4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with m-phenylenebis(methylamine)

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

Study period:

18 October - 22 October 2012

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 MXDA (#42) 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:

A preliminary non-GLP trial indicated that a dosing (loading rate) of 100 mg BADGE-MXDA (#42)/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.
Bulk test solutions were prepared at nominal (target) loading rates of 0 (water control), 6.25, 12.5, 25, 50, and 100 mg BADGE-MXDA (#42)/L. Each test solution was created individually by weighing 0.125, 0.25, 0.50, 1.00, and 2.00 g of BADGE-MXDA (#42) onto separate glass cover slips, which were then added to 20 L of LDW to create the 6.25, 12.5, 25, 50, and 100 mg BADGE-MXDA (#42)/L loading rates, respectively. Test solutions were allowed to stir for approximately 24 hours.
All test solutions were allowed to settle for approximately 30 minutes and then a portion of the soluble fraction (solution minus undissolved test material) siphoned into the test vessels creating a 15 L (WAF) test solution. The control water along with all BADGE-MXDA (#42) test solutions appeared clear and colorless. Prior to use in the study, the 6.25, 12.5, 25, 50, and 100 mg/L loading rates were pH adjusted with 0.6, 1.0, 2.0, 3.5 and 6.5 ml of 1N HCL, respectively. Following these adjustments, all pH measurements ranged from 7.3 – 7.6 at test initiation.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The mortality did not exceed 5% (0% actual) of the population in the 48-hour period prior to test initiation. The mean fish wet (blotted dry) weight was 1.314 g (range: 0.783 to 1.639 g) and the mean total fish length was 5.0 cm (range: 4.2 to 5.6 cm). The length of the largest fish was no more than twice that of the shortest fish. The biological loading rate, based on the test solution volume at any one time (instantaneous loading rate) and calculated as [(mean fish weight of 1.314 g  7 fish per vessel)/15 L of solution per vessel], was 0.613 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:

50 mg CaCO3/L

Test temperature:

13 – 14°C

pH:

6.9 – 7.6

Dissolved oxygen:

7.4 – 10.1 mg/L (72 – 98% saturation)

Nominal and measured concentrations:

Nominal conentrations: 0 ( water control), 6.25, 12.5, 25, 50, and 100 mg Badge-MXDA (#42)/L

Details on test conditions:

Dissolved oxygen levels ranged from 7.4-10.1 mg/L (72-98% oxygen saturation), pH ranged from 6.9-7.6, and temperatures ranged from 13-14°C. Light intensity ranged from 766-860 lux. Water hardness was 50 mg CaCO3/L, alkalinity ranged from 24 to 28 mg CaCO3/L, and conductivity ranged from 166 to 217 µmhos/cm.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL 52.9-77.5

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

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-MXDA (#42)/L. Following 72-hours, one mortality was observed in the 25 mg/L loading rate. Observations following 96-hours of exposure revealed two fish exhibiting complete loss of equilibrium in the 50 mg/L loading rate, and one fish with a partial loss of equilibrium in the 25 mg/L loading rate. No fish mortality or sublethal effects were observed in the lowest two (nominal) loading rates or in the laboratory water control vessel during the conduct of this study.

Reported statistics and error estimates:

The acute toxicity values for rainbow trout (Oncorhynchus mykiss) exposed to Badge-MXDA (#42), over a 96-hour static exposure period and based on nominal loading rates, were as follows: The 24-hour LL50 value was 70.7 mg/L; the 95% confidence interval could not be calculated. The 48-hour LL50 value was 70.7 mg/L; the 95% confidence interval could not be calculated. The 72-hour LL50 value was 64.0 mg/L, with a 95% confidence interval of 52.9-77.5 mg/L. The 96-hour LL50 value was 64.0 mg/L, with a 95% confidence interval of 52.9-77.5 mg/L. 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-MXDA (#42) based on nominal loading rates, were as follows: LL50 = 64.0 mg/L (95% Confidence interval = 52.9 – 77.5 mg/L), NOELR = 50.0 mg/L

Executive summary:

The purpose of this study was to evaluate the acute toxicity of BADGE-MXDA (#42) 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-MXDA (#42)/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-MXDA (#42) 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) •96-hour NOELR = 50 mg/L

Description of key information

One fish acute toxicity study 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

64 mg/L

Additional information

The purpose of this study was to evaluate the acute toxicity of BADGE-MXDA (#42) 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-MXDA (#42)/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-MXDA (#42) 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); 96-hour NOELR = 50 mg/L.