Sulfuric acid, mono-C8-18-alkyl esters, magnesium salts, compds. with triethanolamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch no.: 0016420429
- Purity: ca. 76 %
- Impurities: 17.9 % triethanolamine, 2.5 % sulfates, 2.5% Mg, 1.6% water, 0.05 % cyclohexanol


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
The stability of the test substance under storage conditions over
the test period was guaranteed by the sponsor, and the sponsor
holds this responsibility.

Analytical monitoring:

yes

Details on sampling:

The concentration control analysis was performed with the three highest test groups, the lower test concentrations were below the Limit of Quantification (LOQ).

Sampling for concentration control analysis was performed for 2 renewal intervals. For the first interval samples were collected within 30 min before insertion of the test organisms (0 h) from the test vessels and after 24 hours from test vessels with surviving fish and the lowest concentration with 100% mortality. For the second renewal interval, samples were collected from fresh test solutions within 30 min of test solution renewal at 48 h and after 72 hours from the test vessels with surviving fish.

Vehicle:

no

Details on test solutions:

The test treatments were prepared separately for each test vessel. The defined volume of test water was filled into the test vessel. An aliquot from the test water in the test vessel was taken and mixed with the test substance using a high shear mixer and the mixture was poured into the test vessel and the whole test batch was homogenized again with an ultra turrax. The test treatments were then stirred for approx. 1 hour with a magnet stirrer to ensure that the test substance is completely dissolved.
Fresh test solutions were prepared daily.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
Test species: Zebrafish (Danio rerio)
Animal supplier: Ruprecht Karls Universität Heidelberg Centre for Organismal Studies Heidelberg, Heidelberg, Germany
Delivered as fertilized eggs and the fish were hatched at the testing facility.
Body length(a): 1.9 cm (range 1.8 cm – 2.0 cm)
Body weight(a): 0.06 g (range 0.03 g – 0.09 g)
Age of the animals: Approx. 4 months
Hatching date: 09–11 Mar 2019
Arrival at the testing facility: 07 Mar 2019 as fertilized eggs

ACCLIMATION
- Acclimation period: 9 days.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: Commercial fish diet ”TetraMin“ ad libitum and live juvenile brine shrimp
- Feeding frequency during acclimation: daily. no feeding approx. 24h before starte of exposure
- Health during acclimation (any mortality observed): no mortality

FEEDING DURING TEST (as applicable)
None

Test type:

semi-static

Water media type:

freshwater

Remarks:

non chlorinated charcoal-filtered drinking water from the municipal water works of the city of Frankenthal mixed with deionized water, hardness approx. 100 mg/L as CaCO3, pH generally 7.5 - 8.5

Limit test:

no

Total exposure duration:

96 h

Hardness:

Ca. 1 mmol/L = 100 mg/L CaCO3

Test temperature:

22 °C

pH:

7.5 - 8.5

Dissolved oxygen:

>60% ASV (air saturation value)

Conductivity:

Ca. 250 µS/cm

Nominal and measured concentrations:

Nominal: 0, 0.22, 0.46, 1.0, 2.2, 4.6, 10 mg/L
Mean Measured: 0, 0.19, 0.39, 0.85, 1.9, 3.7, 8.5 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L stainless steel aquaria (29 x 21 x 22 cm)
- Aeration: none
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.042 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: nonchlorinated
charcoal filtered drinking water (Frankenthal, Germany) mixed with deionized water and aerated to achieve the following water characteristics. The mixed test water is sanitized by UV treatment prior to entering the aquaria.
- Total organic carbon: < 2 mg/L
- Ca/mg ratio: about 8

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light, 8h dark
- Light intensity: ca. 98 - 287 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and toxic signs
- Observations intervals: 1, 6, 24, 29, 48, 53, 72, 79, 96 h

TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: preliminiary test with zebrafish LC50 (48h) between 1 and 10 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.91 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality in control: 0%

Sublethal observations / clinical signs:

- 4.6 mg/L: 2 fishes swimming at the bottom (24 h), 1 fish swimming at the bottom (29 h)

 

Validity criteria fulfilled:

yes

Conclusions:

The test substance is acutely toxic to fish.

Description of key information

LC50 (96h) = 2.91 mg/L (mean measured) for mortality of Danio rerio (OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

2.91 mg/L

Additional information

One study investigating the short-term toxicity of the test substance to aquatic invertebrates is available. The study was conducted according to OECD guideline 203 and GLP using Danio rerio as test organism (BASF SE, 2020). Nominal concentrations between 0.22 and 10 mg/L were tested. The expsoure was analytically verified. No mortality was observed in the control. After an exposure time of 96 h the EC50 is determined to be 2.91 mg/L basd on mean measured concentrations. Thus, the test substance can be considered as acutely toxic to fish.