth rate) for algae was 15.3 mg/L (measured TOC concentration), which is above the cut-off values for classification (1 mg/L). Therefore, the substance should not be classified for chronic aquatic toxicity.

Table 4.1.0 (b) (iii):

Classification based on available acute data available for 3 trophic levels and environmental fate data:

Fish: LC50 (96h) > 28 mg/L (based on measured TOC concentrations)

Daphnia: EC50 (48h) > 47 mg/L (based on measured TOC concentrations)

Algae: EC50 (72h, growth rate) = 35.1 mg/L (based on measured TOC concentrations)

Log Kow = not available

The substance is not readily biodegradable.

Based on the criteria Table 4.1.0 (b) (iii), the substance should be classified as chronic aquatic toxic, category 3 since the lowest EC50 value for algae is ≤ 10 and < 100 mg/L and the substance is not readily biodegradable.

Most stringent chronic classification:

The conclusion of both assessment is that the substance should be classified for chronic aquatic hazard, category 3.