N,N-dimethyl-alkyl-1-amines, reaction products with alkali hydroxide and chloroacetic acid

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
Long-term toxicity testing on fish is a standard requirement for aquatic toxicity according to Annex IX of REACH Regulation. Since N,N-dimethyl-C12-14-(even numbered)-alkyl-1-amines, reaction products with potassium hydroxide and chloroacetic acid (EC 939-682-8) is registered at a volume of >1000 tpa and a data gap has been identified for long-term toxicity to fish, it is proposed to run a fish early-life stage toxicity test according to OECD 210 guideline.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : N,N-dimethyl-C12-14-(even numbered)-alkyl-1-amines, reaction products with potassium hydroxide and chloroacetic acid (EC 939-682-8).

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- GLP / non-GLP studies : no experimental long-term fish toxicity study has ever been performed on the substance EC 939-682-8;
- Historical human/control data : not applicable for this endpoint;
- (Q)SAR : no relevant QSAR model exists to predict the long-term toxicity to fish of surface-active substances such as the substance EC 939-682-8;
- In vitro methods : not applicable for this endpoint;
- Weight of evidence : no data have been identified that could be used in a WoE approach for this endpoint;
- Grouping and read-across : no appropriate long-term fish toxicity data have been found on any relevant alkyl dimethyl betaine analogue; long-term fish toxicity data exist on less closely related cocoamidopropryl betaine substances and were used in the past to fill the datagap identified for the substance EC 939-682-8; it is however expected that ECHA will challenge the robustness of this read-across approach and will request a long-term fish toxicity test to be performed on the substance EC 939-682-8 itself;
- Substance-tailored exposure driven testing: not applicable for this endpoint;
- Approaches in addition to above: not applicable for this endpoint;
- Other reasons: not applicable for this endpoint.

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:
- Column 2 of Section 9.1 of Annex IX was long-time considered as a "trigger" by registrants, i.e. one of the three fish tests listed in Column 1 shall be proposed if the CSA shows it is needed. Based on this interpretation of Column 2 and according to the information available on the substance EC 939-682-8 (long-term toxicity on Daphnia sp., fish species not expected to be more sensitive than aquatic invertebrate species based on short-term toxicity dataset, all risk covered in the CSA), no long-term fish toxicity study has ever been proposed in the past.
- Several cases dealing with the interpretation of Column 2 of Section 9.1 of Annex IX were discussed before the Board of Appeal in 2020-2021 (e.g. case A-011-2018, case A-010-2019). According to the decisions made by the Board of Appeal, long-term toxicity testing on fish is a mandatory requirement for REACH registration dossiers of >100 tpa, unless waived under Annex XI.
- As long-term toxicity testing on fish cannot be waived under Annex XI for the substance EC 939-682-8, it is proposed to run a fish early-life stage toxicity test according to OECD 210 guideline.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: not relevant.

Qualifier:

according to guideline

Guideline:

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

Description of key information

 Long-term toxicity testing on fish is a standard requirement for aquatic toxicity according to Annex IX of REACH Regulation. Since N,N-dimethyl-C12-14-(even numbered)-alkyl-1-amines, reaction products with potassium hydroxide and chloroacetic acid (EC 939-682-8) is registered at a volume of >1000 tpa and a data gap has been identified for long-term toxicity to fish, it is proposed to run a fish early-life stage toxicity test according to OECD 210 guideline. 

Additional information

Column 2 of Section 9.1 of Annex IX was long-time considered as a "trigger" by registrants, i.e. one of the three fish tests listed in Column 1 shall be proposed if the CSA shows it is needed. Based on this interpretation of Column 2 and according to the information available on the substance EC 939-682-8 (long-term toxicity on Daphnia sp. on the analogue substance EC 931-700-2, fish species not expected to be more sensitive than aquatic invertebrate species based on short-term toxicity dataset, all risk covered in the CSA), no long-term fish toxicity study has ever been proposed in the past.

Several cases dealing with the interpretation of Column 2 of Section 9.1 of Annex IX were discussed before the Board of Appeal in 2020-2021 (e.g. case A-011-2018, case A-010-2019). According to the decisions made by the Board of Appeal, long-term toxicity testing on fish is a mandatory requirement for REACH registration dossiers of >100 tpa.

For the record, a long-term fish toxicity data exists on the cocoamidopropryl betaine analogue substance EC 931-700-2 (NOEC = 0.135 mg/L) and was used in the past to fill the datagap identified for the substance EC 939-682-8. It is however expected that ECHA will challenge the robustness of this read-across approach and will request a long-term fish toxicity test to be performed on the substance EC 939-682-8 itself. It is therefore proposed to run a fish early-life stage toxicity test according to OECD 210 guideline on the substance EC 939-682-8. In the meantime, the long-term fish NOEC value of 0.135 mg/L from the cocamidopropyl betaine analogue is used for PNEC derivation.