Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium

Endpoint summary

Description of key information

Short term toxicity to fish: LC50 > 100 mg/L

Short term toxicity to aquatic invertebrates: EC50 > 100 mg/L (mobility)

Long term toxicity to aquatic invertebrates: NOEC > 10 mg/L

Toxicity to aquatic plants other than algae: EC50 > 200 mg/L, EC10 > 12,5 mg/L

Toxicity to microorganisms: EC50 > 1000 mg/L

Additional information

Since no studies are available for the target substance, Similar Substance 1 has been considered to complete the assessment for the aquatic compartment. Justification for Read Across is given in Section 13 of IUCLID.

Similar Substance 1 has been evaluated in toxicity studies for the three trophic levels: fish, aquatic invertebrates and aquatic plants:

 

Short-term toxicity to fish

Similar Substance 1 has been tested in an acute toxicity study according to DIN 38412 on Leuciscus idus L., Golden Variety, using a static procedure. An LC50 (96h) > 100 mg/L has been determined. This study has been considered as key study since method and information on the test material and on the results are well described.

The key study is supported by 2 published studies. Tonogai et al. (1978) reported a median tolerance limit (TLm) test conducted on Similar Substance 1 according to JIS K0102 using Medaka (Oryzias latipes). No information on the purity of the test material has been provided by the authors. An LC0 (48h) = 3000 mg/L was determined. Flury and Flühler (1994) performed a study on Similar Substance 1 using Cyprinus carpio, information on the used method and on study design are not reported. An LC50 (48h) > 100 mg/L value has been published.

Short-term toxicity to aquatic invertebrates

Similar Substance 1 has been tested in a study according to EU Method C.2 on Daphnia magna. The exposition duration is 48 h. No effects occurred up to the highest test concentration of 100 mg/L. Therefore, the EC50 was determined to be > 100 mg/L. Information and details on method and study design makes the result obtained reliable.

The result is supported by citations in Flury and Flühler paper (1994). The study has been performed on Daphnia sp; information on method are not included. Two EC50 values are mentioned: EC50 (48h) > 1000 mg/L and EC50 (3h) > 100 mg/L.

Long-term toxicity to aquatic invertebrates

A long term GLP guideline study according OECD 211 on Daphnia Magna has been conducted on Similar Substance 1. A LOEC > 10 mg/L and a NOEC >= 10 mg/L were determined.

Toxicity to aquatic plants other than algae

A GLP guideline study according OECD 221 has been conducted on Lemna Gibba. A value of ErC10 equal to 12.5 mg/L and an ErC50 > 200 mg/L were determined.

 

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

(i) Non-rapidly degradable substances for which there are adequate chronic toxicity data available:

Category Chronic 1: Chronic NOEC or EC_x(for fish and/or for crustacea and/or for algae or other aquatic plants) ≤ 0.1 mg/L,

Category Chronic2: Chronic NOEC or EC_x(for fish and/or for crustacea and/or for algae or other aquatic plants)> 0.1 to ≤ 1 mg/L;

and according to the test studies reported above, Similar Substance 1 was tested in acute tests with fish, Daphnia and Lemna Gibba. No effects occurred and the LC50/EC50s were determined to be > 100 mg/L. Furthermore, chronic values are available for Daphnia and Lemna Gibba. The NOEC respectively EC10 for both species were determined to be > 10 mg/L and the substance is non-rapidly degradable. Similar substance 1 show no toxicity to the three trophic levels analysed.

As a consequence, using the read across approach, the target substance,Acid Blue 9 ammonium salt, can be assessed in the same way: no toxicity for the aquatic compartment is expected.

 

Toxicity to microorganism

In this section it is also valuable to mention two studies that aim to evaluate the toxicity of Similar Substance 1 to microorganism.

The first one is a deeply described test, in GLP compliance according to OECD 209, cosidered as key study in which the inhibition of oxygen consumption has been measured. Values for EC10, EC20, EC50 and EC80 were determined to be > 1000 mg/L.

The second is a supporting study where the toxicity to microorganisms has been determined according DIN 38412 part 27 using Pseudomonas putida. After 30 min exposure the oxygen consumption has been measured. The EC10, EC50 and EC90 was determined to be above 10000 mg/L.

According to this data, the inhibition of the degradation activity of activated sludge is not anticipated when introduced to biological treatment plants in appropriate low concentrations.

References:

- Flury, M. at al. 1994. Brilliant BIue FCF as a Dye Tracer for Solute Transport Studies - A Toxicological Overview.J. Environ. Qual.23: 1108-1112.

- Tonogai, Y. et al. 1978. Biochemical decomposition of coal tar dyesII. Acute toxicity of coal tar dyes and their decomposed products.J. Toxicol. Sci.3: 205-214.