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 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:

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 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:

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):

Daphnia magna

Details on test organisms:

Neonates were only used from daphnids which have had at least 3 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 laboratory dilution water. These neonates (<24 hours old) were held in an incubator until 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:

52 – 56 mg CaCO3/L

Test temperature:

19 – 20 °C

pH:

7.4 – 7.8

Dissolved oxygen:

9.0 – 9.1 mg/L (101 - 102% saturation)

Nominal and measured concentrations:

Nominal concentrations: 0 (control), 4.3, 9.4, 21, 46, and 100 mg BADGE-IPD (#33)/L

Details on test conditions:

Dissolved oxygen levels ranged from 9.0 to 9.1 (i.e., 101 - 102% saturation), temperature ranged from 19 to 20°C, and pH ranged from 7.4 to 7.8. Light intensity ranged from 914 to 1156 lux. Water hardness was 52 mg CaCO3/L in the control and 56 mg CaCO3/L in the highest loading rate. Alkalinity was 30 CaCO3/L in the control water and 40 mg CaCO3/L in the highest loading rate. Conductivity was 179 and 221 µmhos/cm in the control and highest treatment level, respectively.

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

11.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL = 9.41-13.0

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

4.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Following 24 hours of exposure, there was immobility observed in 20, 70, 100, and 100%, of the daphnids at the 9.4, 21, 46, and 100 mg BADGE-IPD (#33)/L loading rates, respectively. At test termination (48-hours of exposure), immobility was observed in 30, 100, 100, and 100% of the daphnids in the 9.4, 21, 46, and 100 mg BADGE-IPD (#33)/L loading rates, respectively. No immobility was observed at the 4.3 mg BADGE-IPD (#33)/L test level or the water control during the conduct of the study. No changes in daphnid behavior or appearance were observed at any test level.

Reported statistics and error estimates:

The acute toxicity values for Daphnia magna exposed to BADGE-IPD (#33) over a 48-hour static exposure period and based on nominal loading rates, were as follows: The 24-hour EL50 was 15.2 mg BADGE-IPD (#33)/L (95% confidence limits 12.2 – 18.9; slope 4.7); the 48-hour EL50 was 11.1 mg BADGE-IPD (#33)/L (95% confidence limits 9.41 – 13.0). The 48-hour NOELR was 4.3 mg BADGE-IPD (#33)/L.

None              

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity values for Daphnia magna exposed to BADGE-IPD (#33) over a 48-hour static exposure period and based on nominal loading rates, were as follows: 24-hour EL50 was 15.2 mg BADGE-IPD (#33)/L (95% confidence limits 12.2 – 18.9; slope 4.7); 48-hour EL50 was 11.1 mg BADGE-IPD (#33)/L (95% confidence limits 9.41 – 13.0). The 48-hour NOELR was 4.3 mg BADGE-IPD (#33)/L.

Executive summary:

The purpose of this study was to evaluate the acute toxicity of BADGE-IPD (#33) to the daphnid, Daphnia magna. Based on the limited solubility of this multi-component test material, water accommodated fractions (WAFs) were prepared and used for exposures (OECD, 2000) at the following loading rates: 4.3, 9.4, 21, 46, and 100 mg BADGE-IPD (#33)/L. The data collected were used to calculate the 24- and 48-hour EL50 values (the loading rate estimated to immobilize 50% of the daphnids after 24 and 48 hours of exposure, respectively) and a 48-hour no-observed-effect-loading rate (NOELR). The acute toxicity values for Daphnia magna exposed to BADGE-IPD (#33) over a 48-hour static exposure period and based on nominal loading rates, were as follows: the 24-hour EL50 was 15.2 mg BADGE-IPD (#33)/L (95% confidence limits 12.2 – 18.9; slope 4.7); the 48-hour EL50 was 11.1 mg BADGE-IPD (#33)/L (95% confidence limits 9.41 – 13.0). The 48-hour NOELR was 4.3 mg BADGE-IPD (#33)/L

Description of key information

Single daphnia magna study

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

11.1 mg/L

Additional information

The purpose of this study was to evaluate the acute toxicity of BADGE-IPD (#33) to the daphnid, Daphnia magna. Based on the limited solubility of this multi-component test material, water accommodated fractions (WAFs) were prepared and used for exposures (OECD, 2000) at the following loading rates: 4.3, 9.4, 21, 46, and 100 mg BADGE-IPD (#33)/L. The data collected were used to calculate the 24- and 48-hour EL50 values (the loading rate estimated to immobilize 50% of the daphnids after 24 and 48 hours of exposure, respectively) and a 48-hour no-observed-effect-loading rate (NOELR). The acute toxicity values for Daphnia magna exposed to BADGE-IPD (#33) over a 48-hour static exposure period and based on nominal loading rates, were as follows: the 24-hour EL50 was 15.2 mg BADGE-IPD (#33)/L (95% confidence limits 12.2 – 18.9; slope 4.7); the 48-hour EL50 was 11.1 mg BADGE-IPD (#33)/L (95% confidence limits 9.41 – 13.0). The 48-hour NOELR was 4.3 mg BADGE-IPD (#33)/L