Reaction products of tetrazotized 5-amino-2-[(E)-2-(4-amino-2-sulfophenyl)ethenyl]benzenesulfonic acid with 6-amino-4-hydroxynaphthalene-2-sulfonic acid and 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid in 2-[bis(2-hydroxyethyl)amino]ethanol

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON LONG-TERM TOXICITY TO AQUATIC INVERTEBRATES

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Bayscript Blaukomponente TEA (EC No. 916-899-6)
- Name of the substance for which the testing proposal will be used [if different from tested substance]: This substance itself only.

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no GLP studies available for this substance covering the endpoint of long-term toxicity towards aquatic invertebrates.
- Available non-GLP studies: No further studies on aquatic toxicity on aquatic invertebrates are available.
- (Q)SAR: There is no valid (Q)SAR model available to address long-term toxicity towards invertebrates and which outcome would be reliable enough to suffice the information requirements under REACH Annex IX (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter
R. 7a: Endpoint specific guidance).
- Weight of evidence: There is no data available which is sufficient for a weight of evidence approach for the endpoint of long-term toxicity towards invertebrates.
- Grouping and read-across: Grouping and read-across approaches have been evaluated and are not considered in this case.
Overall, the registrant has carefully considered all general adaption procedures as listed in Annex XI of the REACH regulation, however the registrant has come to the conclusion that the lack of available data through studies and the level of extensiveness of the study proposed herein, the conduction of an OECD TG 211 is considered the best course of action in order to elucidate the long-term toxicity towards the aquatic compartment.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
According to REACH Annex IX 9.1.5. ‘Long-term toxicity testing on invertebrates, (unless already provided as part of Annex VIII requirements)’ is a standard information requirement and cannot be generated otherwise. This has been consolidated with reference towards aquatic toxicity in general, also in the most recent Board of Appeal decision, BoA-Case Number: A-011-2018.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: An OECD 211 Guideline Study has been proposed to assess the long-term toxicity towards aquatic invertebrates. The substance is to be applied via the medium.

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

yes (incl. QA statement)

Description of key information

In order to comply with the standard information requirements of Annex IX of REACH at this tonnage level the registrant proposes a study according to OECD Guideline 211 (Daphnia magna Reproduction Test) as best course of action. The study result from this test will be adequate for the purpose of classification and labelling and risk assessment and elucidate the long-term behavior towards the aquatic compartment.