1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with C18-unsatd. fatty acids, Me sulfates (salts)

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)

Version / remarks:

17 July, 1992

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material: 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C18 unsatd., Me-sulfates (salts)
- Physical state: liquid
- Analytical purity: 100%

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all concentrations, incl. control
- Sampling method: at the start and the end of the first and the last refreshment period, 2 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: samples were stored in the freezer (≤ -15°C); stability of samples under these conditions was demonstrated

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Preparation of test solutions started with a loading rate of 10 mg/L applying 2 hours of magnetic stirring to reach maximum solubility of the test substance in the test medium. The lower test concentrations were prepared by subsequent dilutions of the 10 mg/L concentration in test medium. All test vessels were pre-incubated for 30 minutes with the respective test solution before the start of the test.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: carp
- Strain: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): 2.2 ± 0.1 cm
- Weight at study initiation (mean and range, SD): 0.28 ± 0.08 g
- Feeding during test: no feeding from 24 hours prior to the test and during the total test period

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): same
- Type and amount of food: Daily with pelleted fish food (Cyprico Crumble Excellent (300-500 um), Coppens International bv, Helmond, The Netherlands)
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

180 mg CaCO3/L

Test temperature:

21.2 - 21.9

pH:

7.4 - 8.1

Dissolved oxygen:

in fresh media: 8.8 - 9.3 mg/L
in 24 h old media: 5.4 - 6.7 mg/L

Nominal and measured concentrations:

nominal: 0.10, 0.32, 1.0, 3.2 and 10 mg/L + 4 mg/L humic acid (1.7 and 2.4 mg/L TOC)
measured concentrations were in agreement with nominal (90-93%); concentrations remained stable during both refreshment periods (87-90% of initial); effect parameters can be based on the nominal test concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: 3.5 litres, all-glass, containing 3 litres of test solution
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): daily renewal
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.65 g fish/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis)
CaCl2.2H2O: 211.5 mg/L, MgSO4.7H2O: 88.8 mg/L, NaHCO3: 46.7 mg/L, KCl: 4.2 mg/
- Intervals of water quality measurement: Conductivity, pH, nitrate, nitrite and ammonia concentration: once a week. Temperature: continuous. In addition, pH and temperature were measured before transferring the fish to the test system.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality and other effects: At 3-3½, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1 to observe for any dead or severely distressed fish. Dead fish were removed when observed.
- Dissolved oxygen content, pH and temperature: daily in all vessels with surviving fish, beginning at the start of the test (day 0)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2 (sqrt(10))

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: measured concentration in agreement with nominal

Details on results:

- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: 0/7 fish died
- Other adverse effects control: no
- Abnormal responses: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
- LC50: 0.17 mg/L (95% confidence interval 0.15 - 0.27 mg/L); valid range: 0.10 - 0.46 mg/L based on historical data of reference tests

Sublethal observations / clinical signs:

Measured concentrations were in agreement with nominal (90-93%). These concentrations remained stable during both refreshment periods (87-90% of initial). Given these results, effect parameters can be based on the nominal test concentrations.

 

At the start of the test measured T(D)OC concentrations ranged between 1.7 and 2.4 mg/L for all concentrations up to and including 3.2 mg/L. These concentrations remained stable during the refreshment period. Measured T(D)OC at 10 mg/L was 4.1 mg/L at the start of the test and decreased to 2.1 mg/L at the end of the refreshment period

No mortality or other clinical effect was observed at any of the test concentrations and the control during the 96-hour test period.

Incidence of mortality and total mortality during the final test with humic acid

Nominal conc. HH-2010-324 (mg/l)	Initial number of fish	Cumulative mortality					Total Mortality (%)
		3½h	24h	48h	72h	96h
HA-control	7	0	0	0	0	0	0
0.10^1	7	0	0	0	0	0	0
0.32^1	7	0	0	0	0	0	0
1.0^1	7	0	0	0	0	0	0
3.2^2	7	0	0	0	0	0	0
10^3	7	0	0	0	0	0	0

¹Clear yellow solution

²(Slightly) hazy yellow solution

³Hazy yellow solution (with a floating layer)

 

Validity criteria fulfilled:

yes

Conclusions:

The 96h-LC50 of MDIPA Esterquat C18 unsatd. was > 10 mg/L in carp (Cyprinus carpio) in ISO medium containing 4 mg humic acid per litre (i.e. 2-4 mg dissolved organic carbon per litre).

Executive summary:

In a 96-h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758 were exposed to MDIPA Esterquat C18 unsatd. (100% a.i) at nominal concentrations of 0 (control), 0.10, 0.32,1.0, 3.2 and 10 mg/L under semi-static conditions in the presence of 4 mg humic acid per litre (i.e. 2-4 mg dissolved organic carbon per litre). 

Measured test item concentrations were in agreement with nominal (90-93%). These concentrations remained stable during both refreshment periods (87-90% of initial). Given these results, effect parameters can be based on the nominal test concentrations.

No mortality or other clinical effect was observed at any of the test concentrations and the control during the 96-hour test period. The 96-h LC50 was >10 mg a.i./L. 

 

Results Synopsis

Test organism size/age (mean wet weight or length): Carp (Cyprinus carpio) (2.2 ± 0.1 cm/0.28 ± 0.08 g)

Test Type: Static Renewal

 

LC50:  >10 mg a.i./L

Endpoint(s) Effected: mortality

Description of key information

96 h LC50 > 10 mg a.i/L (nominal) (Carp, Cyprinus carpio), OECD guideline 203, semi-static, GLP, RL1; in the presence of 4 mg humic acid per litre

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

10 mg/L

Additional information

In a 96-h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758 were exposed to MDIPA Esterquat C18 unsatd. (100% a.i) at nominal concentrations of 0 (control), 0.10, 0.32,1.0, 3.2 and 10 mg/L under semi-static conditions in the presence of 4 mg humic acid per litre (i.e. 2-4 mg dissolved organic carbon per litre). 

Measured test item concentrations were in agreement with nominal (90-93%). These concentrations remained stable during both refreshment periods (87-90% of initial). Given these results, effect parameters can be based on the nominal test concentrations.

No mortality or other clinical effect was observed at any of the test concentrations and the control during the 96-hour test period. The 96-h LC50 was >10 mg a.i./L. 

 

Similar results were obtained with the closely related read-across substances MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd.:

In a 96 h acute toxicity study according to OECD TG 203, the Zebrafish (Danio rerio), was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0, 1.0, 1.6, 2.5, 4.0, 6.3 and 10 mg/L under static conditions. The nominal 96 h LC50 value based on mortality was 5.2 mg/L (95% C.I.: 4.4 to 6.3 mg/L). Mortality occurred in the first 48 h. After this time, seemingly moribund organisms recovered. Within the first 48 h the test solutions at concentrations of 2.5, 4.0, 6.3, and 10 mg/L showed a Tyndall effect. The intensity increased with increasing concentrations. Precipitates were observed on the bottom of the test aquarium in the exposure concentrations of 2.5 to 10 mg/L 48 h after preparation of the test solution. These observations suggest that mortality is most likely a physical and not a toxic effect due to the undissolved particles in the water phase. 5 additional fish were added to the 10.0 mg/L solution after 48 h (the time the precipitates were observed). The animals survived until test termination which supports the assumption of physical effects.

 

The 96–hr-acute toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to eggs of Danio rerio was studied under semi-static conditions according to guideline OECD guideline 236 (2013). Eggs were exposed to control and test chemical at analytically determined geometric mean concentrations of 0, 0.986, 1.90, 4.15, 8.05, and 16.0 mg/L under semi-static conditions with daily renewal. The 96-hour LC50 was estimated to be 11.7 mg/L with 95% confidence limits of 9.91 and 13.8 mg/L.