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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

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 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):

Daphnia magna

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

mortality

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

mortality

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

growth

Remarks:

(length, weight)

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

other: total activity by LSC

Basis for effect:

growth

Remarks:

(length, weight)

Description of key information

21 d EC10 = 0.166 mg/L (Daphnia magna); EPA OTS 797.1330, flow-through, GLP, RL2; read-across from MDEA-Esterquat  C16-18 and C18 unsatd. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC10

Effect concentration:

0.166 mg/L

Additional information

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

 

The 21-day chronic toxicity of MDEA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was investigated under flow-through conditions (using river water) in a study conducted according to EPA OTS 797.1330 (Daphnid Chronic Toxicity Test). Daphnids were exposed to a control and test chemical at measured concentrations of 0, 0.27, 0.47, 1.0, 2.0 and 3.9 mg/L. The 21-day EC50 based on mortality was 1.7 mg/L (95% confidence limits of 1.5 and 1.9 mg/L). The 21 -day NOEC based on survival, number of young/adult/reproduction day, and growth (length and weight) was 1.0 mg/L. Production of offsprings in the treated groups indicated that MDEA-Esterquat C16 -18 and C18 unsatd. had an effect on the reproduction at concentration greater than 1 mg/L.

 

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 21-day chronic toxicity of MDEA-Esterquat C16-18 and C18 unsatd. (Iodine value 47) to Daphnia magna was investigated under flow-through conditions (using river water) in a study conducted according to EPA OTS 797.1330 (Daphnid Chronic Toxicity Test). Daphnids were exposed to a control and test chemical at measured concentrations of 0, 0.1, 0.21, 0.52, 1.08 and 2.10 mg/L. The 21-day EC50 based on mortality was > 2.1 mg/L . The lowest 21-day NOEC based on survival, number of young/adult/reproduction day, and growth (length and weight) was 0.1 mg/L. Production of offsprings in the treated groups indicated that MDEA-Esterquat C16-18 and C18 unsatd. had an effect on the reproduction at concentration greater than 0.52 mg/L. The most sensitive endpoint was adult weight with an EC10 of 0.166 mg/L (95% confidence interval is 0.054 to 0.511 mg/L).

 

The second study is more relevant for the risk assessment of MDIPA Esterquat C18 unsatd. because in this case the source substance have with an IV of 47 an higher structural similarity to the target substance which is composed mainly of unsaturated C18 alkyl chains