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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 to 28 September 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 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

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-IPD (#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. Each WAF preparation was made using a direct additon. Due to the low loading rates for the definitive study, 10 and 5 L of solution were made for the 0.43 and 0.94 mg/L loading rates, respecitvely; all other loading rates were made in 1–L volumes. Bulk test solutions were prepared using direct additions of 0.0043, 0.0047, 0.0021, 0.0045, and 0.0100 g into appropriate volumes of LDW to achieve loading rates of 0.43, 0.94, 2.1, 4.5, and 10 mg BADGE-MXDA (#42)/L. Aliquots were placed on glass cover slips and dropped directly into the appropriate volume of water in a glass vessel (glass battery jar for the 0.43 and 0.94 mg/L loading rates; 2-L glass beaker for all other loading rates). A stir bar was added and the solutions were coveredd and stirred for 24 hours prior to use. All solutions were clear and colorless.

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organism was the freshwater cladoceran, Daphnia magna, from in-house cultures. Daphnid neonates less than 24 hours old from a laboratory-reared culture were used as the test organisms. Neonates were only used from daphnids which have had at least three broods. The day before neonates were needed for testing (<24 hours prior to test initiation), neonates within the culture vessels were removed leaving only adult daphnids in the vessels; these neonates were not used in the study. On the following day, neonates produced overnight in these same culture vessels were again removed from the vessels and placed into a glass beaker containing LDW. These neonates (<24 hours old) were held in an incubator until they were used for the study.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None

Hardness:

58 – 64 mg CaCO3/L

Test temperature:

19 – 20°C

pH:

7.4 – 7.7

Dissolved oxygen:

8.4 – 8.9 mg/L (94 – 100% saturation)

Nominal and measured concentrations:

Nominal test concentrations: 0 (control), 0.43, 0.94, 2.1, 4.5, and 10 mg BADGE-MXDA (#42)/L

Details on test conditions:

Dissolved oxygen levels ranged from 8.4 – 8.9 mg/L (94 – 100% oxygen saturation), temperatures ranged from 19 – 20°C, and pH ranged from 7.4 – 7.7. Light intensity ranged from 740 – 939 lux. Alkalinity ranged from 38 – 40 mg CaCO3 at test initiation. Hardness ranged from 58 – 64 mg CaCO3 at test initiation. Conductivity ranged from 177 – 204 µmhos/cm at test initiation.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

1.46 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL 1.35-1.58 mg/L

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 0.94 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobility

Details on results:

RESULTS (Based on Nominal Loading Rates): 24 hour EL50 = 1.71 mg/L (95% confidence interval = 1.47 – 1.99 mg/L); 48 hour EL50 = 1.46 mg/L (95% confidence interval = 1.35 – 1.58 mg/L); 48 hour NOELR = 0.94 mg/L (Based on highest loading rate exhibiting no statistically significant immobility or sublethal effects.)

Reported statistics and error estimates:

The 24-hour EL50 value, calculated by the Trimmed Spearman-Karber Program, was 1.71 mg/L, with 95% confidence intervals of 1.47 – 1.99 mg/L; the Spearman Karber trim was 0%. The 48-hour EL50 value, calculated by the Trimmed Spearman-Karber Program, was 1.46 mg/L, with 95% confidence intervals of 1.35 – 1.58 mg/L; the Spearman Karber trim was 0%.
• The 48-hour NOELR was 0.94 mg/L, calculated by the Fisher’s Exact Test.

None                     

Validity criteria fulfilled:

yes

Conclusions:

The 24-hour EL50 = 1.71 mg/L (95% confidence intervals 1.47 – 1.99 mg/L). The 48-hour EL50 = 1.46 mg/L ( 95% confidence intervals 1.35 – 1.58 mg/L). The 48-hour NOELR => 0.94 mg/L.

Executive summary:

The purpose of this study was to evaluate the acute toxicity of BADGE-MXDA (#42) to the freshwater cladoceran, Daphnia magna, over a 48-hour exposure period. Based on the limited solubility of the test material, water accomodated fractions (WAFs) were used for exposures (OECD, 2000). The definitive test was conducted with four replicate vessels per test level, with five daphnids each, exposed to nominal loading rates of 0 (water control), 0.43, 0.94, 2.1, 4.5, and 10 mg BADGE-MXDA (#42)/L. The acute toxicity values for BADGE-MXDA (#42) with Daphnia magna were determined based on nominal loading rates. The results were as follows:

The 24-hour EL50 was 1.71 mg/L (95% confidence intervals 1.47 – 1.99 mg/L); the 48-hour EL50 was 1.46 mg/L ( 95% confidence intervals 1.35 – 1.58 mg/L). The 48-hour NOELR was => 0.94 mg/L.

Description of key information

One daphnia acute study 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1.46 mg/L

Additional information

The purpose of this study was to evaluate the acute toxicity of BADGE-MXDA (#42) to the freshwater cladoceran, Daphnia magna, over a 48-hour exposure period. Based on the limited solubility of the test material, water accommodated fractions (WAFs) were used for exposures (OECD, 2000). The definitive test was conducted with four replicate vessels per test level, with five daphnids each, exposed to nominal loading rates of 0 (water control), 0.43, 0.94, 2.1, 4.5, and 10 mg BADGE-MXDA (#42)/L. The acute toxicity values for BADGE-MXDA (#42) with Daphnia magna were determined based on nominal loading rates. The results were as follows: The 24-hour EL50 = 1.71 mg/L (95% confidence intervals 1.47 – 1.99 mg/L); The 48-hour EL50 = 1.46 mg/L ( 95% confidence intervals 1.35 – 1.58 mg/L); The 48-hour NOELR = 0.94 mg/L