Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

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:
2012-01-11 to 2012-02-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study OECD 211, GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
adopted 3 October 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
certificate dated 2010-10-20
Analytical monitoring:
yes
Details on sampling:
1,4-BDDMA was analytically verified by HPLC-DAD in the fresh media (0 h) and old media (48 h) of all tested concentration levels and the control at least once every 7 days. For the old media additionally prepared replicates with test media but without daphnids and algae were prepared and incubated under test conditions until sampling. Additional sampling was done on days 19 and 21 due to the findings in the fresh media of the second sampling interval.
Vehicle:
no
Details on test solutions:
The stock solution (40.0 mg/L test item was weighed out) was freshly prepared with dilution water. The stock solution was treated with ultrasound for 30 min and stirred with approximately 2 hours at room temperature.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna STRAUS (Clone 5)
- Justification for species other than prescribed by test guideline: Daphnia magna is the preferred species in accordance with the test guideline and is bred at the test facility
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Age of parental stock (mean and range, SD): 2 to 24 h old daphnids were used for the study. They were obtained by removing the mother animals twice within 22 h.
- Feeding during test
Daily. Per test vessel Pseudokirchneriella subcapitata (0.582 - 1.85 mL) and Desmodesmus subspicatus (0.509 - 0.850 mL) suspension was provided as food corresponding to 0.2 mg Carbon per Daphnia and day. Variation was according to the density of the algae suspension, but was the same for all test groups on each feeding day.

ACCLIMATION
- Acclimation period: At least 2 h in dilution water
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
144 to 174 mg CaCO3/L
Test temperature:
19.0 to 20.9°C
pH:
initial: 7.68 to 7.80 in the geometric mean measured concentration of 30.8 mg/L; 7.83 to 8.40 in control
final: 7.54 to 7.81 in the geometric mean measured concentration of 30.8 mg/L; 7.52 to 7.89 in control
Dissolved oxygen:
7.75 to 11.34 mg/L
Nominal and measured concentrations:
Nominal: 1.02, 2.56, 6.40, 16.0, 40.0 mg/L
Measured: 0.635, 1.81, 5.09, 13.5, 30.8 mg/L (corresponding to mean recovery rates of 62 to 84 % of the nominal values).
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (5 (ID) x 8 (H) cm), 100 mL capacity, fill volume 50 mL
- Renewal rate of test solution (frequency/flow rate): Semi-static, medium renewal 3 times per week, i.e. after 48 and 72 h, respectively
- 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, modified to a total hardness of 160 to 180 mg CaCO3/L.
- Intervals of water quality measurement: once within 7 days, in fresh and old media, in one replicate of the control and the highest concentration of the test item

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: Max. 20 µE/m²/s
- ‘test temperature: 18 - 22°C, ± 1°C constant

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality of parental daphnids (immobile or dying) – daily
Condition of parental daphnids:
Abnormalities (e.g. swimming behaviour, number of males and winter eggs) were observed and recorded at each day of observation.
Total length and dry body weight of parental daphnids:
At the end of the test total length of each daphnid and dry body weight of the daphnids alive at each concentration level and the control was determined.
Number of offspring (alive and dead progeny) - daily
neonates (alive and dead) were removed after counting
dead specimens were removed
number of aborted eggs and dates of observation were recorded.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
5.09 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
13.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
7.51 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 95 % confidence limits: 3.81 – 9.44 mg/L
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
14.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 95 % confidence limits: 12.2 – 16.3 mg/L
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
15.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
parents
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
22.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
parents
Remarks on result:
other: confidence limits: 13.5 – 30.8 mg/L
Duration:
21 d
Dose descriptor:
other: EC90
Effect conc.:
30.8 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
parents
Results with reference substance (positive control):
The EC50 of the reference item at 1.69 mg/L (95% confidence limits: 1.64 - 1.73 mg/L) after 24 hours is within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.
Reported statistics and error estimates:
see section "Any other information on results"

Effects

Geometric Mean Measured Concentration of
1,4-BDDMA [mg/L]

 

Control

0.635

1.81

5.09

13.5

30.8

Mean Number of Living Juveniles per

Producing Parent (Reproduction Rate±SD)

133±13

127±22

136±24

128±41

72±171)

0±01)

Coefficient of Variation of the Mean Number of Juveniles per Producing Parent [%]

10

 17

18

322)

24

n.d.

Percentage of Dead Juveniles Related to the Total Number of Juveniles [%]

 0

  1

 1

 2

 11

1003)

Mean Intrinsic Rates of Natural Increase

 0.49

  0.47

 0.48

 0.45

 0.351)

01)

Appearance of First Brood [Mean Day]

 8.2

  8.3

 8.2

 8.8

12.64)

n.d.

Mean Number of Broods

 4.90

  4.80

 4.90

 4.70

  2.905)

n.d.

Adult Mortality after 21 Days [%]

10

 0

 0

 0

 0

906)

Parent Animals: Mean Dry Weight [mg]

 0.94

 1.00

 0.90

 1.09

 1.03

---

Parent Animals: Mean Body Length [mm]

 5.25

 5.58

 5.43

 5.60

 5.00

  3.00

SD= Standard deviation

1)   =Statistical significance (One Way Analysis of Variance, Dunnett’s method,p 0.001)

2)   = Significant variation between the test replicates (Coefficient of variation > 25 %)

3)   = Biologically significant

4)   = 1st brood significantly delayed (after day 10) at several daphnids

5)   = Less than four broods released by several daphnids

6)   = Significant adult mortality (> 20 %)

No males and ephippia were observed in the control or in the test groups.

Validity criteria fulfilled:
yes
Conclusions:
The reduction of the reproductive output was the most sensitive effect in this study. The No Observed Effect Concentration (NOECReproduction) after 21 days was assessed at 5.09 mg/L. The Lowest Observed Effect Concentration (LOECReproduction) was assessed at 13.5 mg/L. The EC10-value for the reduction of the reproductive output was calculated by sigmoidal dose-response regression to be 7.51 mg/L (95 % confidence limits: 3.81 – 9.44 mg/L). The EC50-value for the reduction of the reproductive output was calculated to be 14.1 mg/L (95 % confidence limits: 12.2 – 16.3 mg/L).
The EC10-value for the adult mortality was calculated by sigmoidal dose-response regression to be 15.5 mg/L. The EC50-value was calculated to be 22.1 mg/L (confidence limits: 13.5 – 30.8 mg/L).
Executive summary:

The 21-day-chronic toxicity of 1,4-BDDMA to Daphnia magna Straus was studied under static renewal conditions according to OECD guideline 211 (adopted 3 October 2008). Daphnids were exposed to control and test chemical at measured concentrations of 0 (control), 0.635, 1.81, 5.09, 13.5 and 30.8 mg/L

The 21 day EC50 based on mortality was 22.1 mg/L. The 21 day EC50 based on reproductive effects was 14.1 mg/L. The 21 -d EC10 based on reproduction was 7.51 mg/L (95 % c.l. 3.81 – 9.44 mg/L). The 21-day NOEC based on reproduction was 5.09 mg/L.

The sublethal effects included were reproduction rate and appearance of first brood. Production of offspring in the treated groups indicated that 1,4-BDDMA had an effect on the reproduction at concentrations greater than 5.09 mg/L. The most sensitive end point was the reduction of the reproductive output.        

 

Results Synopsis

 

Test Organism Age (e.g. 1st instar): 2 to 24 h old daphnids

Test Type: Static renewal

 

NOEC: 5.09 mg/L

EC10: 7.51 mg/L         95 % confidence limits: 3.81 – 9.44 mg/L

LOEC: 13.5 mg/L                    Endpoint(s) Effected: reproduction

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Description of key information

The 21 d EC10 of 1,4-BDDMA in freshwater invertebrates based on reproduction was 7.51 mg/L. The 21 d-NOEC based on reproduction was 5.09 mg/L (OECD guideline 211, static renewal).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
7.51 mg/L

Additional information

One long-term study in freshwater invertebrates is available for 1,4-BDDMA, which is considered reliable without restriction (Klimisch score 1).

The 21-day-chronic toxicity of 1,4-BDDMA to Daphnia magna Straus was studied under static renewal conditions according to OECD guideline 211 (adopted 3 October 2008). Daphnids were exposed to control and test chemical at measured concentrations of 0 (control),0.635, 1.81, 5.09, 13.5 and 30.8 mg/L

The 21 day EC50 based on mortality was 22.1 mg/L. The 21 day EC50 based on reproductive effects was 14.1 mg/L. The 21 -d EC10 based on reproduction was7.51 mg/L.The 21-day NOEC based on reproduction was 5.09 mg/L.

The sublethal effects included were reproduction rate and appearance of first brood. Production of offspring in the treated groups indicated that 1,4-BDDMA had an effect on the reproduction at concentrations greater than 5.09 mg/L. The most sensitive end point was the reduction of the reproductive output.