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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
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:
read-across: supporting information
Reason / purpose:
read-across source
Test organisms (species):
Daphnia magna
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
21 d
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
3.1 µg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks:
parental survival
Conclusions:
Based on read-across, the 21 d EC10 of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid in Daphnia magna is 3.1 µg a.i./L (parental survival).

Description of key information

21 d EC10 = 3.1 µg a.i./L; Daphnia magna, OECD guideline 211, GLP

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
3.1 µg/L

Additional information

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

The influence of DOPA-Glycinate (20% a.i., as manufactured) on the reproduction of Daphnia magna was investigated. A 21-day semi-static exposure to the test item at nominal concentrations of 0.92, 2.30, 5.75, 14.40, and 36.00 µg a.i./L, with daily renewal of the test solutions was conducted according to OECD guideline 211. Untreated control replicates were run in parallel. Each treatment group consisted of 10 replicates with one daphnid each (individual exposure). Effects on growth (adult length at test termination) and reproductive performance were investigated. Samples of fresh and aged test solutions were analysed for test item concentrations.

Since the nominal concentrations varied by more than 20 %, the biological effects were re-evaluated based on mean measured concentrations. Due to a decrease of test item concentration during the renewal period, the time weighted mean values (TWM) for each treatment level were calculated. The respective TWM were 0.78, 2.28, 2.39, 11.35, and 27.48 µg a.i./L (85.3, 99.2, 41.5, 78.8, and 76.3 % of nominal).

All effect concentrations are given as time weighted mean concentrations:

The 21 d NOEC was 2.3 µg a.i./L (cumulative offspring per Daphnia, intrinsic rate of increase), the EC10 was 3.1 µg a.i/L (parental survival).

 

Concentration

Parental survival

Growth (length on day 21)

Age at first brood

Cumulative offspring per female

Intrinsic rate of increase

EC50
(95% CL)

10.6
(6.5–17.1)

n.d.
(n.d.)

> 27.5
(n.d.)

24.6
(11.3–>27.5)

> 27.5
(n.d.)

EC20
(95% CL)

4.7
(2.8–8.2)

n.d.
(n.d.)

> 27.5
(n.d.)

6.8
(0–14.0)

11.5
(7.4–16.2)

EC10
(95% CL)

3.1
(1.6–6.0)

n.d.
(n.d.)

24.2
(n.d.)

3.4
(n.d.–8.5)

4.4
(1.7–7.0)

NOEC

2.4

≥ 27.5

≥ 27.5

2.3

2.3