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

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:

13 April 2004

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:

Frequency: At the start and the end of both refreshment periods.
Volume: 2 mL from the approximate centre of the test vessels
Storage: Samples were stored in a freezer until analysis.
At the end of each refreshment period, the replicates were pooled at each concentration before sampling.

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):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: Straus, 1820
- Source: In-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24 h
- Method of breeding:
Start of each batch: newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
Maximum age of the cultures: 4 weeks
Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
Temperature of medium: 18-22°C
Feeding: Daily, a suspension of fresh water algae.
Medium: M7, as prescribed by Dr. Elendt-Schneider
- Feeding during test: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

19.2 - 20.8°C

pH:

fresh media: 8.0
24 h old media: 8.1-8.2

Dissolved oxygen:

fresh media: 8.2 - 9.0 mg/L
24 h old media: 8.8 - 9.1 mg/L

Nominal and measured concentrations:

nominal: 0, 0.10, 0.32, 1.0, 3.2, 10 mg/L + 4 mg/L humic acid (2 mg/L DOC), corresponding to measured concentrations of 0.077, 0.27, 0.89, 2.8 and 8.6 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 ml, all-glass, containing 80 ml of test solution
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): renewal of test solutions after 24 h
- 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: Adjusted ISO medium, with 4 mg humic acid per litre
- Total organic carbon: 2 mg/L (measured <1.0 mg/L)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality): at 24 and at 48 h
pH and dissolved oxygen: at the beginning, after 24 hours of exposure and at the end of the test, for all concentrations and the control
Temperature of medium: continuously in a temperature control vessel, beginning at the start of the test

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study
The test concentrations used for final test 1 were based on the results of preceding non-GLP screening tests with Daphnia magna

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 8.6 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

After 48 hours of exposure no (significant) immobility was observed at average exposure concentrations up to and including 0.27 mg/L. A maximum of 10% immobility is not considered to be significant because this percentage of immobilisation is accepted for the control as well. At an average exposure concentration of 0.89 mg/L 40% of the daphnids were immobilised. However, this immobilisation was related to mechanical hampering of the daphnids by undissolved test substance/humic acid and was therefore not considered to be a toxic effect. This conclusion was confirmed by the fact that no (significant) immobilisation was observed at the higher average test concentrations of 2.8 and 8.6 mg/L.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- 48 h EC50=0.53 mg/L, 95% confidence interval 0.49 - 0.62 mg/L; valid range: 0.3 - 1.0 mg/L

At the start of the test measured TOC 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 TOC at 10 mg/L was 4.1 mg/L at the start of the test and decreased to 2.8 mg/L at the end of the refreshment period.

Acute immobilisation of daphnids with humic acid

Nominal conc. HH-2010-324 (mg/l)	Vessel number	Number Daphnia exposed	Response at 24 h		Response at 48 h
			number	Total %	number	Total %
Control	A B C D	5 5 5 5	0 0 0 0	0	0 0 0 0	0
0.10^1	A B C D	5 5 5 5	0 0 0 0	0	1 1 0 0	0
0.32^1	A B C D	5 6 6 5	0 0 0 0	0	0 0 0 0	0
1.0^1	A B C D	5 5 5 5	1^4 0 0 0	5	1^5 3^5 1^5 3^5	40
3.2^2	A B C D	5 5 5 5	0 0 0 0	0	0 0 1 1	10
10^3	A B C D	5 5 5 5	0 0 0 0	0	0 0 0 1	5

¹Clear yellow solution

²(Slightly) hazy yellow solution

³Hazy yellow solution

⁴A test substance precipitate was observed

⁵A test substance precipitate was observed and test substance was observed to be attached to the daphnids

Validity criteria fulfilled:

yes

Conclusions:

The 48 h EC50 of MDIPA Esterquat C18 unsatd. in Daphnia magna was >8.6 mg/L (measured concentration) in the presence of 4 mg/L humic acid.

Executive summary:

The 48–hr-acute toxicity of MDIPA Esterquat C18 unsatd. to Daphnia magna was studied under semi-static conditions.  Daphnids were exposed to control and test chemical at nominal concentrations of 0.10, 0.32, 1.0, 3.2, 10 mg/L, corresponding to measured (TWA) concentrations of 0.077, 0.27, 0.89, 2.8 and 8.6 mg/L in the presence of 4 mg/L humic acid for 48 h.  Mortality/immobilisation and sublethal effects were observed daily. 

The 48-hour EC50 was >8.6 mg/L (TWA) based on immobilisation.  

 

Results Synopsis

Test Organism Age: Daphnia magna, <24 h

Test Type: Static Renewal

 

EC50: >8.6 mg a.i./L

Endpoint(s) Effected:  immobilisation

Description of key information

48 h EC50 > 8.6 mg a.i./L (measured, TWA) (Daphnia magna); OECD guideline 202 (2004), GLP, RL1; in the presence of 4 mg/L humic acid 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

8.6 mg/L

Additional information

The 48–hr-acute toxicity of MDIPA Esterquat C18 unsatd. to Daphnia magna was studied under semi-static conditions.  Daphnids were exposed to control and test chemical at nominal concentrations of 0.10, 0.32, 1.0, 3.2, 10 mg/L, corresponding to measured (TWA) concentrations of 0.077, 0.27, 0.89, 2.8 and 8.6 mg/L in the presence of 4 mg/L humic acid for 48 h.  Mortality/immobilisation and sublethal effects were observed daily. 

The 48-hour EC50 was >8.6 mg/L (TWA, time weighted avarage) based on immobilisation.  

 

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

The 24-hr acute toxicity of MDEA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was investigated under static conditions in a study conducted according to OECD TG 202 (Part I). Daphnids were exposed to 0, 0.1, 0.32, 1.0, 3.2, 10 and 32 mg/L (nominal) for 24 hours. Immobilisation was observed at test termination. The 24-h EC50 was 14.8 mg/L with 95% CL of 8.4 - 26.2 mg/L (nominal each). No other effects were noted. The study period of 24 h was recommended before adoption of the OECD Guideline 202 in 2004. Therefore this study does not meet the time criterium (study duration 24 h instead of 48 h) of today standard methods.

 

The 48 hr-acute toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was studied under semi-static conditions.  Daphnids were exposed to control and test chemical at analytically confirmed nominal concentrations of 0, 2.5, 4.5, 8.1, 14 and 25 mg/L in the presence of 4 mg/L (< 2 mg/L DOC) humic acid for 48 h.  Immobilisation was observed daily. The 48-hour EC50 was 6.7 mg/L (analytically confirmed nominal concentration) based on immobilisation.