Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
on-GLP study similar to OECD guideline 203. No analytical confirmation of test substance.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No analytical confirmation of test substance. fish were held at 12°C, which is outside of the recommended range of 21-25°C for this test species; significant loss of test material noted following 1 hour of aeration
GLP compliance:
no
Analytical monitoring:
not specified
Vehicle:
yes
Details on test solutions:
The compound was dissolved in acetone to increase its solubility. Acetone concentration in the aquaria did not exceed 0.5 mL/L. Various concentrations of the test material were tested.
Test organisms (species):
Pimephales promelas
Details on test organisms:
No data
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
No data
Test temperature:
No data
pH:
No data
Dissolved oxygen:
No data
Salinity:
No data
Nominal and measured concentrations:
Various concentrations
Details on test conditions:
Standard Laboratory Procedure- Eight liters of dechlorinated raw Lake Huron water were placed in each aquarium; one aquarium for each exposure concentration and one for a control. Stock solutions of the test material were prepared in distilled water after dissolving in acetone. The concentration of the stock solution was high enough so that no more than 5 mL of solvent is added to any aquarium. If a solvent stock was used, a second control should be added containing the largest amount of solvent added to any exposure. The desired amount of stock solution was added to the test aquarium and mixed by the addition of two liters (minus the stock solution volume) at the same time as toxicant introduction. Ten fish were then added and the aquaria placed in the constant temperature trough. The aquaria may be placed in the trough first, then water, toxicant, and fish added. Fish exposed at 17°C or lower did not exceed a loading of 0.8 g/L, and fish exposed at temperatures higher than 17°C did not exceed 0.5 g/L. The troughs were filled with water. Observations were made daily for 96 hours or a longer period noting the condition of the fish in the aquaria.

Typical analysis of Lake Huron water
pH: 8.0
Total alkalinity, as CaCO3: 83 mg/L
Total hardness, as CaCO3: 102 mg/L
Chloride, as Cl: 9.4 mg/L
Sulfate, as SO4: 14 mg/L
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC10
Effect conc.:
6.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 4.4-7.2 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
7.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 6.5-8.1 mg/L
Duration:
96 h
Dose descriptor:
other: LC90
Effect conc.:
8.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 8.1-10.8 mg/L
Duration:
96 h
Dose descriptor:
other: NOAEL
Effect conc.:
3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
No Adverse Effect Level: 3.2 mg/L
Toxic Effects: 5.6 mg/L
Partial Kill: 7.5 mg/L
100% Kill: 10.0 mg/L
Reported statistics and error estimates:
Calculation of LC Values- Fish toxicity results were reported as 96-hr LC10, LC50, and LC90 values, i.e., those concentrations which kill 10, 50, and 90%, respectively, of the test organisms in a specified length of time. These values as well as their 95% confidence intervals and the slope of the regression curve were calculated using a computer program of Finney's method for probit analysis.
Conclusions:
DVB-55 showed 96-hr LC10, LC50, and LC90 values of 6.6 (4.4-7.2), 7.5 (6.5-8.1) , and 8.6 (8.1-10.8) mg/L, respectively, to fathead minnows (Pimephales promelas Rafinesque) in static water tests.
Executive summary:

Screening tests were run on a sample of divinylbenzene-55 (DVB-55) and the following conclusions may be made:

 

Movement - Water solubility is 44 mg/L and the vapour pressure is 1.0 mm Hg at 33°C. Removal after 1 hour aeration was 96% by sensitive dichromate analysis and 100% after 4 hours.

 

Stability - DBV-55 does not consume oxygen in the standard 20-day BOD test and will probably not degrade in a biological wastewater treatment plant.

 

Bioconcentration - DVB-55 has a predicted bioconcentration factor (BCF) of 184 which may be contrasted with PCB which has a BCF of 10000 or more. The persistence of DVB-55 in the aquatic environment is unknown.

 

Fish toxicity - DVB-55 showed 96-hr LC10, LC50, and LC90 values of 6.6 (4.4-7.2)*, 7.5 (6.5-8.1) , and 8.6 (8.1-10.8) mg/L, respectively, to fathead minnows, Pimephales promelas Raf inesque, in static water tests.

 

*95% Confidence Interval

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
not specified
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
The tested concentrations were measured at 0 hour, 7 days and 14 days.


Vehicle:
yes
Details on test solutions:
Vehicle/Solvent and Concentrations: Dimethylamide and HCO-40 were used as solvents in the tests.
Stock Solutions Preparations and Stability: The test substance (2.25 g), Dimethylamide (4.50 g) and HCO-40 (13.5 g) were dissolved in dilution water, and the amount of the test original solution was adjusted to 1000 mL by dilution water (test substance 2250 mg/L). Dimethylamide (13.5 g) and HCO-40 (40.50 g) were dissolved in dilution water, and the amount of the solvent original solution was adjusted to 3000 mL by dilution water. The test original solution was diluted by the solvent original solution to prepare four stock solutions (test substances; 225, 485, 1050 and 2250 mg/L).
Test organisms (species):
Oryzias latipes
Details on test organisms:
Test Organisms:
a) Size (length and weight): 1.95 cm (1.70 - 2.14 cm) in length; 0.144 g (0.092 - 0.208 g) in weight
b) Age: Not described
c) Any pretreatment: Acclimated for several days before testing, any groups showing > 5 % mortality were not used for testing. Not fed for 24 hours before the test started.
d) Supplier/Source: SANKYO SUISAN Co., Ltd. (TOKYO, JAPAN)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
14 d
Post exposure observation period:
None
Hardness:
Dilution water- 63 mg/L (CaCO3)

Test temperature:
23.6 - 25.7°C

pH:
7.4-7.7

Dissolved oxygen:
7.5-8.4 mg/L

Salinity:
No data
Nominal and measured concentrations:
Nominal Concentrations (as mg/L): 0, 0.499, 1.08, 2.33 and 4.99
Measured Concentrations (as mg/L): 0.456, 0.871, 1.97 and 4.65


Details on test conditions:
Test Conditions:
a) Dilution Water Source: Dechlorinated tap water
b) Dilution Water Chemistry: Hardness (as CaCO3) 63 mg/L, pH 7.8 (22°C), Alkalinity 44 mg/L, Chlorine concentration < 0.01 mg/L
c) Exposure Vessel Type: 5 L Glass Beaker covered with Teflon Sheet
d) Nominal Concentrations (as mg/L): 0, 0.499, 1.08, 2.33 and 4.99
e) Vehicle/Solvent and Concentrations: Dimethylamide and HCO-40 were used as solvents in the teats.
f) Stock Solutions Preparations and Stability: The test substance (2.25 g), Dimethylamide (4.50 g) and HCO-40 (13.5 g) were dissolved in dilution water, and the amount of the test original solution was adjusted to 1000 mL by dilution water (test substance 2250 mg/L). Dimethylamide (13.5 g) and HCO-40 (40.50 g) were dissolved in dilution water, and the amount of the solvent original solution was adjusted to 3000 mL by dilution water. The test original solution was diluted by the solvent original solution to prepare four stock solutions (test substances; 225, 485, 1050 and 2250 mg/L).
g) Number of Replicates: 1
h) Fish per Replicates: 10
i) Flow-through Rate: 22.55 mL/min.(stock solution: 0.05 mL/min, dilution water: 22.5 mL/min)
j) Water Temperature: 23.6 - 25.7°C
Reference substance (positive control):
not specified
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
1.78 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
0.456 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Cumulative Mortality:
7 days; Control (0), 0.499 mg/L (0), 1.08 mg/L (0), 2.33 mg/L (4) and 4.99 mg/L (8) 14 days; Control (0), 0.499 mg/L (0), 1.08 mg/L (0), 2.33 mg/L (6) and 4.99 mg/L (10)
- Calculation of LC50: Based on the measured concentrations, because some data of the measured concentrations were <80% of the nominal concentrations
Reported statistics and error estimates:
Data Analysis: Binominal method for LC50
Method of Calculating Mean Measured Concentrations: Arithmetic mean
Validity criteria fulfilled:
yes
Conclusions:
The LC50 is 1.78 mg/L and the NOEC is 0.456 mg/L based on the measured concentrations (arithmatic mean).
Executive summary:

This study was conducted in accordance with OECD Guideline 204. The LC50 and NOEC in Oryzias latipes is 1.78 mg/L and 0.456 mg/L, respectively, based on the measured concentrations (arithmatic mean).

Description of key information

Several GLP and non-GLP studies according to or similar to OECD guidelines 203 are available for the reaction mass of divinylbenzene and ethylstyrene. In addition, one GLP study according to OECD guideline 204 is available. The 14-day LC50 for DVB-HP grade (reaction mass of 80% divinylbenzene and 20% ethylstyrene) was 1.78 mg/L in medaka.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1.78 mg/L

Additional information

A total of six acute toxicity studies with fish exist for the reaction mass of divinylbenzene and ethylstyrene. Two acute fish toxicity studies (non-GLP, similar to OECD guideline 203) were performed with DVB-55 (reaction mass of approximately 55% divinylbenzene and 45% ethylstyrene). The other four acute toxicity test were performed with DVB-HP (reaction mass of approximately 80% divinylbenzene and 20% ethylstyrene). The two key studies for DVB-HP were conducted under GLP and according to OECD guidelines 203 and 204.

 

The DVB-HP grade proved to be more toxic to fish (and also invertebrates) in comparison to DVB-55. The 96-hour LC50 for DVB-55 was 7.5 mg/L in fathead minnows, while the 96-hour LC50 for DVB-HP ranged from 3.45 - 4.16 mg/L in medaka fish. In a high-quality study with medaka fish, the 14-day NOEC and LC50 for DVB-HP was determined to be 0.456 and 1.78 mg/L, respectively. The 14-day LC50 of 1.78 mg/L was the lowest acute endpoint, and this value was selected as the key parameter for short-term toxicity to fish.

 

No acute toxicity study in fish is available for DVB-63 (reaction mass of approximately 63% divinylbenzene and 37% ethylstyrene). However, as higher concentrations of each of the components are present in the grades tested (DVB-55 and DVB-HP), the toxicity of both components of this reaction mass has been sufficiently investigated by the studies conducted on those grades.