3-butoxypropylamine

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:

2018-01-08 to 2018-02-23

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:

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:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PFW160573
- Expiration date of the lot/batch: 2018-09-26
- Purity: 99.39%
- Physical state/Appearance: clear colourless liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data

Analytical monitoring:

yes

Details on sampling:

- Sampling method:
* Definitive Test: Samples were taken for analysis and stored frozen at 0 and 72 hour (fresh media) and 24 and 72 hour (old media). Duplicate samples, and samples at 24 hour (fresh media), 48 hour (fresh and old media) and 72 hour (old media) were taken and stored frozen should any further analysis be required.
- Sample storage conditions before analysis: All samples were stored frozen prior to analysis

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
A nominal amount of test item (280 mg) was dissolved in test water and the volume adjusted to 1 liter to give the 280 mg/L stock solution from which a dilution was made to give the test concentration of 14 mg/L. The pH of the 280 mg/L stock solution was adjusted in the range of 7.4 to 7.7 prior to use.
The stock solution was inverted several times to ensure adequate mixing and homogeneity.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All solutions were clear and colourless.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Length at study initiation (length definition, mean, range and SD): mean: 4.7 cm (standard deviation = 0.3)
- Weight at study initiation (mean and range, SD): mean: 0.85 g (standard deviation = 0.11)
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 7 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

approximately 140 mg/L as CaCO3

Test temperature:

14 °C

pH:

7.2-8.0

Dissolved oxygen:

9.4-11.5

Salinity:

not relevant

Conductivity:

not indicated

Nominal and measured concentrations:

Final test:
Nominal concentrations: 14 mg/L
Measured concentrations (mg/L) at t=0h (fresh): Measured concentrations (mg/L) at t=24h (old): 0.000915, 13.5
Measured concentrations (mg/L) at t=72h (fresh): 0.000997, 14
Measured concentrations (mg/L) at t=96h (old): 0.00123, 13.9

Nominal and measured concentrations Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentration only

Details on test conditions:

TEST SYSTEM
- Test vessel: exposure vessels
- Material, size, headspace, fill volume: 25-30 L, all-glass filled with 20L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported
- Biomass loading rate: 0.30 g fish/L

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none (limit test)
- Range finding study: no
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 14 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- 96-h NOEC = 14 mg/L

Reported statistics and error estimates:

An estimate of the LC50 values was given by inspection of the mortality data.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test substance to Rainbow trout was determined in a 96 hour static limit test according to the OECD guideline 203. Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so the results are based on nominal test concentrations only. Under the conditions of the present study, the 96-h LC50 exceeded the nominal concentration of 14 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

In accordance with the recommendations of REACH, the test was conducted according to the threshold approach recommended by ECHA.  Using this approach the lowest EC50 value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold concentration and a “Limit test” is conducted at this threshold concentration.  If no mortalities are observed this indicates that fish are not the most sensitive species and that the LC50 is greater than the threshold concentration.  The EC50 value obtained from the Algal Growth Inhibition study (Envigo study number KT80PH) was the lowest of these two EC50 values and hence the test was conducted at a single concentration of 14 mg/L.

The acute toxicity of the test substance to Rainbow trout was determined in a 96 hour semi-static limit test according to the OECD guideline 203 (Squance, 2018). Under the conditions of the present study, the 96-h LC50 exceeded the nominal concentration of 14 mg/L, so no EC50 could be derived.