4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminomethyl-3,5,5-trimethylcyclohexylamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This is a GLP Guideline study. All the validity criteria were met. Analytical test material characterization and quantification was included in the study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Because BADGE IPD (#33) is a multi-component substance of limited solubility, WAFs were created and analyzed via non-purgable organic carbon (NPOC) and all values reported are nominal. This method is outlined in the OECD guidance (No. 23) on Aquatic Testing of Difficult Substances and Mixtures. NPOC was measured in test solutions at test initiation and termination.

Vehicle:

no

Details on test solutions:

Bulk test solutions were prepared at nominal (target) loading rates of 0 (water control), 6.25, 12.5, 25, 50, and 100 mg BADGE-IPD (#33)/L. Each test solution was created individually by weighing 0.125, 0.25, 0.50, 1.00, and 2.00 g of BADGE-IPD (#33) onto separate glass cover slips, which were then added to 20 L of diluation water to create the 6.25, 12.5, 25, 50, and 100 mg BADGE-IPD (#33)/L loading rates, respectively. A preliminary non-GLP trial indicated that a dosing (loading rate) of 100 mg BADGE-IPD (#33)/L required 24 hours of stirring to reach an equilibrium in water-soluble components (i.e., a change of <20% measured dissolved organic carbon concentrations between two sampling points); therefore, the WAF preparations for all test solutions were stirred for approximately 24 hours prior to test initiation.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The mean fish wet (blotted dry) weight was 1.116 g (range: 0.903 to 1.364 g) and the mean total fish length was 4.9 cm (range: 4.3 to 5.2 cm). The length of the largest fish was no more than twice that of the shortest fish. The biologicl loading rate, based on the test solution volume at any one time (instantaneous loading rate) and calculated as [(mean fish weight of 1.116 g × 7 fish per vessel)/15 L of solution per vessel], was 0.521 g fish/L of test solution.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

54 mg CaCO3/L

Test temperature:

13 – 14°C

pH:

6.9 – 7.6

Dissolved oxygen:

7.3 mg/L – 10.2 mg/L (71 – 99% saturation)

Nominal and measured concentrations:

Nominal concentrations: 0 ( water control), 6.25, 12.5, 25.0, 50.0, and 100 mg BADGE-IPD (#33)/L

Details on test conditions:

Dissolved oxygen levels ranged from 7.3-10.2 mg/L (71-99% oxygen saturation), pH ranged from 6.9-7.6, and temperatures ranged from 13-14°C. Light intensity ranged from 808-910 lux. Water hardness ranged from 52-54 mg CaCO3/L, alkalinity was 28 mg CaCO3/L, and conductivity ranged from 164 to 209 μmhos/cm.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

70.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: CL not calculable

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

behaviour

Details on results:

The fish were observed for mortality and sublethal effects at approximately 24-, 48-, 72-, and 96-hours of exposure. After 24-hours, 100% mortality was recorded in the highest (nominal) loading rate of 100 mg BADGE-IPD (#33)/L. No fish mortality or sublethal effects were observed in any of the lower (nominal) loading rates or in the laboratory water control vessel during the conduct of this study.

Reported statistics and error estimates:

All LL50 values for rainbow trout (Oncorhynchus mykiss) exposed to BADGE IPD (#33), at 24, 48, 72 and 96 houurs were 70.7 mg/L and the 95% confidence interval could not be calculated. The 96-hour NOELR was 50 mg/L.

Sublethal observations / clinical signs:

None       

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour acute toxicity values for Oncorhynchus mykiss exposed to BADGE-IPD (#33) based on nominal loading rates, were as follows: LL50 = 70.7 mg/L (95% Confidence interval were not calculable), NOELR = 50.0 mg/L.

Executive summary:

The purpose of this study was to evaluate the acute toxicity of BADGE-IPD (#33) to the rainbow trout,Oncorhynchus mykiss. Based on the limited solubility of this multi-component test substance, water accommodated fractions (WAFs) were prepared and used for exposures (OECD, 2000) at the following loading rates: 6.25, 12.5, 25, 50, and 100 mg BADGE-IPD (#33)/L. The data collected were used to calculate the 24-, 48-, 72-, and 96-hour LL50 values (the loading rate estimated to result in 50% mortality of the test population after 24-, 48-, 72-, and 96 hours of exposure, respectively) and a 96-hour no-observed-effect-loading rate (NOELR). The acute toxicity values for Oncorhynchus mykiss exposed to BADGE-IPD (#33) over a 96-hour static exposure period and based on nominal loading rates, were as follows: 24-hour LL50 = 70.7 mg/L (95% Confidence interval = not available); 48-hour LL50 = 70.7 mg/L (95% Confidence interval = not available); 72-hour LL50 = 64.0 mg/L (95% Confidence interval = 52.9 – 77.5 mg/L); 96-hour LL50 = 64.0 mg/L (95% Confidence interval = 52.9 – 77.5 mg/L). The 96-hour NOELR was 50 mg/L.

Description of key information

Single acute toxicity study with freshwater fish

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

70.7 mg/L

Additional information

The purpose of this study was to evaluate the acute toxicity of BADGE-IPD (#33) to the rainbow trout, Oncorhynchus mykiss. Based on the limited solubility of this multi-component test substance, water accommodated fractions (WAFs) were prepared and used for exposures (OECD, 2000) at the following loading rates: 6.25, 12.5, 25, 50, and 100 mg BADGE-IPD (#33)/L. The data collected were used to calculate the 24-, 48-, 72-, and 96-hour LL50 values (the loading rate estimated to result in 50% mortality of the test population after 24-, 48-, 72-, and 96 hours of exposure, respectively) and a 96-hour no-observed-effect-loading rate (NOELR). The acute toxicity values for Oncorhynchus mykiss exposed to BADGE-IPD (#33) over a 96-hour static exposure period and based on nominal loading rates, were as follows: 24-hour LL50 = 70.7 mg/L (95% Confidence interval = not available); 48-hour LL50 = 70.7 mg/L (95% Confidence interval = not available); 72-hour LL50 = 64.0 mg/L (95% Confidence interval = 52.9 – 77.5 mg/L); 96-hour LL50 = 64.0 mg/L (95% Confidence interval = 52.9 – 77.5 mg/L). The 96-hour NOELR was 50 mg/L.