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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
19 October 2015 - 11 November 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
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):
- Name of test material (as cited in study report): Amidoamine (UVCB)
- Substance type: Amidoamine
- Chemical name: Glycerides, C14-20, reaction products with diethylenetriamine (preliminary naming)/Amides, from diethylenetriamine and hydrogenated palm oil
- CAS 85409-11-6/1618093-67-6
- Physical state: pale yellowish solid at 20 °C
- Batch No.: K8 4309 L481
- Expiry date of batch: 09 March 2018
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Analytical monitoring:
yes
Details on sampling:
- Concentrations: WAF of 100 mg/l test item
- Sampling method: Samples were taken from the control and the 100 mg/L loading rate WAF from the bulk test preparation at 0 hours and from the pooled replicates (replicates R1 – R4) at 48 hours for quantitative analysis. Samples were stored frozen prior to analysis. Duplicate samples were taken and stored frozen for further analysis if necessary.
Vehicle:
no
Details on test solutions:
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test item. Preliminary work was carried out to determine whether stirring for a prolonged period produced significantly higher measured test concentrations in the WAF. The loading rate to be used in the definitive test was determined by a preliminary range-finding test. In the range-finding test Daphnia magna were exposed to a series of nominal loading rates of 0.10, 1.0, 10 and 100 mg/L.
Prior to addition of the test item a glass siphon tube was placed in the test media. Nominal amounts of test item (20, 20 and 200 mg) were each separately added to the surface of 20, 2.0 and 2.0 liters of test water to give the 1.0, 10 and 100 mg/L loading rates respectively. 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 mixtures allowed to stand for 1 hour. Microscopic observations made on the
WAFs indicated that test item was present dispersed in the water column and hence it was considered justifiable to remove the WAFs 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 1.0, 10 and 100 mg/L loading rate WAFs. Microscopic observations of the WAFs were performed after filtering and showed no micro dispersions present.
Test organisms (species):
Daphnia magna
Details on test organisms:
The test was carried out using 1st instar Daphnia magna derived from Envigo in-house laboratory cultures.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
The reconstituted water had an approximate theoretical total hardness of 250 mg/L as CaCO3.
Test temperature:
The test temperature was controlled at 19 to 22 °C.
pH:
pH of media was measured at 0h and 48h in a range of 8.0 and 8.1.
Dissolved oxygen:
The dissolved oxygen content was greater than or equal to 8.7 mg O2/L.
Nominal and measured concentrations:
Chemical analysis of the fresh test preparation at 0 hours showed a measured test concentration of 0.13 mg/L. Analysis of the aged test preparation at 48 hours showed a measured test concentrations of 0.097 mg/L.
Details on test conditions:
Adult daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room maintaining the water temperature at 18 to 22 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.
Reference substance (positive control):
yes
Key result
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
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
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.

Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading
rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
Results with reference substance (positive control):
A positive control (Study Number 41502271) used potassium dichromate as the reference item. The results from the positive control with potassium dichromate were within the normal range for this reference item.
Reported statistics and error estimates:
An estimate of the EL50 values was given by inspection of the immobilization data.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and gave a 48-Hour EL50 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 (2015) the acute toxicity of amidoamine test item to daphnia was determined in a 48‑hour static limit test according to Part C.2 of the Commission Regulation (EC) No 440/2008 and the OECD Guideline for Testing of Chemicals No. 202 (2004). 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 twenty  daphnids (4 replicates of 5 animals) exposed to a 100 mg/L loading rate WAF for a period of 48 hours. The test was considered to be valid given that all performance criteria were met. The 48‑hour NOELR of the amidoamine test item is greater than 100 mg/l loading rate WAF.

Description of key information

LD50, 48h > 100 mg/l loading rate WAF, value used for CSA

NOAEL, 48h > 100 mg/l loading rate WAF

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

Analogue substance was tested for acute toxicity to aquatic invertebrates (Daphnia) following OECD 203. Under the experimental conditions the LC50, 48h (NOAEL) > 100 mg/l loading rate WAF.

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

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