Amines, N-C12–14 (even numbered)-alkyltrimethylenedi-, reaction products with chloroacetic acid and diethylenetriamine, N-C12–14 (even numbered)-alkyl derivs.

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish, juvenile growth test

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
- they are manufactured from similar or identical precursors under similar conditions
- they share structural similarities with common functional groups (corresponding to scenario 2 of the read-across assessment framework): both, the target and source substance, are aliphatic amines with C8-18 alkyl chains and acetate functions
- Two thirds (w/w) of the target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (excluding the solvent water) are composed of the source substance DOPA-Glycinate. The remaining third of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid consists of other aliphatic amines and derivatives which are considered as structural analogues to those constituting the source substance DOPA-Glycinate and may therefore be expected to elicit comparable (eco)toxicological effects.

The read-across hypothesis is based on structural similarity of target and source substances. Based on available experimental data, including key physicochemical properties and data from acute toxicity, repeated dose toxicity, genotoxicity and short term ecotoxicity studies, the read-across hypothesis is supported by a quite similar toxicological profile of both substances.

(Eco)toxicological, physicochemical and environmental fate data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.

Therefore, read-across from the existing ecotoxicity, environmental fate and toxicity studies conducted with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

Further details are attached to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
For further details refer to IUCLID section 13.

3. ANALOGUE APPROACH JUSTIFICATION
For further details refer to IUCLID section 13.

4. DATA MATRIX
For further details refer to IUCLID section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

52.3 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

other: Mortality, wet weight, body length, pseudo-specific growth rate

Validity criteria fulfilled:

yes

Conclusions:

Based on read-across, the NOEC of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid in juvenile rainbow trout (Oncorhynchus mykiss) is estimated to be >/= 52.3 μg a.i./L.

Description of key information

NOEC >/= 52.3 µg a.i./L; Oncorhynchus mykiss, OECD guideline 215, GLP

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

52.3 µg/L

Additional information

No experimental data on long-term toxicity to fish are available for the target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid. However, a study was conducted with the closely related source substance DOPA-Glycinate. A justification for read-across is attached to IUCLID section 13.

The effect of DOPA-Glycinate (20% a.i., as manufactured) on growth and survival of juvenile rainbow trout (Oncorhynchus mykiss) was tested according to OECD guideline 215 (2000) at nominal concentrations of 4.7, 9.4, 18.8, 37.5 and 75.0 μg a.i./L under flow-through conditions for 28 days.

At mean measured concentrations up to and including 52.3 μg a.i./L, neither any significant effect nor any trend was observed. The fish grew well (203–223% of start weight) during the test and fulfilled the control validity criteria of the OECD Guideline 215 at all treatment levels. As no effect was observed, the NOEC of the test item related to mean measured concentration was determined to be ≥ 52.3 μg a.i./L.