Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

LC50 (96h) in fish > 100 mg/l

EC50 (48h) in crustacea > 100 mg/l

Additional information

Adequate chronic toxicity data is not available; Fluorescent Brightener 002 is not readily biodegradable, is practically not soluble and has a high partition coefficient.

On the basis of the available studies, no L(E)C50 value was recorded in none of the experiments conducted, up to the highest concentration reached in the tests.

According to the CLP Regulation (EC 1272/2008), classification for aquatic toxicity is as follows:

(a) acute (short-term) aquatic hazard - category acute 1:

96 hr LC 50 (for fish) ≤ 1 mg/l and/or

48 hr EC 50 (for crustacea) ≤ 1 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l.

(b) long-term aquatic hazard of substances for which adequate chronic toxicity data are not available

Category chronic 1:

96 hr LC 50 (for fish) ≤ 1 mg/l and/or

48 hr EC 50 (for crustacea) ≤ 1 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l.

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

Category chronic 2:

96 hr LC 50 (for fish) > 1 to ≤10 mg/l and/or

48 hr EC 50 (for crustacea) > 1 to ≤10 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) > 1 to ≤10 mg/l

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

Category chronic 3:

96 hr LC 50 (for fish) > 10 to ≤ 100 mg/l and/or

48 hr EC 50 (for crustacea) > 10 to ≤ 100 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l.

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

‘Safety net’ classification

Category chronic 4

Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a logPow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment.

Based on experimental data on fish and crustacea, no toxicity is seen up to solubility limits, corresponding to nominal values of 100 mg/l or above. Accordingly, no classification for acute or chronic aquatic toxicity is required.

However, a 'safety net' classification H413 is applied as the substance is poorly soluble, not rapidly degradable and have a logPow ≥ 4.