Fatty acids, C16-18, reaction products with diethylenetriamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

other: read acro0ss from analogue substance

Adequacy of study:

key study

Study period:

4 December 2014 - 25 January 2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test item without emulsifier was investigated.

Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
Physical state: pale yellowish solid at 20 °C
Batch No.: K8 4309 L481
Expiry date of batch: 09 March 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Analytical monitoring:

yes

Details on sampling:

- Concentrations: WAF of 100 mg/l test item
- Sampling method: For the determination of the actual test item concentrations in this semi-static test, duplicate samples were taken.
Water samples were taken from the control and the 100 mg/L loading rate WAF test vessel at 0 and 72 hours from fresh media and at 24 and 96 hours from old media for quantitative analysis. The samples were stored frozen prior to analysis.

Duplicate samples and samples at 24 (fresh media), 48 (old and fresh media) and 72 hours (old media) were taken and stored frozen for further analysis if necessary.

The method of analysis, recovery and test preparation analyses are described in the study report.

Vehicle:

no

Details on test solutions:

Prior to addition of the test item a glass siphon tube was placed in the test media. An amount of test item (2200 mg) was added to the surface of 22 liters of test water to give the 100 mg/L loading rate. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixture allowed to stand for 1 hour. Visual observations made on the WAF indicated that a significant amount of dispersed test item was present in the water column and hence it was considered justifiable to remove the WAF by filtering through a glass wool plug (2-4 cm in length). A length of Tygon tubing was attached to the top of the glass siphon tube. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75-100 mL discarded) to give the 100 mg/L loading rate WAF. Microscopic observations of the WAF were performed after filtering and showed no micro-dispersions of test item to be present. The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0, 24, 72 and 96 hours.

Preliminary investigational work indicated that there was no increase in the amount of dissolved test item when the preparation period was extended for longer than 24 hours. Therefore, for the purpose of testing the WAF was prepared using a stirring period of 23 hours followed by a 1-Hour settlement period.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The test was carried out using juvenile rainbow trout. Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK and maintained in-house since 07 October 2015. Fish were maintained in a glass fiber tank with a "single pass" water renewal system. Fish were acclimatized to test conditions from 9 to 16 November 2015. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. These parameters were recorded daily. The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test. There were no mortalities in the 7 days prior to the start of the test and the fish had a mean standard length of 4.4 cm (sd = 0.3) and a mean weight of 1.1 g (sd = 0.22) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.37 g bodyweight/liter. The diet and diluent water are considered not to contain any contaminant that would affect the integrity and outcome of the study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener) giving water with a total hardness of approximately 140 mg/L as CaCO3.

Test temperature:

The water temperature was controlled at 13 to 14 °C.

pH:

pH of fresh media was measured at 0h, 24h, 48h, 72h in a range of 7.5 and 7.7.
pH of old media was measured at 24h, 48h, 72h and 96h in a range of 7.5 and 7.7.

Dissolved oxygen:

The dissolved oxygen content was greater than or equal to 9.8 mg O2/L.

Nominal and measured concentrations:

Chemical analysis of the fresh test preparations at 0 and 72 hours showed measured test concentrations of 0.086 and 0.017 mg/L. Analysis of the old test media at 24 and 96 hours showed measured test concentrations of 0.013 and 0.020 mg/L.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

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)

Details on results:

The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
There were no lethal and sub-lethal effects of exposure observed in 7 fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours.
The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was greater than or equal to 60% of ASV (6.1 mg O2/L) in the control and test vessels.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test item to the freshwater fish rainbow trout has been investigated using the threshold approach and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.

Executive summary:

In the Klimisch 1 GLP study from Sacker (2016) the acute toxicity of amidoamie test item to juvenile rainbow trout was determined in a 96‑hour semi-static limit test with daily test medium renewal according to Part C.1 of the Commission Regulation (EC) No 440/2008 and the OECD Guideline for Testing of Chemicals No. 203 (1992). Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF). The nominal test item concentration tested was 100.0 mg/L. Additionally, a control group was tested in parallel.

There were no lethal and sub-lethal effects of exposure observed in 7 fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours. The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was greater than or equal to 60% of ASV (6.1 mg O2/L) in the control and test vessels. The 96‑hour NOELR of the amidoamine test item isgreater than 100 mg/l loading rate WAF.

Description of key information

LD50, 96h > 100 mg/l loading rate WAF, value used for CSA

NOAEL, 96h > 100 mg/l loading rate WAF

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Analogue substance was tested for acute toxicity to fish following OECD 203. Under the experimental conditions the LC50, 96h (NOAEL) > 100 mg/l loading rate WAF.

Based on the read across considerations same results apply to Stearamide DETA