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Long-term toxicity to fish

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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 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
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
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) = 0.686 mg/L (measured);

5 d NOEC (based on number hatched) >9.76 mg/L (effective);

(Fathead minnow, Pimephales promelas); US EPA TSCA, 40 CFR, Part 797.1600., flow-through, GLP, RL2; 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:
0.686 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 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%.

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