Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study, although only limit test study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

For the determination of the actual test item concentrations, duplicate samples were taken from each treatment before the start of the test, after 48 hours and at the end of the test after 96 hours.

All samples were taken from the approximate center of each aquarium without mixing the test medium, and were stored deep-frozen (at about -20 °C) immediately after sampling.

The concentrations of the test item RL277/09 were determined in all test medium samples from all sampling times. From the control samples, only one of the duplicate samples was analyzed per sampling time.

Details on test solutions:

Test Water:
Reconstituted test water was used in the study. It consisted of analytical grade salts dissolved in purified water. The ratio of Ca:Mg and Na:K was 4:1 and 10:1, respectively, based on molarity. The test water was aerated prior to the preparation of the test medium until oxygen saturation was reached.

Test Medium:
At the start of the test, the test medium of nominal 251.3 mg test item/L (corresponding to 101 mg dry matter/L) was prepared by mixing 1256.6 mg of the test item into 5 liters of test water using ultrasonic treatment for 15 minutes and intense stirring for 15 minutes at room temperature. The test medium was freshly prepared just before introduction of the fish (= start of the exposure).

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Source: The fish were obtained from a breeding culture at Harlan Laboratories.
Medication: No medication was applied during holding and acclimatization.
Acclimation: Prior to test start, the test fish were acclimated for one week to the test water and temperature.
Feeding: During holding and acclimatization until one day before the start of the test, the fish were fed with a commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49304 Melle / Germany).

During the last two weeks prior to the test, no fish died in the test fish batch and all fish were healthy.

Length and weight: From the acclimated test fish batch, 10 fish were measured at the start of the test. The mean body length of the fish was 3.1 ± 0.13 cm (Mean ± SD), the mean body wet weight was 0.21 ± 0.04 g (Mean ± SD).

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

The test fish were observed for mortality and visible abnormalities after approximately 3, 24, 48, 72 and 96 hours test duration.

Test temperature:

The water temperature in the test vessels was maintained at 20 °C.

pH:

The pH value in all treatments was between 7.5 and 7.6

Dissolved oxygen:

The oxygen concentration was always 8.4 mg/L or higher, and thus higher than 60% oxygen saturation.

Nominal and measured concentrations:

251.3 mg test item/L (corresponding to 101 mg active substance/L)

Details on test conditions:

The test vessels were slightly aerated during the test period.

A 16-hour light to 8-hour dark photoperiod, with a 30-minute transition period was used (light intensity during the light period was approximately within the range of 100 to 480 Lux).

Feeding: The fish were not fed during the test.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 251.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: which equates to > 101 mg active substance/L

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

251.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 101 mg active substance/L

Details on results:

A limit test was performed in accordance with the guidelines to demonstrate that the test item has no toxic effect on the test organisms at the nominal concentration of 251.3 mg test item/L (corresponding to 101 mg active substance/L). all fish survived until the end of the test and no visible abnormalities were observed at the test fish.

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour LC50 was ≥251.3 mg test material/L (>101 mg active substance/L). The test item had no acute toxic effects on zebra fish up to the nominal test item concentration of 251.3 mg test material/L (101 mg active substance/L), based on a limit test study.

Executive summary:

In a 96-h acute toxicity study, zebrafish (Danio rerio) were exposed to the substance at one measured concentration of 251.3 mg test material/L (101 mg active substance/L) under static conditions in a limit test.  The 96-h LC₅₀was >251.3 mg test material/L (>101 mg active substance/L), based on mortality. This toxicity study is classified as acceptable and satisfies the guideline requirement for short-term toxicity study for fish.

Description of key information

Elementis Specialities (2009) reports an LC50 for short term toxicity in fish of >251.3 mg test material/L (101 mg active substance/L).

A reliable short-term toxicity study with fish has been conducted on the test material and is included in this dossier.

 

Elementis Specialities (2009) conducted a reliable (Klimisch 1) GLP compliant study following OECD 203 methods with the test material. Zebrafish (Danio rerio) were exposed to the test substance in a limit test at one nominal concentration of 251.3 mg test material/L (101 mg/L active substance) for 96 hrs under static conditions. The 96-h LC50 was >251.3 mg test material/L (>101 mg active substance/L), based on mortality. Consequently this value will be taken as the short-term toxicity in fish endpoint for the substance.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

251.3 mg/L