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 aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-03-31 - 2011-04-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction 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 analytical determination of the test substance were taken:
- each time from freshly prepared test medium
- at the time of renewal from old test medium (1 occasion per week)
Duplicate samples were taken from one vessel per concentration (selected randomly).

Vehicle:

no

Details on test solutions:

- Stock solutions prepared by dissolving substance in test medium.
- pH of stock solutions adjusted to ca. 7.0 using 6M HCl.
- Test solutions prepared by dissoving required amount of suitable stock solution in test medium.
- No need to adjust pH of test solutions.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: ID: DM-MBT-071229
- Source: originally supplied by MicroBioTests Inc., and bred in the laboratory of SAPM
- Age of test animals (mean and range, SD): < 24 h old at start of testing, not first brood progeny of parent daphnids
- Feeding during test: yes
- Food type: concentrated suspensions of the unicellular green alga Scenedesmus subspicatus
- Amount: 0.16-0.17 mg C/individual/day
- Frequency: daily

ACCLIMATION
- Acclimation period: daphnids are cultured at the laboratory in Elendt M4 medium, details not reported
- Type and amount of food: concentrated suspensions of Scenedesmus subspicatus, for adults 0.1-0.2 mg organic carbon per adult per day
- Feeding frequency: daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

195-210 mg CaCO3/L

Test temperature:

19.1-20.7°C (water temperature)

pH:

6.81-7.41

Dissolved oxygen:

7.22-10.58 mg/L

Salinity:

not applicable

Nominal and measured concentrations:

Nominal: control + 0.5, 1.26, 3.16, 7.95, 20 mg/L
Measured: control (< LOQ) + within 20% deviation from nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-mL glass beaker, 60 mL fill-volume
- Type (delete if not applicable): open
- Aeration: not during test, test medium aerated for 30 min prior to start of test
- Renewal rate of test solution (frequency/flow rate): 3x/week, i.e. on day 2, 5, 7, 8, 11, 13, 15, 18 and 20
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium prepared using analytical reagents and deionized water
- Total organic carbon: 0.51 mg/L (before addition of algae)
- Culture medium different from test medium: no
- Intervals of water quality measurement: oxygen concentration, temperature, hardness and pH once a week in fresh and old media, in the control and in the highest test concentration

OTHER TEST CONDITIONS
- Adjustment of pH: not needed (only in stock solutions)
- Photoperiod: 16L:8D
- Light intensity: 505 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality, number of live offspring, presence of aborted eggs or dead offspring (monitored 5x/week)

RANGE-FINDING STUDY
- No range-finding study
- Design of study based on outcome of acute testing

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

7.95 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks:

: live offspring per surviving parent

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

13.51 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks:

: live offspring per surviving parent

Remarks on result:

other: 95% CI = 10.39-16.63 mg/L

Details on results:

21-d LOEC (reproduction) = 20 mg/L
Mortality in the control was 10% and mean number of live offspring per surviving parent animal was 66 (passing validity criteria).
Mortality in treatment groups varied from 10 to 50%, but there was no significant correlation between concentration and response.

Reported statistics and error estimates:

NOEC and LOEC: one-way ANOVA & Bonferroni Test
EC50 and 95% CI: regression analysis (using SYSTAT 13)

Validity criteria fulfilled:

yes

Conclusions:

This 21-d Daphnia magna reproduction test with the substance resulted in a NOEC, LOEC and EC50 of 7.95, 20, and 13.51 mg/L, respectively, based on the number of live offspring per surviving parent animal. It is a slight disadvantage that the EC50 lies between the NOEC and the LOEC, but the results of the test can be considered reliable. No concentration response relationship was obtained for mortality, but mortality may have been affected by handling stress in some of the lower test concentrations. The fact that only the reproduction of the parent animals surviving the complete test were taken into account avoids any affect of this mortality on the reproduction-based EC50.

Description of key information

A 21-d Daphnia magna reproduction test with the substance resulted in a NOEC, LOEC and EC50 of 7.95, 20, and 13.51 mg/L, respectively, based on the number of live offspring per surviving parent animal (Li et al., 2011).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

7.95 mg/L

Additional information

It is a slight disadvantage that the EC50 lies between the NOEC and the LOEC, but the results of the test can be considered reliable. Although some mortality was observed, no concentration response relationship was obtained; mortality may have been affected by handling stress in some of the lower test concentrations. The fact that only the reproduction of the parent animals surviving the complete test were taken into account avoids any affect of this mortality on the reproduction-based EC50.