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 2016 in Annex I were accurately followed.

Short-term (acute) aquatic hazard:

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

Fish: average LC50 (48h) = 431.5 mg/L (average of 237 and 626 mg/L)

Daphnia: EC50 (24h) = 888 mg/L

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

The lowest EC50 value was observed for fish, which is hence the most sensitive species. It is important to note that the aquatic toxicity studies were not performed according to the OECD guideline, and that the exposure duration deviates from the standard exposure period. For fish, exposure was 48h instead of the prescribed 96h, and for Daphnia exposure was 24h instead of 48h. Nevertheless, given that the EC50 values are many times higher than the cut-off for classification being 1 mg/L, it is safe to state that according to Table 4.1.0 (a) the substance should not be classified for acute aquatic hazard, as the lowest EC50 value is 237 mg/L, which is well 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 2016), 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 assumed to be not readily biodegradable, hence Table 4.1.0 (b) (i) applies.

The NOEC (8d) was 40 mg/L. Since the NOEC is well above the classification cut-off of 1 mg/L, the substance should not be classified.

Also here it is important to note that the duration of the algae test was 8d which is not in line with the OECD 201 guideline which prescribes 72 or 96h exposure. Nevertheless, it is safe to state that the substance should not be classified given that the NOEC value is 40 times larger than the classification cut-off.

Table 4.1.0 (b) (iii):

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

Fish: average LC50 (48h) = 431.5 mg/L (average of 237 and 626 mg/L)

Daphnia: EC50 (24h) = 888 mg/L

Log Kow = 1.85

The substance is not readily biodegradable.

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

Most stringent chronic classification:

The conclusion of both assessment is that the substance should not be classified for chronic aquatic hazard.