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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2012-01-31 to 2012-02-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study. GLP.
Justification for type of information:
Read across to the analogous substance.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Read across is based on structural and physico chemical similarity of 1,4BDDMA and 1,3-BDDMA (see attached document)
Common mechanism in aquatic toxicity: narcosis. No specic toxicity against aquatic organisms is expected.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Substance name 1,4-Butanediol dimethacrylate 1,3-Butanediol dimethacrylate

EC-Number 218-218-1 214-711-0
CAS-Number 2082-81-7 1189-08-8

Purity: 90-100 % Purity: 90-100 %
Reactive ester content: >= 98 % Reactive ester content: >= 98 %
1,4-Butane diol, CAS 110-63: 0-1 % 1,3-Butane diol, CAS 107-88-0 0-1 %
Methyl methacrylate, CAS 80-62-6: 0-1 % Methyl methacrylate, CAS 80-62-6 0-1 %
4-Methoxyphenol, CAS 150-76-5 0.009 – 0.011 % 4-Methoxyphenol, CAS 150-76-5 0.018 – 0.022 %


3. ANALOGUE APPROACH JUSTIFICATION
see attached document
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Version / remarks:
adopted 23 March 2006
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
The concentrations of the test item were analytically determined from all test concentrations and the control after 0 hours (test start) and 72 hours (test end). Samples at test start were taken from an additional replicate without algae. At end of the test samples were taken directly from the pooled test replicates.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
stock solution: 100 mg/L, freshly prepared with dilution water.
The stock solution was treated with ultrasound for 15 min and stirred with approximately 1100 rpm for 1 h at room temperature.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Strain: Desmodesmus subspicatus CHODAT SAG 86.81
- Source (laboratory, culture collection): Sammlung von Algenkulturen (SAG), Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, 37073 Göttingen, Germany
- Age of inoculum (at test initiation): four day old preculture, prepared in dilution water, was used as inoculum


ACCLIMATION
- Acclimation period: no data
- Culturing media and conditions (same as test or not): according to the guideline (OECD 201 medium)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Test temperature:
21-22°C
pH:
initial: 7.80 to 7.98
final: 7.90 to 8.19
Nominal and measured concentrations:
nominal: 1.00, 2.50, 6.25, 15.6, 39.1 mg/L
measured (geometric mean) 0.828, 2.11, 5.81, 14.9, 38.7 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Sterile Erlenmeyer flasks, capacity: 250 mL, sealed with cotton wool plugs, fill volume 100 mL
- Aeration: agitation, Test containers were placed on a rotary shaker and oscillated at approximately 70 rpm
- Initial cells density: 4910 cells/mL
- Control end cells density: mean 910499 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes, OECD 201 medium

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: 24 hours/day light
- Light intensity and quality: mean 66.3 µE/m²/s (CV 4.62%)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Cell density was measured daily via Chlorophyll-a- fluorescence,excitation at 436 nm, emission at 685 nm

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.5
- Range finding study
- Test concentrations: 0.01, 0.10, 1.00, 10.00, 100.00 mg/L
- Results used to determine the conditions for the definitive study:
Growth inhibition 100% at 100.00 mg/L, 45% at 10.00 mg/L, 0% at 1.00 mg/L, 1% at 0.10 mg/L, 0% at 0.01 mg/L
Yield inhibition 100% at 100.00 mg/L, 86% at 10.0 mg/L, 1% at 1.00 mg/L, 4% at 0.10 mg/L, -1% at 0.01 mg/L
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
2.11 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
4.35 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% c.i. 4.07 – 4.64 mg/L
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
9.79 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% CL: 9.45 – 10.1 mg/L
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
2.11 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
3.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: 95% c.i. 2.61 – 3.71 mg/L
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
4.97 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: 95% CL: 4.54 – 5.25 mg/L
Results with reference substance (positive control):
- Results with reference substance valid?
- ErC50: 0.488, 95 % confidence interval: 0.466 – 0.512 / valid range: 0.699 ± 0.471
- EyC50: 0.291, 95 % confidence interval: 0.274 – 0.328 / valid range: 0.318 ± 0.147
Reported statistics and error estimates:
EC10-, EC20- and EC50-values of the growth rate and yield inhibition after 72 hours were calculated by sigmoidal dose-response regression. Calculation of the confidence intervals EC10-, EC20- and EC50-values were carried out using standard procedures.

Mean cell densities [cells/mL] during the final test:

Geometric mean measured test item concentration[mg/L]

Exposure time [h]

0

24

48

72

38.7

4910

4482

3956

2549

14.9

4910

12648

16298

17750

5.81

4910

18862

74093

319196

2.11

4910

20545

155280

931757

0.828

4910

23711

164036

969172

Control

4910

25319

171447

910499

  

Growth rate, yield during the final test: 

Geometric mean measured test item concentration [mg/L]

Growth rate [/d]

Rate-related inhibition [%]

Yield [cells/mL]

Inhibition of yield [%]

38.7

0

100

0

100

14.9

0.427

75.5

12840

98.6

5.81

1.39

20.2

314286

65.3

2.11

1.75

-0.46

926847

-2.35

0.828

1.76

-1.21

964262

-6.48

control

1.74

905589

Validity criteria fulfilled:
yes
Conclusions:
In this study 1,4-BDDMA was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours.
The NOEC, EC10 and EC50 values based on growth rate were 2.11 mg/L, 4.35 (95% c.i. 4.07 – 4.64) mg/L and 9.79 (95% c.i. 9.45 – 10.1) mg/L, respectively.  The % growth inhibition in the treated algal culture as compared to the control ranged from -1.21 to 100.
The NOEC, EC10 and EC50 values based on yield were 2.11 mg/L, 3.10 (95% c.i. 2.61 – 3.71) mg/L and 4.97 (95% c.i. 4.54 – 5.25) mg/L, respectively.
The effect values given are based on the geometric mean measured concentrations of the test item.
Executive summary:

The toxicity to aquatic algae 1,3 -BDDMA was assed by read across with structurally very similar substance 1,4 -BDDMA on structural analog approach.

In a 72 hour acute toxicity study, the cultures of Desmodesmus subspicatus CHODAT SAG 86.81were exposed to 1,4-BDDMA at measured concentrations of 0 (control),0.828, 2.11, 5.81, 14.9 and 38.7 mg/L under static conditions in accordance with the OECD guideline 201 (adopted 23 March 2006). 

The NOEC, EC10 and EC50 values based on growth rate were 2.11 mg/L, 4.35 (95% c.i. 4.07 – 4.64) mg/L and 9.79 (95% c.i. 9.45 – 10.1) mg/L, respectively.  The % growth inhibition in the treated algal culture as compared to the control ranged from -1.21 to 100.

The NOEC, EC10 and EC50 values based on yield were 2.11 mg/L, 3.10 (95% c.i. 2.61 – 3.71) mg/L and 4.97 (95% c.i. 4.54 – 5.25) mg/L, respectively

 

Microscopic evaluation of the cells at start and end of the incubation period revealed no morphological abnormalities.

 

Results Synopsis

 

Test Organism: Desmodesmus subspicatus CHODAT SAG 86.81

Test Type: Static

 

72 hr ErC50: 9.79 mg/L              95% C.I.: 9.45 – 10.1 mg/L

72 hr EyC50: 4.97 mg/L             95% C.I.: 4.54 – 5.25 mg/L

72 hr ErC10: 4.35 mg/L              95% C.I.:  4.07 – 4.64 mg/L

72 hr EyC10:  3.10 mg/L             95% C.I.:  2.61 – 3.71 mg/L

72 hr NOEC: 2.11 mg/L              

Endpoint(s) Effected:  growth rate, yield

Description of key information

The 72 h EC10 of the structural analogue 1,4-BDMA in freshwater algae was 4.35 mg/L. The 72 h EC50 of 1.4-BDDMA in freshwater algae was 9.79 mg/L.

Key value for chemical safety assessment

EC50 for freshwater algae:
9.79 mg/L
EC10 or NOEC for freshwater algae:
4.35 mg/L

Additional information

One study in freshwater algae is available for the structural analogue 1,4-BDDMA, which is considered reliable without restriction (Klimisch score 1).

In a 72 hour acute toxicity study, the cultures of Desmodesmus subspicatus CHODAT SAG 86.81were exposed to 1,4-BDDMA at measured concentrations of 0 (control), 0.828, 2.11, 5.81, 14.9 and 38.7 mg/L under static conditions in accordance with the OECD guideline 201 (adopted 23 March 2006). 

Microscopic evaluation of the cells at start and end of the incubation period revealed no morphological abnormalities.

The NOEC, EC10 and EC50 values based on growth rate were 2.11 mg/L, 4.35 mg/L and 9.79 mg/L, respectively.