Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 April to 20 October 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyoeisha Chemical Co. Ltd./ Bx 6021874
- Expiration date of the lot/batch: 18 february 2019
- Purity test date: 18 february 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in original container away from heat or sunlight.
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)

OTHER SPECIFICS:
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
- other information:

Analytical monitoring:

yes

Remarks:

It will be difficult due to the very low water soulbilty

Details on sampling:

0, 24 and 48 hours

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 100 mg of Reaction mass N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide was transferred into a 10 mL volumetric flask and the volume was made up with DMF, this was sonicated for 1 h and then centrifuged at 14000 rpm for 10 minutes to obtain the nominal concentration of 10.0 mg/mL (stock A). A 10 µL volume (Stock A) was transferred using a micropipette and diluted to 100 mL with reconstituted water in glass beakers of 600 mL capacity to obtain the nominal test concentration of 1.0 mg Reaction mass N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/L.
- Eluate: DMF
- Differential loading:
- Controls: For the vehicle control, 10 µL of DMF diluted to 100 mL with reconstituted water in glass beakers of 600 mL capacity was used.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
- Other relevant information:

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: no data
- Justification for species other than prescribed by test guideline: Daphnia magna was selected as the test system because it plays an important role as a food chain organism. It has high sensitivity to chemicals in the aquatic ecosystem and is recommended by the OECD and other regulatory authorities. The results of the study are valuable in predicting the acute toxicity of the test item in aquatic ecosystems.
- Age at study initiation (mean and range, SD): <24h
- Weight at study initiation (mean and range, SD): n/a
- Length at study initiation (length definition, mean, range and SD): 48h
- Stage and instar at study initiation: 2nd instar
- Method of breeding: Parthenogenesis
- Source: Laboratory of Ecotoxicology, Jai Research Foundation
- Age of parental stock (mean and range, SD):
- Feeding during test no
- Food type: live algal cells (Pseudokirchneriella subcapitata).
- Amount:
- Frequency:

ACCLIMATION
- Acclimation period: 48h
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: live algal cells (Pseudokirchneriella subcapitata).
- Feeding frequency:
- Health during acclimation (any mortality observed): no mortality

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

Standard study duration.

Post exposure observation period:

No

Hardness:

140 and 250 mg/L as CaCO3

Test temperature:

20 ± 2 °C

pH:

6.0 to 9.0

Dissolved oxygen:

≥ 3 mg/L in control and test vessels

Salinity:

N/A

Nominal and measured concentrations:

currently less than the water solubility of < 0.00022 mg/L

Reference substance (positive control):

yes

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

ca. 0 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: limit of water solubility

Validity criteria fulfilled:

yes

Conclusions:

LD50 is < 0.00022 mg/L due to the limit of solubility, no effects observed.

Description of key information

LD50 is < 0.00022 mg/L due to the limit of solubility, no effects observed at the limit of water solubilty

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0 mg/L