Reaction products of diazotised 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid coupled with resorcinol, subsequently coupled with diazotized 2-amino-4,6-dinitrophenol and diazotized 4-nitrobenzenamine, chelated with iron (3+), sodium potassium salts

Endpoint summary

Description of key information

Short-term toxicity to aquatic invertebrates

EC50 (48 h) = 1.03 mg/l

Toxicity to aquatic algae and cyanobacteria

IC50 (72h) = 3.4 mg/l

Additional information

No studies on "aquatic toxicity" are available for the Target Substance. In order evaluate the invertebrates toxicity endpoint a read-across approach was adopted. Tests on two Similar Substances are available. The similarity between the Target Substance and the Similar Substances is detailed in section 13.

Short-term toxicity to aquatic invertebrates

In the key study the substance (Similar Substance 02) was tested for short-term toxicity on freshwater invertebratesaccording to the guideline OECD 202 (1984) and Royal Decree 363/1995 (BOE no.133 of June 1995).
The freshwater crustacean Daphnia magna has been subjected to the dye at concentrations of: 0.1mg/l, 1 mg/l, 10 mg/l, 100mg/l and 1000 mg/l of active ingredient of that product. The total test duration was 48 hours.
The result obtained in this test indicates that the dye had a nominal value of EC50 (48 h) equal to 1.03 mg/l.

One more study is available on Similar Substance 03. It reported an EC50 (24 h) higher than 500 mg/l. However, it should be noted that the study was conducted only for 24 instead of 48 hours, duration of exposure suggested by the internationally recommended guidelines. The difference in time of exposure is certainly a critical effect, especially when assessing exposure to an invertebrate organism with a relative short life-cycle such as Daphnia. Furthermore, considering the potentially highly variable ecotoxicological profile of dye substances, the present deviation was considered to be a significant deficiency. Therefore, the result of the test was disregarded.

Toxicity to aquatic algae and cyanobacteria

In the key study the Similar Substance 02 was tested for acute toxicity on algae according to the OECD Guideline 201 (1984) and Royal Decree 363/1995 (BOE no. 133 of June 1995).

For determination of cell growth inhibition freshwater of Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum) was used. The result obtained in this test indicates that the dye had an IC 50 value (72h) equal to 3.4 mg/l of active material (nominal).

Two tests are available on the Similar Substance 03 and were conducted according to EEC 79/831 Annex V. The EC50 (cell number) for the tested samples under the experimental conditions is extrapolated to 80.8 mg/l and 71.8 mg/l.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment when the following criteria are met:

A )Acute (short-term) aquatic hazard

Category Acute 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

B) Long-term aquatic hazard

(iii) Substances for which adequate chronic toxicity data are not availableand the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 1:96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

Category Chronic 2: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants)> 1 to ≤10 mg/l

Category Chronic 3:96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l

Based on the above results, the test substance has been classified as Aquatic Chronic 2 (H411).