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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2012-01-11 to 2012-02-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The toxic effect of narcosis is related to the hydrophilicity/hydrophobicity of a substance and correlates with its log Kow.
For the read across approach of the endpoint long term toxicity to aquatic invertebrates 3 methacrylates were used for the approach. 2 of them have the same log kow as BDGMA (log Kow = 3.1) which are 1,4-BDDMA and BNMA. Additionally a third substance was used to tighten the approach. (EGDMA with log Kow = 2.4).
In comparison of the data of the aquatic toxicity of the 4 substances fish is the most sensitive species in contact with BDGMA.: LC50 fish = 22.36 mg/l, EC50 daphnia = 94.7 mg/l .
According to the document 87/2015 of Umweltbundesamt Germany, “Comparison of species sensitivity of Daphnia and fish in acute and chronic testing”, fish testing in long term tests is required for substances being 5 x sensitive to fish than daphnia.
The factor daphnia/fish of the few available data of BDGMA is 4.24 which is less than the above mentioned factor of 5 for which a long term test whit fish is required.
No short term tests are available for daphnia magna of the read across substances 1,4-BDDMA and BNMA. For these both substances EC50 data in algae are slightly lower but in the same order of magnitude as fish acute data.
EC50 based on mortality in long term daphnia magna test (21D) of 1,4-BDDMA and BNMA are higher than EC50 fish short term toxicity.
For EGDMA the difference in the sensitivity of the species fish and daphnia is fish is less lower. (factor daphnia/fish = 2.30).
In the hazard assessment the differences in the species should be considered by using an appropriate assessment factor of 100.

Data matrix see in attached document
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
adopted 3 October 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
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 toxicity of BDGMA was assessed based on read across with 1,4 -BDDMA no specific toxic effect is expected and toxicity is expected to be based on narcosis which correlates with log Kow. Log Kow of both substances is 3.1.

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 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

 

NOEL: 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

Description of key information

EC10 daphnia magna reproduction = 7.51 mg/l (analogy with 1,4-Butanediol dimethacrylate)

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
7.51 mg/L

Additional information

EC10 21 d to daphnia magna (reproduction) of the structurally related substance Ethyltriglycol methacrylate was 77.1 mg/l. Aquatic toxicity of the most methacrylates is known to be based on narcosis which correlates with log Pow.

There are data on 21d daphnia magna reproduction available for two methacrylates with the same log Pow of 3.1 as for Butyldiglycol methacrylates.

EC10 daphnia magna (21d) for Benzyl methacrylates is 3.34 mg/l (Ibacon 2012) and EC10 daphnia magna (21d) for 1,4 Butanediol dimethacrylates is 7.51 mg/l (Noack 2012). As 1,4 -Butanediol dimethacrylate has structurally higher correlation with Butyldiglycol methacrylate than Benzyl methacrylate, 7.51 mg/l will be used for PNEC derivation.