Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 9.84 - <= 10.24 mg/L

95% CI:

>= 2.7 - <= 11.73

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Description of key information

The 96-h LC50 was 9.84 — 10.24 mg/L (nominal, confidence interval: 2.7 - 11.73 mg a.i./L); read-across from Partially unsaturated IQAC, DMS quaternised.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

9.84 mg/L

Additional information

Experimental data on short-term toxicity of C1618FA-TEPA-compoundare not available. A study was conducted with the structurally related source substance Partially unsaturated IQAC, DMS quaternised. A justification for read-across is attached to Iuclid section 13.

In a 96-h acute toxicity study, Rainbow trouts (Salmo-Gardia, Shasta, Oncorhynchus mykiss) were exposed to partially unsaturated IQAC, DMS quaternised at nominal concentrations of 10.0, 13.3, 17.6, 23.3, 30.8 mg test mat. /L.  The 96-h LC50 was 9.84 – 10.24 mg act. ingr./L (nominal, Confidence interval: 2.7 - 11.73 mg a.i./L) .  Sublethal effects were not observed. The observed concentration/response curve is very steep. The test material contains considerable amounts of isopropanol. The toxicity of isopropanol against fish is about 100 to 1000 times lower than the toxicity of the test material. 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.