4,4-Dimethyl-2-undecyl-2-oxazoline

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12th June 2017 - 4th December 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP, Guidelines : OECD 202

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole

EC Number:

686-853-5

Cas Number:

46921-17-9

Molecular formula:

C16H31NO

IUPAC Name:

4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole

impurity 1

Reference substance name:

Unknown impurities

IUPAC Name:

Unknown impurities

impurity 2

Reference substance name:

IUPAC name not applicable

Molecular formula:

C16H33NO2

IUPAC Name:

IUPAC name not applicable

impurity 3

Reference substance name:

IUPAC name not applicable

Molecular formula:

C28H55NO3

IUPAC Name:

IUPAC name not applicable

Test material form:

liquid

Specific details on test material used for the study:

Purity : 88,0% / Storage conditions : stored in closed cabinet away from light at room temperature (15-25°C).

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Five daphnies were exposed in 50 mL solution of each replicate to fives concentrations up to water solubility limit : 0.003 – 0.0075 – 0.015 – 0.045 – 0.075 – 0.15 mg/L in test media.

Test solutions

Vehicle:

yes

Details on test solutions:

The test item stock solutions (water solubility level) were prepared by dissolution of about 5 mg of Lauryl Oxazoline in 1000 mL of the test media. The solution were prepared in 2 L glass bottle and shacked during about 24h. Then this preparation were decanted at about 5 minutes in separating funnel and filtered through 0.2 μm filter. This solution was used as water
solubility level and diluted in media to prepare several dilutions. The pH of these solutions were in the range 8.0-8.1. Test media solution pH was between 6 and 9 considered as appropriate for a normal life of test organisms.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna Straus. Daphnids less than 24 hours old and produced from parthenogenically reproducing brood female population. Origin : Culture at SGS Multilab Rouen.

Study design

Test type:

semi-static

Water media type:

freshwater

Remarks:

reconstituted from salts

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

Lauryl Oxazoline were quantified at t0, t24h and t48h. Number of immobilized daphnids was recorded after 24h and 48h in all replicates.

Post exposure observation period:

Not applicable

Test conditions

Test temperature:

19.6 to 19.9°C. The test was carried out in a thermostatic chamber at 20°C +/- 2°C in the dark (temperature was recorded automatically by Evisense Temperature Center).

pH:

Test media solution pH was between 6 and 9 considered as appropriate for a normal life of test organisms. pH variation in the test (pH units) : 0.1 (Criteria : ≤ ± 1.5).

Dissolved oxygen:

Dissolved oxygen at T48h (mg/L) : 7,9 (Criteria : ≥ 3).

Nominal and measured concentrations:

Nominal concentrations:
The definitive test was performed with five concentrations up to water solubility limit (SL) and with a dilution factor of 2 (SL, SL/2, SL/4, SL/8, SL/16).
SL = 0,500 mg/L ;
SL/2 = 0,250 mg/L ;
SL/4 = 0,125 mg/L ;
SL/8 = 0,0625 mg/L
SL/16 = 0,03125 mg/L

Meaured concentrations T0 (mg/L) :
SL = 0.531
SL/2 = 0.270
SL/4 = 0.119
SL/8 = 0.058
SL/16 = 0.030

Meaured concentrations T24h before renewal (mg/L) :
SL = 0.269
SL/2 = 0.135
SL/4 = 0.049
SL/8 = 0.027
SL/16 = 0.010

Meaured concentrations T24h after renewal (mg/L) :
SL = 0.490
SL/2 = 0.243
SL/4 = 0.123
SL/8 = 0.062
SL/16 = 0.031

Meaured concentrations T48h (mg/L) :
SL = 0.289
SL/2 = 0.155
SL/4 = 0.082
SL/8 = 0.034
SL/16 = 0.016

Details on test conditions:

- Test vessels : 125mL glass flask
- Type : open
- Aeration : Slightly aerated
- No. of organisms per vessels : 5
- No. of vessels per concentration (replicate) : 4
- No. of vessels per control : 4
- Photoperiod : light/dark cycle 16/8 hours
- Source/preparation of dilution water : prepared as described in OECD 202 test guideline

Reference substance (positive control):

yes

Remarks:

potassium dichromate (99,99%)

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Remarks:

and EC10

Effect conc.:

ca. 0.106 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

(see tables below section : "any other information on results incl. tables")

Reported statistics and error estimates:

(see tables below section : "any other information on results incl. tables")

Any other information on results incl. tables

Toxicity data at 24h (*5 daphnids per replicate)

	Daphnids immobilised per replicate*
Nominal concentration (mg/L)	replicate A	replicate B	replicate C	replicate D	Total of immobilised daphnids	percentage of immobilisation
Control	0	0	0	0	0	0
SL	1	2	2	3	8	40
SL/2	1	0	2	2	5	25
SL/4	0	0	0	0	0	0
SL/8	0	0	0	1	1	5
SL/16	0	0	0	0	0	0

 

Toxicity data at 48h (*5 daphnids per replicate)

	Daphnids immobilised per replicate*
Nominal concentration (mg/L)	replicate A	replicate B	replicate C	replicate D	total of immobilised daphnids	percentage of immobilisation
Control	0	0	0	0	0	0
SL	5	5	5	5	20	100
SL/2	4	3	4	5	16	80
SL/4	2	3	3	2	10	50
SL/8	0	0	0	1	1	5
SL/16	0	0	0	0	0	0

Statistic and error estimates :

EC50 -48h and confidence limits Probit calculation table :

Test item Geometrical mean (mg/L)	Log(C)=x	% immobilised (P)	EP	Y	w	Nw	Nwx	Nwx2
0.377	-0.4237	100	-	7.1	0.110	2.20	-0.93	0.395
0.192	-0.7167	80	5.84	6.0	0.439	8.78	-6.29	4.510
0.088	-1.0555	50	5.00	4.7	0.616	12.32	-13.0	13.73
0.043	-1.3665	5	3.36	3.5	0.269	5.38	-7.35	10.05
0.020	-1.6990	0	-	2.2	0.025	0.50	-0.85	1.443

m	-0.976
s	0.262
EC50 -48h (mg/L)	0.106
SNw	29.2
SNwx	-28.4
SNWx2	30.1
SE approximative	0.0118
Log SE	0.0485
SE	0.0118
Confidence Limit >95% (mg/L)	0.1175
Confidence Limit <95% (mg/L)	0.0939

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Ecotoxicity test of Lauryl Oxazoline on Daphnia magna fulfils the requirements of OECD test No. 202 to determine EC50-48h = 0.106 mg/L [0.094 - 0.117] mg/L.

Executive summary:

Objective :

The scope of this study was, in compliance with the principles of Good Laboratory Practices (GLP), to determine the acute toxicity of Lauryl Oxazoline on Daphnia magna in a 48-hours test.

 

Method Summary :

Five daphnids were exposed in 50 mL solution of each replicate at fives concentrations up to water solubility limit. Four replicates were performed including control. Number of immobilised daphnids was recorded after 24h and 48h in all replicates.

	Lauryl Oxazoline BPL16 -0047.001 Based on measured concentrations
EC50 -48h [Confidence limit 95%]	0.106 mg/L [0.094 - 0.117] mg/L
EC10 -48h [Confidence limit 95%]	0.049 mg/L [0.043 - 0.054] mg/L

ECX-48h: Effective Concentration corresponding to X% of mobility inhibition in the 48 -hours test

Conclusion :

Ecotoxicity test of Lauryl Oxazoline on Daphnia magna fulfils the requirements of OECD test No. 202 to determine EC50-48h = 0.106 mg/L [0.094 - 0.117] mg/L.