Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

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:

other: GLP guideline study with analytical monitoring

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test substance was homogenized by shaking the container before use then weighted into a beaker. The defined volume of test water was filled into the stock solution tank. An aliquot from the test water in the stock solution tank was taken and mixed with the test substance using an ultra turrax high shear mixer and the mixture was poured into the test vessel and the entire stock solution was stirred continuously with a winged stirrer. Fresh stock solution was prepared daily.

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
- Common name: Bluegill Sunfish
- Source: Osage Catfisheries Inc., Osage Beach, MO 65065, USA
- Age at study initiation: Approx. 8 months
- Length at study initiation (from the top of the snout to the end of the caudal fin): 3.3 cm (3.1 – 3.6 cm)
- Weight at study initiation (wet wight): 0.34 g (0.22 – 0.41 g)
- Feeding during test: none

ACCLIMATION
- Acclimation period: >=14 days to test water, photoperiod and temperature
- Acclimation conditions: same as test
- Photoperiod: 16 hours light, 8 hours darkness
- Water quality: Non chlorinated charcoal filtered tap water mixed with deionized water
- Total hardness: Approx. 1 mmol/L = 100 mg/L CaCO3
- Acid capacity: Approx. 2.5 mmol/L
- Oxygen content: > 80% saturation
- pH-value: Generally 7.5 – 8.5
- Temperature: Approx. 23 °C
- Type and amount of food: Ecostart 17 (Bio Mar), supplier Kofu Tiernahrung, Betriebsstätte Wesel, 46483 Wesel, Germany
- Feeding frequency: ad libitum, additionally generally on workdays frozen brine shrimp (artemia).
- Medical treatment: None during acclimatization
- Mortality during the last week before start of exposure: < 5%

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

23 - 24 °C

pH:

7.6 - 8.0

Dissolved oxygen:

6.2 - 8.4 mg/L

Nominal and measured concentrations:

Nominal test concentrations: control, 5.6, 10, 18, 32, 56 mg/L
Mean measured test concentrations: not detected, 4.8, 6.8, 15.2, 28.8, 47.4 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, fill volume: Glass aquaria with stainless steel frame (43.5 cm long, 11 cm wide, 25 cm high), 9 L
- Aeration: Slight aeration during the exposure, since the oxygen content was approx. 73% ASV in the highest test concentration at the start of exposure
- Type of flow-through: proportional diluter
- Renewal rate of test solution (frequency/flow rate): Approx. 3.75 L/h (62.5 mL/min) resulting in 5 volume changes per day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.38 g

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: non chlorinated charcoal filtered tap water mixed with deionized water, aerated
- Alkalinity: approx. 2.5 mmol/L
- Ca content: approx. 40 mg/L
- Mg content: approx. 5 mg/L
- Conductivity: approx. 250 μS/cm (at 25°C)
- Intervals of water quality measurement: Temperature, flow, oxygen content and pH-value were measured in each test vessel within 1 h after start of exposure and after 24, 48, 72 and 96 hours.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours darkness
- Light intensity: Approx. 70 - 570 Lux (the light intensity is determined in regular intervals at the surface of the aquaria)

EFFECT PARAMETERS MEASURED: mortality and toxic signs within 1 hour after start of exposure and 6, 24, 48, 72, 96 hours after start of exposure

TEST CONCENTRATIONS
- Range finding study: yes
- Results used to determine the conditions for the definitive study: LC50 ranges between 1 and 10 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

15.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

6.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

28.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

6.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Details on results:

- Behavioural abnormalities:
- at 18 mg/L (nominal):
- tottering (3 fish after 48 h)
- apathy (2 fish after 72 h, 2 fish after 96 h)
- at 32 mg/L (nominal):
- swimming at the surface (5 fish after 1 h)
- apathy (2 fish after 6 h)
- at 56 mg/L (nominal):
- swimming at the surface (5 fish after 1 h)
- tottering (1 fish after 1 h)

- Mortality of control: none after 96 h

- Effect concentraions after 72 hours:
LC0 = 6.8 mg/L
LC50 = 15.7 mg/L
LC100 = 28.8 mg/L

- Effect concentraions after 48 hours:
LC0 = 6.8 mg/L
LC50 = 18.1 mg/L
LC100 = 28.8 mg/L

- Effect concentraions after 24 hours:
LC0 = 15.2 mg/L
LC50 = 20.9 mg/L
LC100 = 28.8 mg/L

Validity criteria fulfilled:

yes

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Principles of method if other than guideline:

Acute toxicity test performed according to the "Chemicals rare minnow acute toxicity test" published by the China National Technical Committee for Standardization of Dangerous Chemicals Management: GB/T 29763-2013, China Standards Press

GLP compliance:

yes

Analytical monitoring:

no

Details on sampling:

- Concentrations: control and treatment
- Sampling method: Samples were taken at Oh, 96h and 24h, 48h, 72h (before and after the renewal test solution) after the start of the test.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 0.5 g test substance was weighed into a 5L-jar and 5000mL test water was added to obtain the nominal concentration of 100 mg/L test suspension. Then it was stirred with a magnetic stirrer for about 24h (the depth of vortex maintained at the range of 3-4cm). The suspension was filtered over a 0.22 μm filter membrane and the filter solution was collected as 100% saturated test substance solution (loading rate WAF).

Test organisms (species):

other: Gybiocypris rarus

Details on test organisms:

TEST ORGANISM
- Common name: rare minnow
- Source: Southwest University
- Feeding during test: no

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: not specified
- Feeding frequency: three times per week until 24h prior to test start
- Health during acclimation (any mortality observed): The mortality was 0%.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.2 - 24.6 °C

pH:

7.34 - 8.09

Dissolved oxygen:

>= 60% of the air saturation value

Nominal and measured concentrations:

Nominal: 100 mg/L loading rate WAF

Details on test conditions:

TEST SYSTEM
- Test vessel: 5L test vessel containing 4 L test solution
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): every 24h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.513 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: The temperature, pH and dissolved oxygen of each test group were measured at Oh, 96h, and 24h, 48h, 72h (before and after the renewal of the test solution) after the start of the test.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14h light/ 10h dark
- Light intensity: artificial light of white fluorescent lamp, 613 - 620 lux

EFFECT PARAMETERS MEASURED: Mortal ity and visible abnonnali ty of the test fish were recorded at 24h, 48h, 72h and 96h after the start of the test during test period. The body weight and length of 10 test fish in the blank control were measured at the end of the test.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Details on results:

No mortality was observed in the control and the 100 mg/L loading rate WAF throughout the exposure time.
There were no abnonnal responses of test fish observed in the blank control and test group.
During the test period, the observation appearance of blank control and test substance group were all clear and colorless.

Results with reference substance (positive control):

24h-LC50 of the reference substance (K2Cr20 7) was 432 mg/L to Rare Minnow (Gybiocypris rarus) and the 95% confidence limits was 349 mg/L to 511 mg/L.

Sublethal observations / clinical signs:

DOC analysis

The geometric mean of DOC concentration of blank control at 0h (new solution), 96h ( old solution), 24h (new and old solution), 48h (new and old solution) and 72h (new and old solution) was 3.27mg/L. The geometric mean of 100% LS was 39.2 mg/L. The measured concentration of DOC of the test group attributable to the test substance was 35.9 mg/L after subtraction of the background of the blank control.

Validity criteria fulfilled:

yes

Conclusions:

The test substance is not harmful to rare minnow.

Description of key information

LC50 (96h) = 15.2 mg/L (measured) for Lepomis macrochirus (OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

15.2 mg/L

Additional information

Two studies investigating the short-term toxicity of Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide (CAS 1000817-22-0) to fish are available. The key was performed according to GLP and OECD guideline 203 using bluegill (Lepomis macrochirus) as test organism (BASF 2008). After 96 hours of exposure under flow-through conditions the LC50 is determined to be 15.2 mg/L based on measured concentrations. A supporting study was performed under GLP and according to the "Chemicals rare minnow acute toxicity test" published by the China National Technical Committee for Standardization of Dangerous Chemicals Management: GB/T 29763-2013, China Standards Press. Gobiocypris rarus was used as test organism. A 100 mg/L loading rate WAF (using a 0.22 µm filter) was tested in a limit test. No mortality was observed in control and treatment throughout the test duration. Thus, the 96h-LL50 value is determined to be > 100 mg/L loading rate WAF. Based on the lowest available LC50 value of 15.2 mg/L, the test substance is considered to be toxic to fish.