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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-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

Reason / purpose for cross-reference:

read-across source

Test organisms (species):

Daphnia magna

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

48 h

Test temperature:

21°C

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.7 mg/L

95% CI:

>= 2.6 - <= 4.9

Nominal / measured:

estimated

Conc. based on:

other: water accommodated fractions (WAFs)

Basis for effect:

mobility

Description of key information

The nominal 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna under semi-static conditions was EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits (OECD 202). The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

3.7 mg/L

Additional information

Experimental data on short-term toxicity to aquatic invertebrates of C1618FA-TEPA-compound are not available. However,  short-term, toxicity studies in Daphnia magna were conducted with the structurally related source substance Partially unsaturated IQAC, DMS quaternised. A justification for read-across is attached to Iuclid section 13.

The 48–hr-acute toxicity of the closely related Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied according to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

In another study, the 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions.  Daphnids were exposed for 24 hr according to DIN 38 412 Part 11.  Mortality/immobilization was observed.  The 24 – hour EC50was 0.45 – 0.9 mg a.i../L.  The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L. The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 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.

According to REACH Endpoint specific Guidance R.7b, pp 24, 24 hour values can have considerable variability in the repeatability of results. Therefore standard 48 hour values are favoured over 24 hour values. 24 hour values should only be used in the absence of good quality 48 hour values with other available supporting data.