Reaction mass of reaction products of octadecanoic acid, 12-hydroxy with ethylenediamine

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

(the temperature varied by ± 1.25°C during the study, thus being slightly above the accepted variation. However, this was considered not to have affected either the integrity or validity of the study.)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

(the temperature varied by ± 1.25°C during the study, thus being slightly above the accepted variation. However, this was considered not to have affected either the integrity or validity of the study.)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: nominal 100 mg/L and control
- Sampling intervals: start and end of the renewal periods
- Sampling method: two samples (50 mL) were taken from each vessel of the freshly prepared (0 and 72 hours) and expired (24 and 96 hours) control and test media.
- Sample storage conditions before analysis: no storage prior to analysis

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fractions (WAFs)
In duplicate, the test substance was added to dilution water (dechlorinated and softened tap water) in an aspirator, and then made up to volume (30 L) whilst magnetically stirring. The bulk preparation was stirred for approximately 24 hours in the dark and then left to stand for approximately 24 hours in the dark. An aliquot (21 L) of the mid-vessel content was syphoned into a fish tank (the first litre of medium having been discarded), to give a 20 L aliquot of Water Accommodated Fraction (WAF) which was used as test medium with a nominal loading rate of 100 mg/L.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source:commercial fish farm in the UK
- Length at study initiation: 6.3-7.8 cm
- Weight at study initiation: 3.52 g (mean wet weight)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial fish food (TROUW (UK) Ltd. Nutra Fry 02); amount equivalent to 1% of the total wet-weight of fish in the holding tank; no food was given during the 24-hour period immediately before exposure.
- Health during acclimation: no mortality, no medication

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

control: 153 mg/L as CaCO3
treatment: 140mg/L as CaCO3

Test temperature:

13.45°C ± 1.25°C (continuously monitored in one control and one treatment vessel).
Although the temperature was slightly outside the specification of ± 1°C during the study this deviation from guidelines was considered not to have affected either the integrity or validity of the study.

pH:

7.4-8.0

Dissolved oxygen:

80-105% air saturation value

Nominal and measured concentrations:

nominal loading rate: 100 mg test material/L
mean measured TOC levels in fresh media: 1.5 mgC/L
mean measured TOC levels in expired media (24 h): 0.85-0.99 mgC/L
overall geometric mean value: 1.2 mgC/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria, containing 20 litres of medium
- Type: open
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.88 g body weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated and softened by passage through a water purification system consisting of activated carbon filter, water softener and reverse osmosis treatment.
Total organic carbon: 1.1 mg C/L
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 hours dark with periods of subdued lighting at the beginning and end of each light phase

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects; recorded at approx. 2, 4, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study
- Test concentrations: nominal loading rates 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no mortality or treatment-related effects were noted after 96 hours

Reference substance (positive control):

not required

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)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and sub-lethal effects

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

- Other biological observations: none
- Mortality of control: zero
- Other adverse effects control: none

The test medium was a grey hazy emulsion.

Reported statistics and error estimates:

The “no observed effect loading rate” (NOELR) was derived by direct inspection of the data for lethal and sub-lethal effects. An incidence rate of more than one fish out of ten was considered to be significant.

Validity criteria fulfilled:

yes

Remarks:

mortality of control animals <10%; concentration of dissolved oxygen in all test vessels >60% saturation

Description of key information

96-h LL50 (based on loading rates) >100 mg/L for Oncorhynchus mykiss (OECD TG 203, EU C.1)

Additional information

The results indicate that the test material is not toxic to fish up to the limits of its water solubility (<1 mg/L) and a NOEC and thus a PNEC cannot be determined.