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

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 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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Analytical monitoring:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: NIES
D. magna less than 24 hr old were used at the start of the test.

ACCLIMATION
- Type and amount of food: 0.3 ml of S. capricornutum (4e04 cells/ml) and 0.3 ml of YCT (a mixture of yeast, Cerophyll, and trout chow used as food) were added to each 400-ml culture beaker every day.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

110 mg/l CaCO3

Test temperature:

24 ± 1°C

pH:

7.0 to 7.5

Dissolved oxygen:

80% to 99% saturation

Details on test conditions:

Daphnids were cultured and kept at 25 ± 1°C under a 16-hr light/8-hr dark photoperiod. 0.3 ml of S. capricornutum (4 × 104 cells/ml) and 0.3 ml of YCT (a mixture of yeast, Cerophyll, and trout chow used as food) were added to each 400-ml culture beaker every day.

TEST SYSTEM
- Test vessel: glass chambers (50 ml), tightly closed with Teflon caps to prevent volatilization, 40 ml test solution
- Renewal rate of test solution: every 1 or 2 days
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10

Survival and reproduction tests on D. magna were continued for 21 days in accordance with the methods proposed by the OECD.
D. magna less than 24 hr old were used at the start of the test. They were exposed to various concentrations of the test substance according to the OECD test conditions, then observed and fed daily during 21 days.
Neonatal fleas were counted every day. The total number of fleas born over the 21 days in the test fluids of each concentration and the total number born in the control group were statistically processed to determine the IC25, the LOEC, and the NOEC.

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

125 µg/L

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

other: IC25

Effect conc.:

211.2 µg/L

Conc. based on:

test mat.

Basis for effect:

reproduction

Conclusions:

In this Daphnia reproduction test the NOEC for DDAC in Daphnia magna was determined to be 125 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.

Description of key information

NOEC = 312.5 µg/L (based on read-across)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

312.5 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 in fish are available for the closely related source substance DDAC. A justification for read-across is attached to IUCLID section 13.

In a 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.