reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy)but-2-ylamine

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish, juvenile growth test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-03-10 - 2011-04-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 215 (Fish, Juvenile Growth Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): XTJ 568
- Chemical name: monoethyleneglycol, polybutyleneoxidediamine
- Molecular formula: C10H24N2O2
- Appearance: clear liquid
- Lot/batch No.: HSMX20110211-0184
- Receipt date: 2011-02-15
- Purity: 90%
- Storage condition of test material: in original container (plastic bottle with lid) at 4°C

Analytical monitoring:

yes

Details on sampling:

Samples for analysis of actual test substance concentration (2 mL) were taken from each test vessel at the start of testing and at weekly intervals thereafter.

Vehicle:

no

Details on test solutions:

- 10 g/L master stock solution prepared using deionized water.
- pH of master stock solution adjusted to ca. 7.0 using 6M HCl.
- Series of stock solutions with lower concentrations prepared by dilution of master stock solution with test water.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Strain: ID: BR-MKT-110308
- Source: obtained from Shanghai Xiexing Aquarium
- Age at study initiation (mean and range, SD): not reported (juvenile)
- Length at study initiation (length definition, mean, range and SD): not reported
- Weight at study initiation (mean and range, SD): 0.09 +/- 0.01 g
- Feeding during test: yes
- Food type: same as during acclimation
- Amount: 4% of body weight per day (based on initial fish weights, revised after 14 days)
- Frequency: twice a day, two feedings separated by 6 h, food withheld 24 h prior to weighing

ACCLIMATION
- Acclimation period: fish were kept in the laboratory for more than 14 days prior to testing
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Brine Shrimp Aquarium Flake Food and live food of brine shrimp (both O.S.I.)
- Feeding frequency: twice a day
- Health during acclimation (any mortality observed): no diseases observed, no mortalities within 7 days prior to testing

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Hardness:

165-170 mg CaCO3/L

Test temperature:

22.0-22.9°C

pH:

7.23-7.95

Dissolved oxygen:

60.3-100.0% of ASV

Salinity:

not applicable

Nominal and measured concentrations:

Nominal: control + 1.6-5.0-16-50-120 mg/L
Mean measured: < LOQ + 1.32-4.78-14.63-42.92-110.09 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 5-L glass tanks
- Type (delete if not applicable): open
- Aeration: yes, continuously
- Type of flow-through (e.g. peristaltic or proportional diluter): peristaltic
- Renewal rate of test solution (frequency/flow rate): 6 L renewal per day (flow rate 4.17 mL/min)
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: ca. 0.2-0.3 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water, dechlorinated by activated carbon and sterilized by UV irradiation
- Total organic carbon: 621.0 µg/L
- Particulate matter: 1.30 mg/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: water hardness (once in controls and one vessel at highest concentration), pH, dissolved oxygen and temperature were measured weekly
- Uneated food and faeces removed from test vessels daily through suction

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12L:12D

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality (daily), and growth (representative samples of test fish weighed at start of testing, all survivors weighed at end of testing)

TEST CONCENTRATIONS
- Range finding study: no
- Results used to determine the conditions for the definitive study: results from acute test were used

Reference substance (positive control):

no

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 110.09 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: no significant difference at highest test concentration compared to control

Key result

Duration:

28 d

Dose descriptor:

EC50

Effect conc.:

> 110.09 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

28-d LOEC > 110.09 mg/L
No mortalities were observed during the test.

Reported statistics and error estimates:

NOEC and LOEC: one-way ANOVA.
EC50: Linear Interpolation method.
Software used: TOXCALC v5.0.26.

Validity criteria fulfilled:

yes

Conclusions:

This 28-d juvenile growth inhibition test with zebra fish (Danio rerio) did not reveal any adverse effects on fish growth at any of the concentrations tested. When expressed as mean measured test substance concentration, the NOEC, LOEC and EC50 can be considered >= 110.09, > 110.09 and > 110.09 mg/L, respectively. No mortalities were observed throughout the test.

Description of key information

A 28-d juvenile growth inhibition test with zebra fish (Danio rerio) did not reveal any adverse effects on fish growth at any of the concentrations tested. When expressed as mean measured test substance concentration, the NOEC, LOEC and EC50 can be considered >= 110.09, > 110.09 and > 110.09 mg/L, respectively. No mortalities were observed throughout the test (Li et al., 2011)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

110 mg/L