Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Data on short-term ecotoxicity are available on the substance that, according to QSAR Estimation (EPISUITE, 2017) is considered non ready biodegradable.

According to the CLP Regulation 1272/2008/EC, 4.1.3.3 section, substances can be allocated to one of the aquatic toxicity categories based on the criteria of Table 4.1.0:

a) Acute (short-term) aquatic hazard

Category Acute 1:

< 1 mg/L 96 hr LC50 (for fish) and/or

< 1 mg/L and/or 48 hr EC50 (for crustacea) and/or

< 1 mg/L 72 or 96 hr ErC50 (for algae or other aquatic plants)

b) Long-term aquatic hazard

(iii) Substances for which adequate chronic toxicity data are not available

Category Chronic 1:

< 1 mg/L 96 hr LC50 (for fish) and/or

< 1 mg/L and/or 48 hr EC50 (for crustacea) and/or

< 1 mg/L 72 or 96 hr ErC50 (for algae or other aquatic plants)

Category Chronic 2: 

>1 to ≤10 mg/L 96 hr LC50 (for fish) and/or

>1 to ≤10 mg/L 48 hr EC50 (for crustacea) and/or

>1 to ≤10 mg/L 72 or 96 hr ErC50 (for algae or other aquatic plants)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).

Category Chronic 3: 

>10 to ≤ 100 mg/L 96 hr LC50 (for fish)and/or

>10 to ≤ 100 mg/L 48 hr EC50 (for crustacea) and/or

>10 to ≤ 100 mg/L 72 or 96 hr ErC50 (for algae or other aquatic plants)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).

The short-term ecotoxicity values are available for two throphic levels:

EC50 (48h) invertebrate Daphnia: 103 mg/L

ErC50 (7d) aquatic plants Lemna minor: 313 mg/L (frond number)

ErC50 (7d) aquatic plants Lemna minor: 55.2 mg/L (dry weight)

NOrEC (7d) aquatic plants Lemna minor: 9.55 mg/L (frond number)

NOrEC (7d) aquatic plants Lemna minor: 3.02 mg/L (dry weight)

The algal growth inhibition test of the base-set is, in principle, a multigeneration test. However, for the purposes of applying the appropriate assessment factors, the EC50 is treated as a shorterm toxicity value. The NOEC from this test may be used as an additional NOEC when other long-term data are available. In general, an algal NOEC should not be used unsupported by longterm NOECs of species of other trophic levels (TGD Part II).

According to the OECD221, toxicity estimates should be based on frond number and one additional measurement variable (total frond area, dry weight or fresh weight), because some substances may affect other measurement variables much more than the frond number.  This effect would not be detected by calculating frond number only.

ErC50 based on fron number is 313 mg/L, is out of the CLP regulation n. 1272/2008, limit specification (100 mg/L).

ErC50 (7d) aquatic plants Lemna minor: 55.2 mg/L (dry weight) is between 10 -100 according to the CLP regulation n. 1272/2008, limit specification.

The aquatic toxicity based on the lowest of the available toxicity values is therefore between 10 and 100 mg/L (Lemna 55.2 mg/L).

As conclusion, according to the classification criteria of the CLP regulation n. 1272/2008, the registered substance is classified for the environment as H412, Category Chronic 3.