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 fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

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: Acute toxicity studies are available for daphnids, fish and algae. In addition, a daphnia reproduction study is available. There are no GLP-compliant fish early-life stage studies available on the substance.
- Available non-GLP studies: There are no non-GLP-compliant fish early-life stage studies available on the substance.
- Historical human data: Not relevant for this endpoint.
- (Q)SAR: There are no QSAR models available for this higher tier ecotoxicological endpoint that are sufficiently validated and acceptable (according to OECD Q/SAR validation criteria).
- In vitro methods: The registrant is not aware of any validated alternative tests that use in vitro methodologies that could be used to meet the standard requirement of the REACH regulation for fish early-life stage toxicity.
- Weight of evidence: No data are available for use in a weight of evidence approach.
- Grouping and read-across: Grouping and read-across approaches have been evaluated and are not considered in this case.
- Substance-tailored exposure driven testing [if applicable] : Not applicable
- Approaches in addition to above [if applicable] : Not applicable
- Other reasons [if applicable] : Not applicable

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 210: Fish Early Life Stage (FELS) toxicity test is considered the best course of action in order to elucidate the long-term toxicity towards fish of Bayscript Blaukomponente TEA.

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, 9.1.6. ‘Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements)’ is a standard information requirement and cannot be generated otherwise. The Fish Early Life Stage (FELS) toxicity test (OECD TG 210) is regarded as the most suitable test guideline for addressing the information requirements.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:

- Details on study design / methodology proposed [if relevant]: Not relevant

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

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 210 (Fish, Early-Life Stage Toxicity Test) as best course of action. The study result from thise test will be adequate for the purpose of classification and labelling and risk assessment. Furthermore, this will elucidate the long-term behavior towards the aquatic compartment.