2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

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:

not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to test guidelines and in accordance with GLP; however, there was no analytical confirmation of the test substance solutions reported in this study.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

No clean water control, only a solvent (acetone) control included in the test design

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
no data

Analytical monitoring:

no

Details on sampling:

No analytical sampling conducted.

Vehicle:

yes

Details on test solutions:

Fresh test solutions were prepared daily by adding small quantities of stock solutions of Epikote 828 in acetone to 500 ml of water in clean beakers.

The total amount of acetone added to each beaker, including controls, was adjusted to 0.05 ml (0.1 ml/L).

Fresh stock solutions were prepared every 7 days.

The test solutions also contained quantities of algal cells (Chlorella vulgaris; 0.1 to 0.5 x 10^6 cells/ml), yeast (5 mg/L) and soil extract (20 ml/L), as food.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: D. magna
- Strain/clone: The culture was derived froma clone held at ICI Brixham Laboratory, supplied originally to ICI by IRChA, France.
- The D. magna used in the test were less than 24 hours old.

The D. magna are held in 0.5 to 4 liters of water in suitably sized glass vessels, at densities of up to 20 animals per liter. They are kept in a temperature controlled room (20 plus or minus 2 degrees C) under artificial cool white light regulated to give a light/dark cycle of 16h/8h. The cultures are changed to fresh water at least once per week. This is a reconstituted hard water (pH 7.0 - 8.5; hardness 160 to 220 mg/L as CaCO3), identical to that used for the toxicity tests. The cultures are fed daily with Chlorella vulgaris and active dried yeast. Typical feeding rates are 10^6 cells/mL of Chlorella and 5 mg/L of yeast. The cultures are sieved regularly to remove young. Adults are first removed temprarily by pipette and the culture vessel contents passed through a sieve (5.6 mm mesh) on which the young animals are retained. The water is returned, with the adult D. magna to the culture vessel.

Young for use in toxicity tests are less than 24 hours old and are colleted from cultures ages between 15 and 35 days. 24 h before a test is set up the culture is sieved and the young discarded. The culture is then re-sieved 23 h later. D. magna retained on the sieve are then left in clean water for 1 h (they are now up to 24 hours old) and those swiming actively are used for testing. Young for testing are not taken from cultures which contain ephippia; these cultures are discarded.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Post exposure observation period:

no data

Hardness:

160 - 180 mg/L CaCO3

Test temperature:

18-22 degrees C

pH:

7.6 - 8.5

Dissolved oxygen:

7.1 - 9.1 mg/L

Salinity:

not applicable

Nominal and measured concentrations:

Nominal concentrations: 0, 0.03, 0.1, 0.3, 1, 3

Details on test conditions:

21-day static test with daily renewal of the test solutions.
TEST SYSTEM
- Test vessel: 600 ml glass beakers
- Fill volume: 500 ml
- Renewal rate of test solution (frequency/flow rate): daily renewals of test solutions
- No. of organisms per vessel: 10 organisms/ vessel
- No. of vessels per concentration (replicates): 4 replicate beakers per treatment
- No. of vessels per control (replicates): 4 solvent control beakers


OTHER TEST CONDITIONS
- Test was carried out in a temperature-controlled laboratory at a nominal temperature of 20 plus or minus 2 degrees C.
- Photoperiod: 16h light/ 6 h dark
- Light intensity: white fluorescent lighting was used


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Every 24 hours


VEHICLE CONTROL PERFORMED: yes, but no clean water control


RANGE-FINDING STUDY
- Test concentrations: 0.1 - 10 mg/L
- Results used to determine the conditions for the definitive study: 48 hour EC50 = 1.7 mg/L

Reference substance (positive control):

not specified

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: survival, growth and reproduction

Remarks on result:

other: no data

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: survival, growth and reproduction

Remarks on result:

other: no data

Details on results:

All the D. magna exposed to 3 mg/L of the test material died within 48 hours. Significant mortalities also occurred at 1 mg/L, accounting for 35% of the original animals by the end of the test. Mortalities in the other treatments, however, were no more than 5% and not statistically significant. Growth was also significantly reduced at 1 mg/L, the adults still alive at the end of the test being on average 7% smaller than in the controls. Reproductive output was significantly reduced at 1 mg/L. Although the onset of reproduction was no later than in the controls, the average number of young produced per adult over the test as a whole was some 20% less.

No effects were observed at a concentration of 0.3 mg/L but survival, growth and reproduction were all significantly reduced at 1 mg/L.

Results with reference substance (positive control):

no data

Reported statistics and error estimates:

no data

In the chronic toxicity test, survival, growth and reproduction rate were all significantly reduced at 1 mg/L of EPIKOTE 828, but were all unaffected at 0.3 mg/L. The threshold concentration for chronic toxic effect thus appears to lie somewhere between 0.3 and 1 mg/L, and therefore to be no more than about 5 times below the 48 h EC50 value. On this basis it is concluded that EPIKOTE 828 has a relatively low potential for chronic harm to D. magna beyond its acute toxicity.

Validity criteria fulfilled:

yes

Remarks:

One control beaker was omitted from the anaysis as it showed lower than normal reproduction.

Conclusions:

The NOEC is 0.3 mg/L but survival, growth and reproduction were all significantly reduced at 1 mg/L.

Executive summary:

D. magna were exposed to five concentrations of Epikote 828 ranging from 0.03 - 3 mg/L and control dilution water for 21 days in a static renewal test design. Survival, growth, and reproduction rate were all significantly reduced at 1 mg/L of Epikote 828, but were all unaffected at 0.3 mg/L.

Description of key information

The 21-day NOEC of 0.3 mg/L for BADGE and BADGE-related resins is based on surivival, growth and reproduction of Daphnia magna in a chronic toxicity test with BADGE.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.3 mg/L

Additional information

One long term test with Daphnia magna was conducted with BADGE. This test was deemed reliable and useful for risk assessment (Klimish score = 2). In this test, D. magna were exposed to five concentrations of Epikote 828 ranging from 0.03 - 3 mg/L and control dilution water for 21 days in a static renewal test design. Survival, growth, and reproduction rate were all significantly reduced at 1 mg/L of Epikote 828, but were all unaffected at 0.3 mg/L.