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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 9, 2016 to February 22, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 203 (Fish, Acute Toxicity 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:

Water samples were collected from each test chamber of each treatment and control group at the beginning and end of the first renewal and last renewal periods of the test to determine concentration of test substance. Newly prepared test solutions in each test chamber were sampled at 0 and 72 hours (± 1 hour), and
the 24-hour old solutions in the test chambers were sampled at 24 and 96 hours (±1 hour). Ten milliliter aliquots of 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 substanceis poorly soluble in water, individual test solutions were prepared in the form of water accommodated fractions (WAF) for each loading rate of 6.3, 13, 25, 50 and 100 mg/L in 13.2 L Pyrex™ aspirators with tubulation and spigot approximately 2-3 cm from the bottom. Dilution water was pre-measured and emptied into labeled WAF bottles. For each loading rate, appropriate amounts of the test material were weighedand then rinsed with a portion of the dilution water into the appropriate WAF bottles. Each test solution was then stirred on a stir plate with a Teflon-lined stir bar for 23 hours, with a vortex depth of approximately 30% of the test solution height. The negative control was prepared in exactly same manner as the test solutions, but with dilution water only and no test substance. Due to the large amounts of oil droplets on the surface of the water in the 100 mg/L test solution, two batches of test solution were prepared. A small volume (approximately 5.5 L) was used from each batch in an effort to avoid allowing the large oil droplets into the test chamber when decanting.

At the beginning of the stirring process, the solutions in the WAF bottles appeared as follows. The negative control test solution appeared clear and colorless, while the 6.3, 13 and 25 mg/L solutions appeared clear and colorless with oil droplets on the water surface. The 50 and 100 mg/L WAF solutions appeared
translucent and colorless with increasing oil on the surface. The solutions were allowed to settle for approximately 1 hour to allow phase separation before decanting the aqueous phase. After the settling period and prior to decanting into the test chambers, the solutions in the WAF bottles appeared as follows. The
negative control appeared clear and colorless. The 6.3 and 13 mg/L WAF solutions appeared clear and colorless with a few oil droplets on surface. The 25, 50 and 100 mg/L WAF solutions appeared clear and colorless with many oil droplets on the surface, increasing in size (and stuck to the inside of the WAF bottle) with increasing concentration. Care was taken to avoid decanting the oil droplets on the water surface of the WAF solutions, that included the solutions being filtered through glass wool (placed in the spigot tubing) while decanting into their appropriate test chamber.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

144 mg/L as CaCO3

Test temperature:

13 +/- 1 C

pH:

8.0-8.2

Dissolved oxygen:

> 7.9 mg/L

Conductivity:

346 usS/cm

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

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

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

concentrations from day 0, 24, 72 and 96 hour sample analysis ranged from approximately 0.022 to 18% of

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

measured test concentrations for this study were 0.51, 0.17, 0.17, 0.65 and 0.23 mg/L, representing 8.1, 1.3,

0.68, 1.3 and 0.23% 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