N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate

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 properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: quaternary ammonium and saturated or unsaturated alkyl chains

The read-across hypothesis is based on structural similarity of target and source substances. The target and source chemicals have a similar structure in that they are comprised of a hydrophobic (alkyl) and hydrophobic (positively charged ammonium) end. Due to this motif they form micelles (colloidal dispersions) and have surfactant properties.

This read-across hypothesis corresponds to scenario 2 of the Read-Across Assessment Framework (RAAF), ECHA, March 2017 - different compounds have qualitatively similar properties - of the read-across assessment framework i.e. properties of the target substance are predicted to be quantitatively equal to those of the source substance. Namely, the structurally similar source substances DDAC and DODMAC predict the ecotoxicological properties of the target substance Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates.

Based on available experimental data, including key physicochemical properties and data from short-term aquatic ecotoxicity studies, the read-across strategy is supported by a similar ecotoxicological profile of the substances.

Ecotoxicological, physicochemical and environmental fate data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.

Therefore, read-across from the existing ecotoxicity and environmental fate studies conducted with the source substances 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 justification for read-across attached to iuclid section 13.

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to justification for read-across attached to iuclid section 13.

4. DATA MATRIX
Please refer to justification for read-across attached to iuclid section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Principles of method if other than guideline:

This test was performed to investigate the effects (hatch/growth/survival) of test substances on fish (Medaka and Zebrafish) continuously exposed from hatching to the larval or fry stages, which are thought to be the most sensitive to toxicity.
Piron, R. D. (1978) Spontaneous skeletal deformities in the Zebra Danio (Brachydanio rerio) bred for fish toxicity tests. J. Fish Biol., 13, 79–83.
Neilson, A. H., Allard, A. S., Fischer, S., Malmberg, M. and Viktor, T. (1990) Incorporation of a subacute test with zebra fish into a hierarchical system for evaluating the effect of toxicants in the aquatic environment. Ecotoxicol. Environ. Saf., 20, 82–97.

GLP compliance:

not specified

Test organisms (species):

other: Medaka and Zebrafish

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Remarks on exposure duration:

9 days (Zebrafish) and 14 days (Medaka)

Hardness:

200 mg/l as CaCO3

Test temperature:

25 ± 1°C

pH:

pH 7.0 ± 0.5

Nominal and measured concentrations:

2.5, 1.25, 0.625, 0.313, 0.156, and 0 mg/L

Reference substance (positive control):

no

Duration:

9 d

Dose descriptor:

NOEC

Remarks:

Zebra fish

Effect conc.:

312.5 µg/L

Conc. based on:

test mat.

Basis for effect:

other: hatch/ growth/survival

Duration:

9 d

Dose descriptor:

other: IC25

Remarks:

Zebra fish

Effect conc.:

439.7 µg/L

Conc. based on:

test mat.

Basis for effect:

other: hatch/ growth/survival

Duration:

14 d

Dose descriptor:

NOEC

Remarks:

Medaka

Effect conc.:

1 250 µg/L

Conc. based on:

test mat.

Basis for effect:

other: hatch/ growth/survival

Duration:

14 d

Dose descriptor:

other: IC25

Remarks:

Medaka

Effect conc.:

1 563 µg/L

Conc. based on:

test mat.

Basis for effect:

other: hatch/ growth/survival

Conclusions:

In this fish early life stage test the NOEC for DDAC in Zebra fish was determined to be 312.5 µg/L, the NOEC in Medaka was 1250 µg/L. Based on the read-across hypothesis, these results are also applicable to the target substance Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

125 µg/L

Additional information

No experimental data are available for the target substance Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates. However, long-term toxicity studies to Dapnnia magna are available for the closely related source substance DDAC. A justification for read-across is attached to IUCLID section 13.

In a Daphnia reproduction test the NOEC for DDAC in Daphnia magna was determined to be 125 µg/L.