4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride

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:

guideline study

Justification for type of information:

The study was performed on the primary hydrolysis product of BPA-DA, 4,4-Bisphenol A Tetra-Acid (BPA-TA; CAS 38103-05-8).

Reason / purpose for cross-reference:

other: read-across target

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Concentrations of DAH were measured in the controls and all test solutions at test initiation and termination. The stock solution concentration was also measured at test initiation.

Details on test solutions:

The stock solution was prepared by adding BPA-DA with acetonitrile (CAN) to dilution water a minimum of 24 hours before its use to ensure complete hydrolysis of BPA-DA to DAH. For the test, each replicate at each exposure concentration was prepared by adding an appropriate aliquot of DAH stock solution to 15 L of dilution water with 0.1 mL/L ACN as a solvent.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Rainbow trout used for testing were obtained as swim-up fry from a government certified hatchery. The fish were held in water of similar quality to that used in the tests a minimum of 7 days before testing. The fish were in good health and free from any apparent malformation prior to testing. They were fed a minimum of 24 hours prior to test start, but were not fed during the test. See the table below for test parameters.

Test type:

static

Total exposure duration:

96 h

Hardness:

21 mg/L as CaCO3

Test temperature:

15.3 to 16.4 °C

pH:

7.4

Dissolved oxygen:

7.1 to 9.9 mg/L (72% to 99% air-saturation)

Nominal and measured concentrations:

0, 8, 16, 32, 64, 128 mg DAH/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 116 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

other: NOAEC

Effect conc.:

116 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

other: LOAEC

Effect conc.:

> 116 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Concentrations of DAH were measured in the controls and all test solutions at test initiation and termination. The 62.2 mg/L test solution at test termination was analysed in duplicate and the relative difference between the two analyses was 1%. The average observed/nominal DAH concentration ratio in the matrix spiked samples was 103 ± 0 %. Measured DAH concentrations were 78 to 96% of adjusted nominal DAH concentrations at test initiation and 71 to 95% of adjusted nominal DAH concentrations at test termination. Mean measured DAH concentrations were 75 to 94% of nominal DAH concentrations. The mean measured concentrations were used to calculate the test endpoints as the measured test solution concentrations were not within 80 to 120% of the adjusted nominal concentrations.

The toxicity test met the test validity criteria, as there was no mortality in the controls, constant conditions were maintained during the test, and the dissolved concentrations were >60% saturation. In addition, the water quality measurements (e.g. pH, dissolved oxygen) were within the tolerance limits of the test organisms. At 96-h, no fish had died in any of the treatment groups. All surviving fish appeared normal throughout the exposure period. The LC50, based on mean measured DAH concentrations, was >116 mg DAH/L. Based on visual inspection of the data, the NOAEC was 116 mg DAH/L, and the LOAEC was >116 mg DAH/L.

Results with reference substance (positive control):

The separate study conducted with phenol indicated that the test organisms responded normally to the reference substance.

Sublethal observations / clinical signs:

Adjusted Nominal DAH Concentration (mg/L)	Test Initiation^a  (mg/L)	Test Termination^a  (mg/L)	Mean^a  (mg/L)
Control	Less than DL^b	Less than DL^b	0
Solvent Control	Less than DL^b	Less than DL^b	0
7.78	6.09 (78%)	5.53 (71%)	5.81 (75%)
15.6	12.2 (78%)	11.9 (76%)	12.1 (77%)
31.1	28.6 (92%)	28.8 (93%)	28.7 (92%)
62.2	55.3 (89%)^c	59.0 (95%)	57.2 (92%)
124	118 (96%)	114 (92%)	116 (94%)
15,562 (Stock)	16,040 (103%)	N/A	N/A

^a Measured concentrations as a percentage of the adjusted nominal concentrations are listed in parentheses.

^b The detection limit was 3 mg/L.

^c Mean of duplicate analysis (59.4 and 58.7 mg/L).

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study, the 96 h LC50 and NOAEC in Oncorhynchus mykiss were >116 and 116 mg/L, respectively.

Executive summary:

The acute toxicity of the read-across test material to Oncorhynchus mykiss was investigated in a study conducted using methodology equivalent to OECD 203 under GLP conditions (Vizon SciTec Inc., 2005).

Fish were exposed to nominal concentrations of 0, 8, 16, 32, 64, 128 mg/L under static conditions for 96 hours.

At 96-h, no fish had died in any of the treatment groups. All surviving fish appeared normal throughout the exposure period. 

Under the conditions of this study, the 96 h LC50 and NOAEC in Oncorhynchus mykiss were >116 and 116 mg/L, respectively.

Description of key information

Under the conditions of this study, the 96 h LC50 and NOAEC in Oncorhynchus mykiss were >116 and 116 mg/L, respectively.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

116 mg/L

Additional information

The acute toxicity of the test material to Oncorhynchus mykiss was investigated in a study conducted using methodology equivalent to OECD 203 under GLP conditions (Vizon SciTec Inc., 2005).The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Fish were exposed to nominal concentrations of 0, 8, 16, 32, 64, 128 mg/L under static conditions for 96 hours.

At 96-h, no fish had died in any of the treatment groups. All surviving fish appeared normal throughout the exposure period. 

Under the conditions of this study, the 96 h LC50 and NOAEC in Oncorhynchus mykiss were >116 and 116 mg/L, respectively.