Alcohols, C8-10, ethoxylated, sulfates, ammonium salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Feb - 10 Mar 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

adopted 13 April 2004

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 110 mg a.i./L sampled at 0 hours and at 48 hours
- Sampling method: At the start of the test (0 hour), 5 mL new media samples were taken from the freshly prepared control and test media flasks. At the end of the test period (48 hours), 5 mL old media samples were taken from pooled control and test vessels. The samples were taken using an air displacement pipette fitted with a plastic pipette tip into 20 mL glass scintillation vials containing 5 mL of methanol.
- Sample storage conditions before analysis: no, samples were analysed on the day of receipt

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 110 mg a.i./L test solution (equivalent to 328 mg test substance/L) was prepared by adding 164.16 mg of test substance to 500 mL of autoclaved Elendt M4 medium.
- Other relevant information: The test media and the control were checked for the tyndall effect using a Hach 2100 N turbidity meter. The turbidity measurement for the test solution was not significantly different to the measurement for the control and therefore the test solution was considered a true solution.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: cultured in 1 litre glass beakers containing 1000 mL of Elendt M4 medium. Fed daily with a concentrated suspension of Chlorella vulgaris
- Source: in-house culture setup originally from dormant eggs (ephippia) supplied by MicroBioTests Inc., Belgium
- Feeding during test : no

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

19.9 – 20.0°C

pH:

7.74 – 8.78

Dissolved oxygen:

8.05 - 8.79 mg/L

Nominal and measured concentrations:

Nominal test substance concentration: 110 mg a.i./L
Analysis of the 110 mg a.i.L test concentration at 0 hours showed recoveries of between 110 – 116% of nominal for all the targeted constituents.

Details on test conditions:

TEST SYSTEM
- Test vessel: tall form beakers
- Type (delete if not applicable): covered with clear plastic petri dish lids
- Material, size: glass, 100 mL
- Volume of solution: 50 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: sterilised Elendt M4 me
- Culture medium different from test medium: no
- Intervals of water quality measurement: at 0 and 48 h (contionous measurment of temperature)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light: 8 hour dark cycle (fluorescent lighting)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility after 24 and 48 hours

RANGE-FINDING STUDY
- Test concentrations: 0.1, 1, 10 and 100 mg a.i./L
- Results used to determine the conditions for the definitive study: 0% immobilisation observed

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 110 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: Concentration based on eight representative constituents

Details on results:

- Other adverse effects control: 1 daphnid appeared lethargic at 24 hours
- Immobilisation of control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no precipitation observed

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Dose-response test: yes
- EC50: (48 h): 1.48 mg/L (95% CL: 0.746 - 2.92 mg/L)

Reported statistics and error estimates:

No statistical analysis was performed (limit test)

Table 1. Toxicity to D. magna

Nominal Concentration [mg Active Ingredient/L]	Number of Daphnia magna exposed	Immobility at 24-hours [%]	Immobility at 48-hours [%]
Control	20	0	0
110	20	0	0

Table 2: Validity criteria for OECD 202 (2004)

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	≥ 8.05 mg/L	yes

 

Table 3: Percentage Recovery of constituent from Nominal at 110 mg AI/L

(Concentrations of constituent established based on the content corrected concentrations) (%)

Constituent analysed	0-hour New Media	48-hour Old Media
Ammonium octyl sulfate	115	103
1-Octanol, ethoxylated (1 EO), sulfated, ammonium salt	113	104
1-Octanol, ethoxylated (2 EO), sulfated, ammonium salt	113	100
1-Octanol, ethoxylated (3 EO), sulfated, ammonium salt	116	101
Ammonium decyl sulfate	115	104
1-Decanol, ethoxylated (1 EO), sulfated, ammonium salt	114	99
1-Decanol, ethoxylated (2 EO), sulfated, ammonium salt	110	100
1-Decanol, ethoxylated (3 EO), sulfated, ammonium salt	112	106

AI = Active ingredient

Validity criteria fulfilled:

yes

Remarks:

Please refer to table 2 at "Any other infrmation on results incl. tables"

Description of key information

EC50 (48 h) > 110 mg a.i./L, nominal (D. magna, OECD 202)

Additional information

The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to aquatic toxicity will be updated once all ongoing studies have been finalised.

One key study investigating the acute toxicity of Alcohols, C8-10, ethoxylated, sulfates, ammonium salts to aquatic invertebrates is available. The GLP guideline study was conducted under static conditions according to OECD 202. The test was performed with limit concentration of 110 mg a.i./L. The test concentration was analytically monitored by LC-MS/MS. Recovery rates were ≥ 99% of nominal. No immobilisation was observed. The determined EC50 (48 h) > 110 mg a.i./L (nominal).