1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

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 share structural similarities with common functional groups: quaternary amines, esters, and fatty acid chains varying in their length and degree of (un)saturation. Moreover, the fatty acid chains are chemically simple structures which have no structural alerts for toxicity, and which are closely related to substances of known low toxicity (i.e. stearic acid, oleic acid, linoleic acid, linolenic acid). Furthermore, the substances can be expected to have comparable breakdown products (MDEA or MDIPA and 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 MDIPA-Esterquat C16-18 and C18 unsatd. are predicted to be similar to those of the source substances MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA Esterquat C18 unsatd.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See justification for read-across attached to chapter 13 of this IUCLID file.

3. ANALOGUE APPROACH JUSTIFICATION
See justification for read-across attached to chapter 13 of this IUCLID file.

4. DATA MATRIX
See justification for read-across attached to chapter 13 of this IUCLID file.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

Duration:

14 d

Dose descriptor:

LC0

Effect conc.:

> 47.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 47.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC100

Effect conc.:

> 47.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Description of key information

Eisenia fetida

14 d LC50>47.4 mg a.i./kg dry soil

14 d EC50>47.4 mg a.i./kg dry soil

14d-NOEC and LOEC, based on appearance and behavior: > 47.4 mg act. ingr./kg dry soil (nominal each)

OECD guideline 207, RL1, GLP; read-across from MDEA-Esterquat C16-18 and C18 unsatd.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

47.4 mg/kg soil dw

Additional information

No experimental data are available for the target substance MDIPA Esterquat C16-18 and C18 unsatd.  However, an acute toxicity study in earthworms is available for the source substance MDEA-Esterquat. A justification for read-across isattached to Iuclid section 13.

In a 14-day acute toxicity study, earthworms (Eisenia fetida) were exposed to MDEA-Esterquat C16-18 and C18 unsatd.  at 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil (artifical soil). The experiment was carried out according to OECD TG 207. The 14 day LC50 value was determined to be >47.4 mg a.i./kg soil dry weight (nominal). The 14 d EC50 was >47.4 mg a.i./kg dry soil. The 14 d NOEC and LOEC, based on appearance and behaviour was >47.4 mg a.i./kg dry soil. No compound related toxicity effects were noted.

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with earthworms.