Amines, di-C12-18-alkylmethyl

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:

April 06 to June 15, 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was performed following OECD Guideline 202 and it was GLP certified. However, the maximum effect concentration was 50% of immobilization (with a measured concentration of 0.02 mg/L of test substance). Therefore, only an estimation of the EC50 by calculation was possible using the available data. The validity criteria have been fulfilled. Taking into account these elements, a reliability of 2 has been given to this study.

Justification for type of information:

There is no information of Amines, di-C12-18-alkylmethyl (CAS No.: 68439-75-8; EC No.: 270-418-8) itself but there is information available for 1-Decanamine, N-decyl, N-methyl (CAS No.: 7396-58-9; EC No.: 230-990-1) which is structurally similar to Amines, di-C12-18-alkylmethyl.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

As the test item water solubility was supposed to be very low, it was decided to prepare a solution of the test item in an organic co-solvent. This solution was prepared by dissolving 1 g of test item in 20 mL of acetone. Preliminary and definitive stock solutions were prepared by mixing 100 µL of the acetone solution in 1 L of dilution water, corresponding to a final nominal concentration of 5 mg/L.

For the range finding test, a stock solution at 5 mg/L was prepared 20 hours before the beginning of the test by mixing 5 mg of the test item (100µl aceton solution) in 1 litre of dilution water. After decantation, it was used to prepare the convenient range of nominal concentrations : 5, 2.5, 1, 0.5, and 0.1 mg/L.

For the definitive test a stock solution at 5 mg/L solution was prepared the same way and used to prepare the convenient range of nominal concentrations : 0.1, 0.05, 0.025, 0.0125 and 0.0063 mg/L.

Test organisms (species):

Daphnia magna

Details on test organisms:

Biological reagent: organisms Daphnia magna Straus (Cladocera, Crustacea), clone 5 or clone A. Animals come from a stock breeding in the laboratory reared in VOLVIC® water added with vitamin B12, Na2SeO3, 5H2O, calcium and magnesium salts and fed with unicellular green fresh-water algae Pseudokirchneriella subcapitata and Chlorella Vulgaris. Selection of test organisms less than 24 hours-old is made by filtration.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

pH:

7.59 to 8.1 depending on flask content analyzed and timing

Dissolved oxygen:

8.4 to 9.4 depending on flask content analyzed and timing

Nominal and measured concentrations:

Nominal and measured concentrations of the test item at the beginning and at the end of the exposure period

Concentration of 1-DECANAMINE, N-DECYL, N-METHYL
Nominal concentrations mg/L Initial (mg/L) Final (mg/L) Final/Initial% Extrapolated*(mg/l)
0.1 0.019 0.024 126 0.02
0.05 0.010 0.013 130 0.01
0.025 0.013 0.006 0
< DL : concentration lower than the Detection Limit of the analytical method (0.0024 mg/L).
< QL : concentration lower than the Quantification Limit of the analytical method (0.0079 mg/L).
* Extrapolated concentration with geometric average value of initial and final concentrations. When final concentration is lower than DL or QL, half the values of DL or QL are used for the calculation.

Details on test conditions:

The study was performed in a temperature-controlled room using 30 mL glass bottles stoppered with PTFE bungs and sealed with aluminium caps. The temperature, continuously recorded in one test flask, remained constant at 19.6 ± 1.3 °C. Physical-chemical parameters were measured using a METTLER TOLEDO 345 pH-meter for measurement of pH and with a WTW OXI 538 oxymeter for dissolved oxygen measurement.

Water: ultra-pure water was used for the preparation of dilution water (resistivity > 18MΩ).

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.024 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.004 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

The sensitivity of the test system and the methodology are evaluated every month by performing an inhibition test on potassium dichromate. The nearest value of EC50 obtained on 15/05/2010 was 0.98 mg/L
For reference, ISO 6341 has a validity criteria specifying that EC50 must be in the range 0.6 to 2.1 mg/L.

Reported statistics and error estimates:

The inhibition of mobility data are analyzed using an Excel program. It was designed to calculate the EC50 value and the 95% confidence interval. Probit analysis is generally used to calculate the 24 and 48-hours EC50 values.

Validity criteria fulfilled:

yes

Conclusions:

The study was performed in compliance with the following quality criteria:

· The immobilisation in the control did not exceed 10 per cent at the end of the test;
· Daphnids in the control were not trapped at the surface of the water;
· The dissolved oxygen concentration remained above 3 mg/L over the test period.

Executive summary:

The acute toxicity (inhibition of mobility) of the test item 1-DECANAMINE, N-DECYL, N-METHYL for a duration of 48 hours was assessed according to the OECD Guideline 202.

Daphnia magna were exposed under static conditions to a range of concentrations of 1-DECANAMINE, N-DECYL, N-METHYL dissolved in dilution water. The toxic effect measured during the assay was the inhibition of mobility over time periods of 24 and 48 hours.

The maximum effect concentration was 50% of immobilization, corresponding to a measured concentration of 0.02 mg/L. Therefore, only an estimation of the EC₅₀

value by calculation was possible.

The results were as follows:

Duration of exposure period	EC50Value, mg/L	NOEC, mg/L
24h	> 0.02	ND
48h	0.024	0.004

ND: not determined

Description of key information

Based on read-across to 1-DECANAMINE, N-DECYL, N-METHYL, a substance with the same chemical structure, but a shorter alkyl chain length than the substance registered, EC50 value to invertebrates is 0.024 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.024 mg/L

Additional information

The acute toxicity (inhibition of mobility) of the test item 1-DECANAMINE, N-DECYL, N-METHYL for a duration of 48 hours was assessed according to the OECD Guideline 202.

Daphnia magna were exposed under static conditions to a range of concentrations of 1-DECANAMINE, N-DECYL, N-METHYL dissolved in dilution water. The toxic effect measured during the assay was the inhibition of mobility over time periods of 24 and 48 hours.

The maximum effect concentration was 50% of immobilization, corresponding to a measured concentration of 0.02 mg/L. Therefore, only an estimation of the EC50 value by calculation was possible.

The results were as follows:

Duration of exposure period	EC50Value, mg/L	NOEC, mg/L
24h	> 0.02	ND
48h	0.024	0.004

ND: not determined