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

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

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 C18 unsatd. are predicted to be similar to those of the source substances MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA Esterquat C16-18 and 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

Reason / purpose for cross-reference:

read-across source

Test organisms (species):

Pimephales promelas

Duration:

5 d

Dose descriptor:

NOEC

Effect conc.:

> 9.76 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

other: pre-fry reduction mortality, number hatched

Key result

Duration:

35 d

Dose descriptor:

NOEC

Effect conc.:

0.686 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

other: length, weight, post-fry reduction mortality

Duration:

35 d

Dose descriptor:

LOEC

Effect conc.:

1.41 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

other: post-fry reduction mortality

Duration:

35 d

Dose descriptor:

LC50

Effect conc.:

1.67 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

other: post-fry reduction mortality

Remarks on result:

other: 95% CL 1.45 and 1.91 mg/L

Description of key information

35 d NOEC (based on mortality and sub-lethal effects) = 0.313 mg/L (measured); 
(Fathead minnow, Pimephales promela); OECD Guideline 210, flow-through, GLP, RL1; read-across from MDEA-Esterquat C16 -18 and C18 unsatd. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

0.313 mg/L

Additional information

No experimental data are available for the target substance MDIPA Esterquat C18 unsatd. However, a long term toxicity studies in fish are available for the source substance MDEA-Esterquat C16 -18 and C18 unsatd.; a justification for read-across is attached to Iuclid section 13.

 

The 35-day chronic toxicity of MDEA-Esterquat C16 -18 and C18 unsatd. to early life stages of Fathead minnow, Pimephales promelas, was studied under flow-through conditions using river water, according to US EPA TSCA, 40 CFR, Part 797.1600. Fertililized eggs (25 eggs, reduced to 15 fry after hatch) were exposed to a control and measured concentrations of 0.686, 1.41, 2.68, 5.30 and 9.76 mg/L as total activity by LSC. The test system was maintained at 25 +/- 1°C and a pH of 8.0 (7.7 to 8.3). The 35-day NOEC values, based on mortality (post-fry reduction) and sub-lethal effects (length and weight) were 0.686 mg/L. The 5-day NOEC based on number hatched was >9.76 mg/L. Although the post-fry reduction survival did not monotonically decrease with exposure concentration, a NOEC of 0.686 mg/L could statistically be determined. Although survival in one control chamber prior to fry reduction and one control chamber at test termination was <70%, the NOEC of 0.686 mg/L met validity criteria of survival in each chamber of >70%.

 

Additional results from a MDEA-Esterquat C16-18 and C18 unsatd. with a fatty acid distribution shifted to a higher amount of unsaturated C18 are available:

 

The 35-day chronic toxicity of MDEA-Esterquat C16-18 and C18 unsatd. (Canola oil based) to early life stages of Fathead minnow, Pimephales promelas, was studied under flow-through conditions using river water, according to OECD guideline 210. Fertililized eggs (25 eggs, reduced to 20 fry after hatch) were exposed to a control and measured concentrations of 0.313, 0.682, 1.34, 2.47 and 4.94 mg diester/L. The test system was maintained at 25 +/- 1°C and a pH of 8.3 (8.2 to 8.4). The 35-day NOEC values, based on mortality (post-fry reduction) and sub-lethal effects (length and weight) were 1.34 mg/L and 0.313 mg/L, respectively. The 35-day NOEC based on number hatched was 2.47 mg/L.

 

The second study is more relevant for the risk assessment of MDIPA Esterquat C18 unsatd. because in this case both the target and the source substance are manufactured from the same fatty acid source (Canola oil) and have therefore an almost identical fatty acid distribution and in addition the study is with an Klimisch rating of 1 instead of 2 more reliable.