N,N-Bis(2-hydroxyethyl)-C12-18(even numbered, C18 unsaturated) alkyl-1-amine oxides

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:

18 February - 24 March 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed under GLP and according to guideline with some deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

No measurements of the concentrations. No data on Daphnia culture.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2,2'-iminobis-, N-coco alkyl derivs., N-oxides

EC Number:

263-180-1

EC Name:

Ethanol, 2,2'-iminobis-, N-coco alkyl derivs., N-oxides

Cas Number:

61791-47-7

Molecular formula:

not applicable

IUPAC Name:

N,N-Bis(2-hydroxyethyl)-C12-18(even numbered) alkyl-1-amine oxides

Details on test material:

The test material was identified by name and specifications:
- chemical name: Cocobis(2-hydroxyethyl)amine oxide
- cas nr : 61791-47-7
- batch no: 900110 (CoA attached to the report):
Amine oxide: 30.5%
Free amine: 0.3%
Free peroxide: 0.13%
water: balance
CRL code T90-2-1.5

It was supplied by the study sponsor on 8 Feb 1990. Stored in the dark at room temperature.

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Liquid.
Stable at test concentrations (data on biodegradability available).
Water soluble at test concentrations.

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

The test solutions were prepared from stock solutions of the test substance in deionized water. The stock solution was clear and homogeneous
(some foam was produced but disappeared after a short time). The test concentrations were prepared by addition of the respective amounts of the
stock solution to the DutchStandardWater. For the preparation of the test concentration a stock solution containing 0.3 g/L was used.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna (waterflea) originated from the continuous culture maintained at the research facilities. The animals used in the test were less than
24 hours old at the beginning of the test and were obtained from parent animals having an age of about 3 weeks.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None

Test conditions

Hardness:

13 dH

Test temperature:

19.3 - 19.7 C

pH:

8.0 - 8.1

Dissolved oxygen:

8.8 - 9.1 mg/L

Nominal and measured concentrations:

Nominal concentrations:
0.46 - 1.0 - 2.1 - 4.6 - 10 mg/L

Details on test conditions:

400 mL glass beakers containing 250 mL of test medium were partly covered with a glass plate. Each beaker contained 5 animals. In the control 30
animals were tested, while 20 animals were tested per test concentration.
The diluting water used for the preparation of the test concentrations was a synthetic water: Dutch Standard Water (DSW): ph = 8.2 and a hardness of 13 dH. The test was carried out in a temperature controlled room. The light regime was 16 hours of ambient light per day, supplied by fluorescent
tubes. pH and oxygen concentrations were measured daily.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: 95% CI 0.9-1.3 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI 2.9 - 4.3 mg/L

Details on results:

The NOEC after 48 hours amounted to 0.46 mg/L, whereas 10 mg/L produced 100% immobilization within 48 hours. The EC50 (48h) was calculated
to be 3.5 mg/L with 95% confidence limits of 2.9 - 4.3 mg/L.

Reported statistics and error estimates:

The EC50 was determined with an LC50 programme of Griffioen (RIZA, NL) based on a model of Kooyman (1981).

Any other information on results incl. tables

Number of mobile animals

Conc substance	Test vessel
in mg/l	number	0 hours	24 hours	48 hours
	1	5	5	5
	2	5	5	5
	3	5	5	5
control	4	5	5	5
	5	5	5	5
	6	5	5	5
	total	30	30	30
	1	5	5	5
	2	5	5	5
0.46	3	5	5	5
	4	5	5	5
	total	20	20	20
	1	5	5	5
	2	5	5	4
1.0	3	5	5	5
	4	5	5	5
	total	20	20	19
	1	5	5	5
	2	5	5	5
2.1	3	5	5	4
	4	5	5	5
	total	20	20	19
	1	5	5	1
	2	5	5	0
4.6	3	5	4	1
	4	5	5	3
	total	20	19	5
	1	5	4	0
	2	5	3	0
10	3	5	5	0
	4	5	4	0
	total	20	16	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50(48h) was calculated to be 3.5 mg/L with 95% confidence limits of 2.9 and 4.3 mg/L. The NOEC (48h) was 0.46 mg/L. If it is assumed that the product has a 100% pure active ingredient and that the toxicity is related to the active ingredient only, the EC50 and NOEC (48h) amount to 1.1 and 0.14 mg/L amine oxide respectively.

Executive summary:

A static study was performed according to OECD203 and GLP to investigate the acute toxicity of the test item to the aquatic invertebrate Daphnia magna. Based on nominal concentrations only, the EC50 was calculated to be 3.5 mg/L with 95% confidence limits of 2.9 and 4.3 mg/L. The NOEC after 48h was 0.46 mg/L.