Reaction mass of tetrasodium (E)-7-((4-(4-chloro-6-(3-(2-(sulfooxy)ethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenyl)diazenyl)naphthalene-1,3,6-trisulfonate and (E)-7-((4-(4-chloro-6-(3-(2-(sulfooxy)ethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenyl)diazenyl)naphthalene-1,3,6-trisulfonic acid

Endpoint summary

Description of key information

Short-term toxicity to aquatic invertebrates

EC50  > 1000 mg/L

Toxicity to aquatic algae and cyanobacteria

ErC50 > 101.0 mg/l

Additional information

Short-term toxicity to aquatic invertebrates

There are no experimental available data of the target substance, thus the information on the Similar Substance 04 has been taken into account. The structural differences occurring between the target substance and Similar Substance 03 are not expected to significantly impact the toxicity to aquatic invertebrates, thus the read across approach can be considered as representavive and appropriate (details in the document attached to the IUCLID section 13).

The study on acute toxicity to daphnids with the structural analogue meets the requirements of EEC Directive 79/831 Annex V Methods for the determination of ecotoxicity 5.1.2 Acute toxicity for daphnia and the OECD Guidelines for Testing of Chemicals, Section 2 - Effects on biotic systems 202 Daphnia sp., 14-day reproduction test (including an acute immobilisation test). Study conducted in compliance with GLP.

Testing for acute toxicity in Daphnia magna (water flea) over a total of 48 hours yielded the following immobility values:

 

	after 24 hours (mg/L)	after 48 hours (mg/L)
EC0	≥ 1000	560
EC50	> 1000	> 1000

The concentrations tested were 0, 560, and 1000 mg/L. Immobility was observed at 1000 mg/L.

The test batches were present as red solutions. No segregation or formation of precipitates could be observed. 

In order to determine the substance concentration, water samples were taken at the end of the study. All mean values were above 80 % of the nominal concentration.

Toxicity to aquatic algae and cyanobacteria

There are no experimental available data of the target substance, thus the information on the Similar Substance 05 has been taken into account. The structural differences occurring between the target substance and Similar Substance 04 are not expected to significantly impact the toxicity to aquatic algae, thus the read across approach can be considered as representavive and appropriate (details in the document attached to the IUCLID section 13).

Study conducted to test guidance "Algal growth inhibition test" Council Directive (1992) in compliance with GLP.

Exponentially-growing cultures of a species of green algae are exposed to various concentrations of the test substance over several generations under defined conditions.

The test solutions are incubated for a period of 72 hours, during which the cell density in each is measured at every 24 hours. The growth inhibition and growth rate in relation to a control is determined after 72 hours of incubation.

The test results refer to a concentration of the test substance, which was calculated directly from analytically determined TOC values. According to the relevant product information, 1 mg/L TOC equals to 2.9 mg/L of the main component of the test substance (molecular weight: 859 g/mol).

No toxic effects against algae at 101.4 mg/L were noted on the substance tested. 

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 (fish toxicity) when the following criteria are met:

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

(iii) 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 log K ow ≥ 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 (Note 2)

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

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 (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log K ow ≥ 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 than the ones provided by any of the methods listed in section 4.1.2.9.5.

The EC50 value, calculated in the toxicity test to Daphnia magna, is greather than 1000 mg/l, therefore the test substance is out of classification. No classification is required even for the toxicity test to Algae, as the ErC50 value is greather than 101 mg/l.

In conclusion the substance is Not Classified for Aquatic toxicity.