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Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Remarks:
The long-term toxicity to fish is a standard information requirement for annex IX registrations. It is therefore proposed to perform a long-term fish test according to OECD TG 210 in agreement with OECD guidance 23 (2019) with AAI-DETA (EC no. 629-715-1)
Study period:
Q2-3 in 2024
Justification for type of information:
AAI-DETA (EC no. 629-715-1; CAS no. 1226892-43-8)

Justification for type of information
TESTING PROPOSAL ON LONG-TERM TOXICITY TO FISH

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
The test will be performed with Fatty acids, C18 (unsaturated), reaction products with diethylenetriamine (EC no. 629-715-1; CAS no. 1226892-43-8).
- Name of the substance for which the testing proposal will be used: The testing proposal is intended
to be used for the tested substance, Fatty acids, C18 (unsaturated), reaction products with diethylenetriamine.
In addition, the results may serve as read-across data endpoint for two other AmidoAmines/ imidazoline substances for which already draft decisions were issued: Fatty acids C18 unsat, reaction products with tetraethylenepentamine (AAI-TEPA; EC number: 629-725-6) and Amides, fatty acids C18 unsat, reaction products with polyethylene amines ((AAI-PEHA; EC number: 629-735-0).
Whether the test substance is indeed a suitable source substance for read across will depend on whether the read across hypothesis is true i.e. that there besides to the structurally similarity and similar fate properties of the substances, there is evidence from bridging studies of comparable design and duration for the AAI-DETA Substance and for the target substances.


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP/non-GLP studies: Neither GLP nor non-GLP studies are available investigating the
long-term toxicity of Fatty acids, C18 (unsaturated), reaction products with diethylenetriamine to fish.
- Historical human data: not applicable
- (Q)SAR: No valid QSAR methods able to reliably estimate the long-term toxicity to fish are available AmidoAmines/Imidazoline surfactants.
- In vitro methods: No respective in vitro methods are available.
- Weight of evidence: The currently available data were considered inadequate to serve as basis for a Weight of evidence approach.
- Grouping and read-across: In addition, the result of the long-term fish test may be used in a read-across approach for the other two AmidoAmines/Imidazolines.
It is expected that the test result will confirm our assumption that fish are also on a long-term less sensitive when compared to algae
- Approaches in addition to above: none
- Other reasons: none

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (A
ND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE
THE NECESSARY INFORMATION:
Experimental data about the long-term toxicity of AAI-DETA to fish is needed for the hazard assessment due to the environmental behavior (difficult substance, not-readily biodegradable) and the intrinsic toxicity observed in the algae and long-term daphnia test.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED
IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The endpoint is a standard information requirement and because there are no acceptable alternatives available (adaptations according to REACH Annex XI) we propose to perform a long-term fish test according to OECD TG 210.
The Substance is difficult to test due to the adsorptive, ionisable and surface active properties as explained above and therefore during testing the OECD GD 23 will be followed as far as technically possible.

Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
GLP compliance:
yes

Description of key information

The long-term fish test is a standard information requirement according to Annex IX registrations a long-term toxicity to fish test according to OECD 210 has been proposed.

Key value for chemical safety assessment

Additional information

The long-term fish test is a standard information requirement according to Annex IX registrations therefore a long-term toxicity to fish test according to OECD 210 has been proposed.