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Diss Factsheets

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 and ecotoxicological properties because
• they are manufactured from similar precursors under similar conditions
• they share structural similarities and common functional groups
• the analytical descriptors show comparable results
• the metabolism pathway leads to comparable products (amine backbone and long chain fatty acids) and non-common products predicted to have no toxicological effects (long chain fatty acids).

This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance C1618FA-TEPA-compound are predicted to be similar to those of the source substances Partially unsaturated IQAC, DMS quaternised and oleic acid based IQAC, DMS quaternised.

Based on the available experimental data, the read-across strategy is supported by close structural analogy as well as similar toxicological profiles.

Therefore, read-across from the existing sub-chronic toxicity studies and pre-natal developmental toxicity as well as ecotoxicological studies on the source substance 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.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to detailed Justification for read-across attached to Iuclid section 13

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to detailed Justification for read-across attached to Iuclid section 13

4. DATA MATRIX
Please refer to detailed Justification for read-across attached to Iuclid section 13
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Test organisms (species):
Daphnia magna
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
21 d
Remarks on exposure duration:
per generation
Reference substance (positive control):
no
Key result
Duration:
63 d
Dose descriptor:
NOEC
Effect conc.:
> 100 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction

Description of key information

The 63d NOEC of >100 μg/L was determined in a 21-day-reproduction test with Daphnia magna over 3 generations. Daphnids were exposed to the effluent of the activated sludge unit containing the degradation products of partially unsaturated IQAC, DMS quaternised.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
NOEC
Effect concentration:
100 µg/L

Additional information

Experimental data on long-term toxicity to aquatic invertebrates of C16 18FA-TEPA-compoundare not available. However,  a Daphnia reproduction test was conducted with the structurally related source substance Partially unsaturated IQAC, DMS quaternised. A justification for read-across is attached to Iuclid section 13.


The 21-day-reproduction test of the effluent of a model activated sludge unit fed with 10 mg/L of the closely related substance partially unsaturated IQAC (containing 10% of Isopropanol) to Daphnia magna was studied under static renewal conditions. Daphnidswere exposed to the effluent of the activated sludge unit containing the degradation products of the test item. A control activated sludge unit without the test item was run in parallel. The test duration for every generation was 21 days. Neonates of the 14thtest day were exposed as filial generation under the same conditions as the parental generation. Filial generations 1 and 2 were monitored for reproduction rate, time of the first offspring and parental mortality.


Parental generation: In the parental generation there was no difference between the exposed and the not exposed daphnids, however the first offspring in the controls was one day later. Mortality of the parental generation was slightly higher in the control.


 


F1 generation:


42 days after the start of exposition of parental generation, the reproduction rate of the surfactant exposed F1 generation was enhanced and exceeded that of the control. The mean number of parental daphnids was greater than in the control. There was no difference in the time of appearance of the first offspring. Mortality of the parental generation was slightly higher in the control.


 


F2 generation:


63 days after the start of exposition of the first parental generation, in the second filial generation some adverse effects were observed for the surfactant exposed Daphnids: Growth rate decreased and the size and colour of the control animals were not reached. The reproduction rate was significant lower than in the parental generation and the F1 generation. The mortality of the parental animals increased. During the test, partially unsaturated IQAC, DMS quaternised, is eliminated in the model activated sludge unit by > 90%. The elimination is calculated to be 97.75% taking into account the inflow into the model activated sludge unit of the test substance with a concentration of 10 mg/l, the dilution of the effluent of the elimination unit in ratio 1:1.25 and the separately determined EC0=0.1 mg/l to Daphnia magna. Thus a NOEC of >100 μg/L is calculated.


 


The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna is more than 10 000 times lower than the toxicity of the test material.Water solubility of the test item may be slightly enhanced leading to a better bioavailability and slightly enhanced toxicity. But these effects are regarded to have a minor influence on the test result.Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.