Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

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:

26/02/2001- 07/07/2001

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No information provided.

Analytical monitoring:

yes

Details on sampling:

Samples to determine the concentration and stability of the test material in the test solutions were taken at the beginning of the study (fresh media), after 24 hours (old and fresh media), and after 48 hours (old media). Duplicate 500ml samples were collected in pre-conditioned glassware and extracted with dichloromethane (3 x 30 ml) after addition of sodium chloride (150 g). Extracts were filtered through anhydrous sodium sulphate. The extracts were then evaporated to dryness and the residue re-dissolved in acetonitrile to give a final theoretical concentration of 5 mg/l to 32 mg/l.

- Concentrations: 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg a.s./l
- Sampling method: Dissolved oxygen, water temperature and pH were measured daily during the test.

Vehicle:

yes

Details on test solutions:

A 100 mg/l solution was created by dissolving 100 mg of the test substance in 1 litre of reconstituted water with the aid of ultrasonification. Aliquots of this stock solution were further diluted to create a 1.0 mg/l test concentration. Aliquots of the 1.0 mg/l test solution were each seperately dispersed in reconstituted water and the volume adjusted to 5 litres to give nominal test concentrations of 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg a.s./l. Test media was renewed after 24 hours.

Test organisms (species):

Daphnia magna

Details on test organisms:

All organisms used in the study were 1st instar Daphnia magna derived from in-house laboratory cultures. Adult daphnia were maintained in polypropylene vessels containing approximately 2 litres of reconstituted water at 21oC. Cultures were fed daily with suspensions of algae (Chlorellasp.) Gravid adults were isolated the day before initiation of the test to ensure that test daphnids were less than 24 hours old. The diet and diluent water were considered not to contain any contaminant that would affect the outcome of the study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

The daphnia magna were exposed to the test substance for 48 hours from the start of exposure.

Hardness:

Approximately 250 mg/l CaCO3

Test temperature:

21°C

pH:

7.9-8.0

Dissolved oxygen:

8.2-8.4 mg O2/l

Salinity:

No information provided.

Nominal and measured concentrations:

Initial test concentrations: 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg a.s./l
The test concentrations were all shown to be within 80% to 120% of the nominal values for the actual concentrations of the test susbtance, with one exception.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass jars.
- Fill volume: 250ml
- Type of system: Semi-static
- No. of organisms per vessel: 10 daphnids were placed in duplicate in each of the test and control vessels.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness.

EFFECT PARAMETERS MEASURED: Immobility was the effect parameter measured.

TEST CONCENTRATIONS
- Test concentrations: Initial test concentrations: 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg a.s./l
The test concentrations were all shown to be within 80% to 120% of the nominal values for the actual concentrations of the test susbtance, with one exception.

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.039 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

0.039 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.07 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

0.22 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

The results of this study indicate that Bardap 26 is toxic to Daphnia magna. The no-observed-effect concentration (NOEC) calculated from the results of this study was 0.039 mg a.s./l. The 48hr EC50 was found to be 0.07 mg a.s./l. The 48hr EC100 was 0.22 mg a.s./l. No behavioural abnormalitites were observed in any of the test or control groups.

Results with reference substance (positive control):

No information provided.

Reported statistics and error estimates:

ToxCalc software used to calculate EC50 and their 95% confidence limits. No information is provided on reported statistics and error estimates.

100% immobilisation was observed in the 0.7 mg a.s./l and 0.392 mg a.s./l test group after 24 and 48 hour respectively and in the 0.224 mg a.s/l test group after 48 hours.

 

Cumulative immobilisation

 

Nominal concentration (mg a.s./l)	Cumulative Immobilised Daphnia
	24 hours		48 hours
	Total	%	Total	%
0	0	0	0	0
0.007	0	0	0	0
0.0126	0	0	0	0
0.0224	0	0	0	0
0.0392	0	0	0	0
0.07	0	0	14	70
0.126	0	0	16	80
0.224	8	40	20	100
0.392	20	100	20	100
0.7	20	100	20	100

Validity criteria fulfilled:

yes

Conclusions:

Based on concentration effect relationship observed, the no-observed-effect concentration (NOEC) was found to be 0.039 mg/l under the conditions of the study. The EC 50 was found to be 0.07 mg a.s./l, and the EC100 was found to be 0.22 mg a.s./l

Executive summary:

The short-term toxicity of N,N-Didecyl-N-methylpoly(oxyethyl)ammonium Propionate was determined in a 48 hour acute toxicity semi-static study conducted on Daphnia magna. The study was conducted in accordance with Directive 92/69/EEC, Method C2 and OECD Guideline No. 202. 10 daphnids were placed in duplicate, in each test and control vessel at random in the prepared test solutions. The test vessels were covered to reduce evaporation and maintained at 21°C with a photoperiod of 16 hours light and 8 hours dark. The daphnids were exposed to the test substance at the following concentrations, 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg a.s./l. 100% immobilisation was observed in the 0.7 mg a.s./l and 0.392 mg a.s./l test group after 24 and 48 hour respectively and in the 0.224 mg a.s/l test group after 48 hours. Based on concentration effect relationship observed, the no-observed-effect concentration (NOEC) was found to be 0.0392 mg/l and the EC50 was found to be 0.07 mg a.s./l.

Description of key information

One key study is available to determine the short-term toxicity of Bardap 26 to Daphnia magna. The study was conducted in accordance with Directive 92/69/EEC, Method C2 and OECD Guideline No. 202. The test organisms were exposed to the test material for 48 hours at concentrations of 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg/L. 100% immobilisation was observed in the 0.7 mg/L and 0.392 mg/L test group after 24 and 48 hour respectively and in the 0.224 mg/L test group after 48 hours. Based on concentration effect relationship observed,

the no-observed-effect concentration (NOEC) was found to be 0.0392 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

0.07 mg/L

Additional information

The short-term toxicity of N,N-Didecyl-N-methylpoly(oxyethyl)ammonium Propionate was determined in a 48 hour acute toxicity semi-static study conducted on Daphnia magna. The study was conducted in accordance with Directive 92/69/EEC, Method C2 and OECD Guideline No. 202. 10 daphnids were placed in duplicate, in each test and control vessel at random in the prepared test solutions. The test vessels were covered to reduce evaporation and maintained in at 21°C with a photoperiod of 16 hours light and 8 hours dark. The daphnids were exposed to the test substance at the following concentrations, 0, 0.007, 0.0126, 0.0224, 0.0392, 0.07, 0.126, 0.224, 0.392 and 0.7 mg a.s./l. 100% immobilisation was observed in the 0.7 mg a.s./l and 0.392 mg a.s./l test group after 24 and 48 hour respectively and in the 0.224 mg a.s/l test group after 48 hours. Based on concentration effect relationship observed, the no-observed-effect concentration (NOEC) was found to be 0.0392 mg/l.