Amines, (2-ethylhexyl)(hydrogenated tallow alkyl)methyl

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:

September 2, 2016 to February 21, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

1078712-76-1

Molecular formula:

C23-27H49-59N (Substance is a UVCB)

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Test water samples were collected from the batches of test solution prepared for each treatment and
control group at the beginning of the test and from each test chamber at 48 hours (± 1 hour) to measure
concentrations of the test substance. Ten milliliter aliquots of all the samples were collected from mid-depth,
placed in glass vials containing 10.0 mL of 0.2% formic acid in methanol, and processed immediately for
analysis.

Test solutions

Vehicle:

no

Details on test solutions:

The test substance was administered to the test organisms in water. This route of administration was
selected because it represents the most likely route of exposure to aquatic organisms. Since the test substance
is poorly soluble in water, individual test solutions were prepared in the form of water accommodated
fractions (WAF) for each loading rate of 1.9, 4.3, 9.4, 21, 45 and 100 mg/L in a 4.5 L Pyrex™ aspirator with
tubulation and spigot approximately 2-3 cm from the bottom. 4-L of dilution water was measured using a
calibrated plastic bucket and emptied into labeled WAF bottles. For each loading rate, an appropriate amount
of the test material was weighed onto plastic weigh boats and then was rinsed with a portion of the dilution
water into the appropriate WAF bottles. Each test solution was stirred on a stir plate with a Teflon-lined stir
bar, with a vortex depth of approximately 30% of the test solution height for 23 hours. The negative control
was dilution water only.

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

140 mg/L as CaCO3

Test temperature:

20 +/- 1 C

pH:

8.1-8.5

Dissolved oxygen:

> 8.2 mg/L

Conductivity:

336 uS/cm

Nominal and measured concentrations:

Nominal WAF Loading Rates
Negative Control
1.9 mg/L
4.3 mg/L
9.4 mg/L
21 mg/L
45 mg/L
100 mg/L

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

1.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: lethargy

Any other information on results incl. tables

Results of analyses to measure concentrations of Amines, (2-ethylhexyl)(hydrogenated tallow

alkyl)methyl in the test solutions samples collected during the test are presented in Table 1. Measured

concentrations from day 0 and 48 hour sample analysis ranged from approximately < LOQ to 1.07% of

nominal. When measured concentrations of the samples collected during the test were averaged, the mean

measured test concentrations for this study were 0.01, 0.02, 0.03, 0.02, 0.16 and 0.07 mg/L, representing 0.53,

0.47, 0.32, 0.10, 0.36 and 0.066% of nominal loading rates, respectively. Since the test substance is poorly

soluble in water, the individual test solutions prepared as water accommodated fractions (WAF) for each

loading rate were all above the solubility limit of the test substance. The resulting measured concentrations

were variable, but essentially equivocal despite differences in loading rate, and incorporating a lengthy

mixing procedure. Therefore, the results of the study were interpreted based on the nominal loading rates.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes