1-methyltrimethylene dimethacrylate

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:

2020-10-28 to 2020-11-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD 211, GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

Version 2012

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

The test item concentration of 1,3-Butanediol dimethacrylate were analytically verified in 3 intervals during the test via GC-MS in fresh media at the start of the exposure-renewal intervals on days 0, 9, 14 (0 hours) and in the old media at the end of the exposure intervals on days 2, 12, 16 (48 and 72 hours, respectively) in all concentration levels (with surviving daphnids) and in the control.

Vehicle:

no

Details on test solutions:

An appropriate amount of the test item was weighed out and transferred into a measuring flask with an appropriate amount of dilution water. The stock solution was stirred for 30 minutes (1100 rpm, room temperature) with a magnetic stirrer. The stock solution was used for the preparation of the test concentrations by dilution with the dilution water.

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): <24 h old daphnids were used for the study. To achieve this, juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded.
- Feeding during test
The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus. The algae are cultured at the test facility.



ACCLIMATION not necessary

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

The total hardness was above 140 mg/L as CaCO3.

Test temperature:

The temperature was within the range of 20 ± 2 °C.

pH:

The pH-values should be in the range of 6 – 9. Significant deviations ≥ 1.5 units between the initial and final pH-values were not observed.

Dissolved oxygen:

The dissolved oxygen concentration was above 3 mg/L.

Nominal and measured concentrations:

Nominal: 3.42 - 7.51 - 16.5 - 36.4 - 80.0 mg/L
Measured: 2.81 – 6.26 – 13.8 – 31.6 – 74.6 mg/L

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.

Key result

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

9.87 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: 95% CI: 9.50 – 10.2 mg/l

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

17.1 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: 95% CI: 16.7 – 17.4 mg/l

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

13.8 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

6.26 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LC50

Effect conc.:

48.6 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

other: Adult mortality

Remarks on result:

other: 95% CI: 31.6 – 74.6 mg/l

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

74.6 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

other: Adult mortality

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

31.6 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

other: Adult mortality

Details on results:

- Behavioural abnormalities:
- Observations on body length and weight:
- Other biological observations:
- Mortality of control:
- Other adverse effects control:
- Immobilisation of control:
- Abnormal responses:
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
- Effect concentrations exceeding solubility of substance in test medium:

Effects on Reproduction for all Survived Parents

(based on the time-weighted mean measured concentrations of the test item)

Time-weighted mean measured test item concentrations [mg/L]	Mean number of offspring persurvived parental daphnid
	Mean	SD	CV
74.6	0	0	Not applicable
31.6	7.40	4.12	55.6
13.8	67.0	29.4	43.9
6.26	101	33.8	33.6
2.81	115	22.7	19.8
Control	97.1	15.1	15.5

 

 

Mortality [%] of the Adult Daphnids after 7, 14 and 21 Days of Exposure

(n = 10)

Time-weighted mean measured test item concentrations [mg/L]	Adult Mortality [%]
	7 days	14 days	21 days
74.6	100	100	100^1)
31.6	0	0	0
13.8	0	0	10
6.26	0	10	10
2.81	0	0	10
Control	0	0	0

¹⁾= statistically significant (Step‑down Cochran-Armitage Test Procedure,α = 0.05)

 

Intrinsic Rates of Natural Increase

 

Time-weighted mean measured test item concentrations [mg/L]	Mean Intrinsic Rate	CV
	MV±SD	[%]
74.6	Not applicable
31.6	0.179 ± 0.0563	31.5
13.8	0.332 ± 0.0346	10.4
6.26	0.379 ± 0.0220	5.80
2.81	0.387 ± 0.0289	7.5
Control	0.390± 0.0160	4.1

 

 

First Appearance of Living Juveniles in the Individual Groups

 

Time-weighted mean measured test item concentrations [mg/L]	Day of first appearance of living juveniles at the survived parental daphnids in replicate no.										First appearance (mean day)
	1	2	3	4	5	6	7	8	9	10
74.6	--	--	--	--	--	--	--	--	--	--	Not applicable
31.6	8	8	8	8	8	8	8	8	8	8	8.0
13.8	7	8	8	10	8	8	7	8	8	8	8.0
6.26	7	8	8	7	7	7	8	8	7	9	7.6
2.81	7	9	7	8	8	7	8	7	8	8	7.7
Control	7	7	7	7	7	7	8	7	7	7	7.1

--  = not applicable, since no living juveniles occurred

 

Stillborn Juveniles and Aborted Eggs produced by the Survived Parental Daphnids
after 21 Days

 

Time-weighted mean measured test item concentrations [mg/L]	Number of		Total no.   Sum
	stillborn juveniles	aborted eggs
74.6	0	0	0
31.6	169	1	170
13.8	170	52	222
6.26	0	4	4
2.81	0	5	5
Control	0	0	0

 

 

Total Body Length and Dry Weight of the Survived Parental Daphnids

Time-weighted mean measured test item concentrations [mg/L]	Total length of the survived parent animals [mm]										MV	N	Dry weight [mg]
	Replicate no.
	1	2	3	4	5	6	7	8	9	10	[mm]		S	MV
74.6	--	--	--	--	--	--	--	--	--	--	--	--	--	--
31.6	3.5	3.5	3.0	3.5	3.5	3.5	3.0	3.5	4.0	3.5	3.45	10	1.40	0.14
13.8	4.5	4.5	4.0	4.0	--	4.0	4.0	4.0	5.0	4.0	4.22	9	4.20	0.47
6.26	5.0	4.5	4.5	4.5	4.0	4.5	4.5	4.0	4.0	--	4.39	9	5.60	0.62
2.81	4.5	4.5	4.5	4.5	4.5	5.0	4.5	4.5	--	5.0	4.61	9	6.20	0.69
Control	4.5	4.5	4.5	4.5	4.5	4.5	5.0	5.0	4.0	4.5	4.55	10	6.40	0.64

N = number of the survived parental daphnids

--  = not applicable, due to the mortality of the parental daphnid(s)

 

 

Nomales and ephippiawere observed in the control or in the test groups.

Validity criteria fulfilled:

yes

Conclusions:

The effects on reproduction were evaluated based on the reproduction per introduced parent animal, since this parameter is the ecologically most relevant response variable and is required by the OECD test guideline 211 (2012), when a significant trend in mortality is detected.
A summary of the assessed effect levels based on the time-weighted mean measured concentrations of the test item 1,3-Butanediol dimethacrylate is given above.
The overall effect threshold for effects of the test item under the test conditions was 6.26 mg/L (NOEC) and 13.8 mg/L (LOEC) based on the time-weighted mean measured concentrations of the test item 1,3-Butanediol dimethacrylate.

Executive summary:

Daphnia magna reproduction test (semi-static, 21 d) of the test item1,3-Butanediol dimethacrylate was carried out under semi-static conditions with a medium renewal three times per week. Nominal concentrations of the test item 1,3-Butanediol dimethacrylate were selected based on the results of a preliminary range finding test (non-GLP) as follows: 3.42 - 7.51 - 16.5 - 36.4 - 80.0  mg/L (separation factor 2.2) which corresponds to the time-weighted mean measured test item concentrations of: 2.81 – 6.26 – 13.8 – 31.6 – 74.6 mg/L.

The effects on reproduction were evaluated based on the reproduction per female parent animal inserted at the start of the exposure. The Step-down Cochran-Armitage test revealed a significant trend in mortality. Thus, according to OECD 211 it is required to report the effect values for the cumulative offspring per survived parent provided these values are lower than in the cumulative offspring per introduced parent.

The 21 day LC50 based on mortality was 48.6mg/L. The 21 day EC50 based on reproductive effects was 17.1 mg/L. The 21 day EC10 based on reproduction was 9.87 mg/L (95 % CI. 9.5 – 10.2 mg/L). The 21-day NOEC based on reproduction was 6.26 mg/L.

The sublethal effects included were intrinsic rate of the natural increase, the number of broods with living juveniles, first appearance of living juveniles, body length and dry weight of the parental daphnids. Production of offspring in the treated groups indicated that 1,3-BDDMA had an effect on the reproduction at concentrations greater than 6.26 mg/L. The most sensitive end point was the reduction of the reproductive output.     

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 day EC10 of 1,3-BDDMA in freshwater invertebrates based on reproduction

was 9.87 mg/L. The 21 day NOEC based on reproduction was 6.26 mg/L (OECD guideline 211, semi-static conditions).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC10

Remarks:

based on reproduction

Effect concentration:

9.87 mg/L

Additional information

The effects on reproduction were evaluated based on the reproductionper female parent animal inserted at the start of the exposure. The Step-down Cochran-Armitage test revealed a significant trend in mortality. Thus, according to OECD 211 it is required to report the effect values for the cumulative offspring per survived parent provided these values are lower than in the cumulative offspring per introduced parent.

The 21 day LC50 based on mortality was 48.6mg/L. The 21 day EC50 based on reproductive effects was 17.1 mg/L. The 21 day EC10 based on reproduction was 9.87 mg/L (95 % CI. 9.5 – 10.2 mg/L). The 21-day NOEC based on reproduction was 6.26 mg/L. The most sensitive end point was the reduction of the reproductive output.