2-[(3-aminopropyl)methylamino]ethanol

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:

2006-12-13 to 2007-04-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

results presented are based on nominal concentrations, no analytical verification of test concentrations performed

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Test Item Name: 2-[(3-Aminopropyl) methylamino]ethanol
- Label Identification: XTA-758
- Batch Number: PFW060026
- Expiration date of the lot/batch: not provided
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage Conditions: Ambient
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: definitive test: concentrations of 100, 150, 225, 338 and 506 mg test substance/L in three replicates of each test concentration, with ten organisms per replicate.
- Method: range-finding test: concentrations of 1, 10, 100, 500, and 1000 mg test substance/L, with 5 organisms per concentration.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no data

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow Trout
- Source: Trout Lodge Trout Farm (Sumner, WA), 21 nov 06, unknown, Star Prairie Trout Farm (Star Prairie, WI), 16 jan 07, 10 nov 06)
- Length at study initiation (length definition, mean, range and SD): the longest fish was not more than twice the lengh of the shortest
- Weight at study initiation (mean and range, SD): range-finding test: Less than 3.0g at dosing
- Feeding during test: no

ACCLIMATION
- Acclimation period: all fish were held in the laboratory at least 14 days before they were used for testing. The fish were held in water of the quality used in the test for at least 7 days immediately before testing.
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily untilll 48 hours before the test was started
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

40-180 mg/L CaCO3

Test temperature:

12 °C

pH:

pH at the start (after 0 hours): 7.7-10.7
pH at the end (after 96h): 7.9-9.0

Dissolved oxygen:

dissolved oxygen at the start (after 0 hours): 9.4-10 mg/L
dissolved oxygen at the end (after 96h): 7.6-9.0 mg/L

Salinity:

not relevant

Conductivity:

245-390 µmhos/cm

Nominal and measured concentrations:

Range-finding test
Nominal concentrations: 1.0, 10, 100, 500 and 1000 mg/L

Final test
Nominal concentrations: 100, 150, 225, 338 and 506 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria
- Material, size, headspace, fill volume: glass, 2.5 gallon
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): no, static test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): no
- Biomass loading rate: max loading of 0.8 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO Medium Ingredients. Moderately hard synthetic freshwater with total hardness of 40-180 mg/L CaCO3 and a pH of 6.0-8.0

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light to 8-hour dark cycle

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: 1.5
- Range-finding study: yes
- Test concentrations: 1.0, 10, 100, 500 and 1000 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

315.65 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% C.L.: 294.39-338.46 mg/L

Details on results:

- Behavioural abnormalities: no abnormalities in the control and the concentration 100 mg/L.
- Mortality of control: no
- Other adverse effects control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Reported statistics and error estimates:

The NOEC and LC50 were determined by a commercially available statistical program (ToxCalc Version 5.0). Several models are available for LC50 determination: Probit, Trimmed Spearman-Karber and Linear Interpolation. The most appropriate model was selected for the determinination in this case.

Validity criteria fulfilled:

yes

Conclusions:

In a valid, reliable and conclusive study according to the approved protocol SOPs and OPPTS, series 850, section 1075, the effect of the test item on the mortality of Rainbow trout after 96 hours was determined. Under the conditions of the present study, the test item had no acute toxic effects on Rainbow trout in a static 96-hour test up to the nominal concentration of 225 mg/L (NOEC). The 96-h LC50 was determined to be 315.65 mg/L with 95% confidence interval of 294.39 - 338.46 mg/L. The results of the test can be considered reliable without restriction. It can be concluded that the test item 2-[(3-Aminopropyl) methylamino]ethanol is not hazardous to fish.

Description of key information

The study of Rodrigue (2007), investigating the acute toxicity of the test substance in rainbow trout according to the approved protocol SOPs and OPPTS, series 850, section 107, was considered as the key study for endpoint coverage. The 96-h LC50 was determined to be 315.65 mg/L (> 100 mg/L). Based on the results it can be considered that the test item is not harmful to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

315.65 mg/L