Reaction mass of (2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate and 2-Propenoic acid, 1,1'-[[dihydro-5-(2-hydroxyethyl)-2,4,6-trioxo-1,3,5-triazine-1,3(2H,4H)-diyl]di-2,1-ethanediyl] ester

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 11 - June 16, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

Adopted: Jul. 17, 1992

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

MIRAMER S512, Lot No. 170604470, Manufacturing date Jun. 04, 2017, Expiration date Jun. 07, 2018; Purity >95.0 %

Analytical monitoring:

yes

Details on sampling:

At initial exposure (0 hour) and at the end of test (96 hours), this study was conducted the analysis of control and treatment groups with triple sampling.

Vehicle:

yes

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Producer of fish: Gangnam Aquarium; Receipt date Jul. 27, 2017; Supply date May 14, 2018 (Preliminary test); May 21, 2018 (Main test); Body length of the test fish: within 1 ~ 3 cm (measured from head to tail fin)

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Hardness:

92 mg CaCO3/L

Test temperature:

22.2oC (21.7-22.6)

pH:

7.88 (7.21-8.07)

Dissolved oxygen:

80.2% (71.0-93.4)

Nominal and measured concentrations:

Nominal

Reference substance (positive control):

yes

Remarks:

Pentachlorophenol sodium salt

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

22.64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Confidence interval: 20.28-25.29 mg/L

Results with reference substance (positive control):

LC50 (96hr): 0.397 mg/L (0.35-0.45 mg/L, 95% confidenceinterval)

Reported statistics and error estimates:

LC50 (96hr): 0.397 mg/L (0.35-0.45 mg/L, 95% confidenceinterval)

Validity criteria fulfilled:

yes

Conclusions:

This study was to evaluate acute toxicity with MIRAMER S512 on fish (Zebra-fish,Brachydanio rerio) for 96 hours according to OECD 203. Exposure method of the test substance was carried out static test for 96 hours according to the result of stability test based on active ingredient. Effect concentration was determined based on nominal concentration. Main test according to the result of preliminary test was performed, control, 10, 18, 32, 56 and 100 mg/L (nominal concentration). During the main test, the test solutions 10, 18, 32, 56 and 100 mg/L were analyzed and the geometric mean concentration measured for exposure period were 12.176, 21.553, 36.992, 55.103 and 92.328 mg/L (measured concentrations). The LC50 and 95% confidence limit for mortality was statistically analyzed at 24, 48, 72 and 96 hours after exposure using the Probit and TSK (Trimmed Spearman-Karber) (EPA600/4-85/13, 1985). NOEC was determined the highest concentration causing no abnormal behavior and number of lethal. 24, 48, 72 and 96 hours-LC50 of MIRAMER S512 according to the result of test conditions and test result were 31.87, 23.999, 22.64 and 22.64 mg/L, respectively. NOEC of 24, 48, 72 and 96 hours were 18, 10, 10 and 10 mg/L (nominal concentration).

Executive summary:

This study was to evaluate acute toxicity with MIRAMER S512 on fish (Zebra-fish,Brachydanio rerio) for 96 hours according to OECD 203. Exposure method of the test substance was carried out static test for 96 hours according to the result of stability test based on active ingredient. Effect concentration was determined based on nominal concentration. Main test according to the result of preliminary test was performed, control, 10, 18, 32, 56 and 100 mg/L (nominal concentration). During the main test, the test solutions 10, 18, 32, 56 and 100 mg/L were analyzed and the geometric mean concentration measured for exposure period were 12.176, 21.553, 36.992, 55.103 and 92.328 mg/L (measured concentrations). The LC50 and 95% confidence limit for mortality was statistically analyzed at 24, 48, 72 and 96 hours after exposure using the Probit and TSK (Trimmed Spearman-Karber) (EPA600/4-85/13, 1985). NOEC was determined the highest concentration causing no abnormal behavior and number of lethal. 24, 48, 72 and 96 hours-LC50 of MIRAMER S512 according to the result of test conditions and test result were 31.87, 23.999, 22.64 and 22.64 mg/L, respectively. NOEC of 24, 48, 72 and 96 hours were 18, 10, 10 and 10 mg/L (nominal concentration).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across from short-term toxicity study on one closely structural and physicochemical related substance (TMPTA)

Justification for type of information:

The hypothesis for a read-across approach to data from TMPTA is the similarity of the chemical structures.Both the target substance (T) and TMPTA and Tris(2-hydroxyethyl) isocyanurate are triacrylates. The main difference is the core group to which the acrylates are attached. Both core groups are shown to be non-toxic and will not contribute to the observed toxicity.
For further read-across see document attached in section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Total exposure duration:

96 h

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.87 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Conclusions:

Trimethylolpropantriacrylat (TMPTA) (S2) was tested for acute fish toxicity in Leuciscus idus according to DIN 38412/15. After 96 h exposure to nominal concentrations of 0.1, 0.215, 0.464, 1 and 2.15 mg/l an LC50 was determined to be 1.47 mg/l as the geometric mean of the highest concentration with no mortality, i.e. 1 mg/l, and the concentration with 100% mortality, i.e. 2.15 mg/l.. The NOEC was 1 mg/l. Another study with TMPTA (S2) according to OECD Guideline 203 (fish acute toxicity test), resulted in 96h-NOEC = 0.89 mg/L; 96h-LOEC = 1.71 mg/L; 96h-LC10 = 0.75 mg/L; 96h-LC50 = 0.87 mg/L

The hypothesis for a read-across approach to data from TMPTA is the similarity of the chemical structures. Both the target substance (T) and the source substance (TMPTA, S2) are triacrylates. The main difference is the core group to which the acrylates are attached. Both core groups are shown to be non-toxic and will not contribute to the observed toxicity.
For further read-across see document attached in section 13.

Executive summary:

Trimethylolpropantriacrylat (TMPTA) (S2) was tested for acute fish toxicity in Leuciscus idus according to DIN 38412/15. After 96 h exposure to nominal concentrations of 0.1, 0.215, 0.464, 1 and 2.15 mg/l an LC50 was determined to be 1.47 mg/l as the geometric mean of the highest concentration with no mortality, i.e. 1 mg/l, and the concentration with 100% mortality, i.e. 2.15 mg/l.. The NOEC was 1 mg/l. Another study with TMPTA (S2) according to OECD Guideline 203 (fish acute toxicity test), resulted in 96h-NOEC = 0.89 mg/L; 96h-LOEC = 1.71 mg/L; 96h-LC10 = 0.75 mg/L; 96h-LC50 = 0.87 mg/L

The hypothesis for a read-across approach to data from TMPTA is the similarity of the chemical structures. Both the target substance (T) and the source substance (TMPTA, S2) are triacrylates. The main difference is the core group to which the acrylates are attached. Both core groups are shown to be non-toxic and will not contribute to the observed toxicity.

For further read-across see document attached in section 13.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1988-02-29 - 1988-03-4

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study

Remarks:

LC50 not in agreement with range findings

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

DIN 38412/15

Deviations:

no

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

yes

Test organisms (species):

Leuciscus idus

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.47 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

				mortality
nominal conc. [mg/l]	Number of fish	1h	4h	24h	48h	72h	96h
0.100	10	0	0	0	0	0	0
0.215	10	0	0	0	0	0	0
0.464	10	0	0	0	0	0	0
1.000	10	0	0	0	0	0	0
2.150	10	0	0	10	10	10	10
0.000	10	0	0	0	0	0	0
solvent control	10	0	0	0	0	0	0

NOEC: 1 mg/l

max concentratiuon causing no mortality: 1 mg/l

minimum concentration causing 100% mortality: 2.15 mg/l

Validity criteria fulfilled:

yes

Conclusions:

The LC 50 in Leuciscus idus of the test substance was determined to be 1.47 mg/l.

Executive summary:

Trimethylolpropantriacrylat was tested for acute fish toxicity in Leuciscus idus according to DIN 38412/15. After 96 h exposure to nominal concentrations of 0.1, 0.215, 0.464, 1 and 2.15 mg/l an LC 50 was determined to be 1.47 mg/l as the geometric mean of the highest concentration with no mortality, i.e. 1 mg/l, and the concentration with 100% mortality, i.e. 2.15 mg/l.. The NOEC was 1 mg/l.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study initiation date: 09 December 2016 Experimental start date: 19 December 2016 Experimental completion date: 07 April 2017 Study completion date: -

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Test temperatures recorded during the test were outside the 21-25°C range controlled at ± 2°C, as recommended in the test guideline. This deviation was considered not to have affected the outcome of the study objectives.

GLP compliance:

yes

Specific details on test material used for the study:

Chemical name: Trimethylolpropane triacrylate
CAS number: 15625-89-5
Batch number: F0994478VS
Purity: 80.2% (TMPTA content)
Date of reception in the test facility: 10 October 2016
Expiration date: 31 August 2017
Internal identification: 0050-16
Appearance: colourless liquid
Water solubility: 500 mg/L (according to the SDS)
Relative density: 1,1086 at 20°C (according to the SDS)
Storage conditions: well-ventilated place, ambient temperature and obscurity

Analytical monitoring:

yes

Remarks:

HPLC/MS

Details on test solutions:

All testing was performed using a synthetic medium. Chemical reagents used for the preparation of this dilution water were of “analytical grade”; it is prepared according to the protocol described in standard NF EN ISO 6341:

The following stock solutions were prepared:

- CaCl2, 2H2O: 11.76 g per litre of water,
- MgSO4, 7H2O: 4.93 g per litre of water,
- NaHCO3: 2.59 g per litre of water,
- KCl: 0.23 g of per litre of water,

Dilution water was obtained by adding a concentration of 25 mL/L of each of the stock solutions and then aerating the solution until oxygen saturation.

The sum of Ca and Mg ions in dilution water was of 2.5 mmol/L and ratios of Ca/Mg et Na/K were 4 and 10, respectively.

Test solution
(mg/L)
Control
0.21
0.47
1.03
2.27
5.00

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test organisms were Danio rerio (Teleostei, Cyprinidae), obtained on the 28 July 2016 from a recognised supplier: La Grande Rivière France (69490 Saint-Forgeux). All fish were in good health and free from any apparent malformation. Mortality of the batch was less than 5% in the week preceding the start of the study. No disease treatments were administered throughout holding and testing.

Holding was maintained within the laboratory at a temperature of 21-25oC in glass tanks. A light cycle of 12 h light and 12 h dark was applied, illumination being provided by fluorescent tubes (intensity between 400 and 800 lux at the surface of the tanks). Tanks were aerated to ensure that the dissolved oxygen concentration is at least 60% of air saturation value in holding tanks and in test tanks. During holding, fish were fed twice per day with ground flake food TetraMin®.

The fish were not fed for a period of 24h prior to test commencement or throughout the duration of the test.

Fish were added to the test tanks within 30 min after the completion of preparation of the test solutions. All test fish were weighed prior to the test and a representative number of test fish batch (10 at random) was measured after the test to assess compliance with guideline criteria.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

The total hardness was determined at 250 mg CaCO3/L

Test temperature:

The temperature during the definitive test remained constant within ± 2°C during the test but was not maintained in a range from 21°C to 25°C: mean measured temperature: 21.1°C, min.: 20.0°C, max.: 21.8°C.
During the preliminary range-finding test the temperature was maintained in a range from 21°C to 25°C and remaining constant within ± 2°C during the test: mean measured temperature: 22.6°C, min.: 22.2°C, max.: 23.3°C.

pH:

pH of fresh solution varied between 8.0-8.1. The pH of the old solution varied betwen 7.5-7.7.

Dissolved oxygen:

The dissolved oxygen of the fresh solutions varied between 99.2-100% saturation, and of the old solution varied between 82-92% saturation.

Salinity:

Not measured

Conductivity:

Not measured

Nominal and measured concentrations:

For the definitive test, aliquots were removed from each prepared concentration every day from fresh and old solutions. Chemical analysis of test samples taken on fresh and old solutions indicated that measured concentrations of the test item did not remain within 80-120% of the nominal concentrations and were not maintained over a 24h test period (i.e. deviation >20%). As a consequence, the stability of the substance was not confirmed over the test period, the exposure concentrations were thus based on the geometric mean of measured concentrations.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.87 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.89 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

1.71 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC10

Effect conc.:

0.75 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

The sensitivity of the test system and the methodology are evaluated with every batch of fish by performing an acute toxicity test on potassium dichromate. The values of 24h-LC50 obtained with the batch used for the definitive test were as follows: 24h-LC50 = 173.6 mg/L (obtained on 11 August 2016).

Validity criteria fulfilled:

yes

Remarks:

i)The mortality in the control did not exceed 10% at the end of the test; ii)The dissolved oxygen in the test tanks remained above 60% of the air saturation value at the end of the test; iii)The pH did not vary by more than 1 unit.

Conclusions:

Acute toxicity test with Danio rerio resulted in an
96h-NOEC       0.89 mg/L
96h-LOEC       1.71 mg/L
96h-LC10       0.75 mg/L
96h-LC50       0.87 mg/L

Executive summary:

The acute toxicity of the test substance to Danio rerio exposed under semi-static conditions for 96h was assessed according to the OECD 203 Guideline. Fish were exposed to a series of test solutions renewed every day throughout the test period

Test item concentrations were determined at each observation time on fresh and old solutions: as chemical analysis of test samples taken on fresh and old solutions indicated that measured concentrations of the test item did not remain within 80-120% of the nominal concentrations and were not maintained over a 24h test period (i.e. deviation >20%), the exposure concentrations were based on the geometric mean of measured concentrations and determined as follows:

96h-NOEC       0.89 mg/L

96h-LOEC       1.71 mg/L

96h-LC10       0.75 mg/L

96h-LC50       0.87 mg/L

Description of key information

The acute toxicity with MIRAMER S512 on fish (Zebra-fish,Brachydanio rerio) for 96 hours was tested according to OECD 203. Exposure method of the test substance was carried out static test for 96 hours according to the result of stability test based on active ingredient. Effect concentration was determined based on nominal concentration. During the main test, the test solutions 10, 18, 32, 56 and 100 mg/L were analyzed and the geometric mean concentration measured for exposure period were 12.176, 21.553, 36.992, 55.103 and 92.328 mg/L (measured concentrations). The LC50and 95% confidence limit for mortality was statistically analyzed at 24, 48, 72 and 96 hours after exposure using the Probit and TSK (Trimmed Spearman-Karber) (EPA600/4-85/13, 1985). NOEC was determined the highest concentration causing no abnormal behavior and number of lethal. 24, 48, 72 and 96 hours-LC50 of MIRAMER S512 according to the result of test conditions and test result were 31.87, 23.999, 22.64 and 22.64 mg/L, respectively. NOEC of 24, 48, 72 and 96 hours were 18, 10, 10 and 10 mg/L (nominal concentration).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

22.64 mg/L

Additional information

(Key study):

The acute toxicity with MIRAMER S512 on fish (Zebra-fish,Brachydanio rerio) for 96 hours was tested according to OECD 203. Exposure method of the test substance was carried out static test for 96 hours according to the result of stability test based on active ingredient. Effect concentration was determined based on nominal concentration. During the main test, the test solutions 10, 18, 32, 56 and 100 mg/L were analyzed and the geometric mean concentration measured for exposure period were 12.176, 21.553, 36.992, 55.103 and 92.328 mg/L (measured concentrations). The LC50 and 95% confidence limit for mortality was statistically analyzed at 24, 48, 72 and 96 hours after exposure using the Probit and TSK (Trimmed Spearman-Karber) (EPA600/4-85/13, 1985). NOEC was determined the highest concentration causing no abnormal behavior and number of lethal. 24, 48, 72 and 96 hours-LC50 of MIRAMER S512 according to the result of test conditions and test result were 31.87, 23.999, 22.64 and 22.64 mg/L, respectively. NOEC of 24, 48, 72 and 96 hours were 18, 10, 10 and 10 mg/L (nominal concentration).