4,4'-Isopropylidenediphenol, ethoxylated

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

For the purpose of the definitive test the test material was dissolved directly in dechlorinated tap water.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were obtained from Brow Well Fisheries Limited, Hebden near Skipton, Yorkshire, UK and maintained in-house since 17 July 2007.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Test temperature:

The temperature was maintained at approximately 14°C throughout the test.

pH:

The pH across each test concentration was between 7.7 and 8.3. There were no treatment related differences for pH.

Dissolved oxygen:

The dissolved oxygen concentration across each test concentration was between 9.1 and 10.5 mg O2/L. There were no treatment related differences for dissolved oxygen concentration.

Nominal and measured concentrations:

Based on the results of the range-finding tests the following test concentrations were assigned to the definitive test: 10, 18, 32, 56 and 100 mg/L.

Details on test conditions:

At the start of the test, seven fish were placed in each test vessel, at random, in the test preparations. The test vessels were then covered to reduce evaporation and maintained at approximately 14°C in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% Confidence Limits: 52 - 77 mg/L

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 86% to 109% of nominal and so the results are based on nominal test concentrations only.

Validity criteria fulfilled:

not specified

Conclusions:

The 96-hour LC50 based on nominal test concentrations was 64 mg/L with 95% confidence limits of 52 - 77 mg/L. The No Observed Effect Concentration was 32 mg/L.

Executive summary:

The short-term acute toxicity to fish was determined in accordance with the OECD Guideline for Testing of Chemicals 203. The test was carried out on rainbow trout (Oncorhynchus mykiss). Following preliminary range-finding tests, fish were exposed, in groups of seven, to an aqueous solution of the test material over a range of concentrations of 10, 18, 32, 56 and 100 mg/L for a period of 96 hours at a temperature of approximately 14°C under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours. The 96 -hour LC₅₀ based on nominal test concentrations was 64 mg/L with 95% confidence limits of 52 - 77 mg/L. The No Observed Effect Concentration was 32 mg/L.

Description of key information

 The registered substance is not considered acutely toxic to fish, based on the EU Classification, Labelling and Packaging (CLP) Regulation criteria. The key study gave a 96 hour LC50 of 64 mg/l on BisA(1-4.5)EO. The supporting study gave a 96 hour LC50 of 20.8 mg/L on BisA(EO)2.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

64 mg/L

Additional information

Two studies were conducted to assess the short-term toxicity of the test substance to fish. The studies were considered reliable as they were tested on the registered substance according to OECD Testing Guideline 203. The key study gave a 96 hour LC₅₀ of 64 mg/L and a 96 hour NOEC of 32 mg/L for rainbow trout on BPA 1-4.5EO. The supporting study on Oryzias latipes gave a 24 hour LC₅₀ of 23.66 mg/L, a 48 hour LC₅₀ of 20.8 mg/L, a 72 hour LC₅₀ of 20.8 mg/L and a 96 hour LC₅₀ of 20.8 mg/L on BPA 2EO. The NOEC was 8.9 mg/L and the LOEC was 15.9 mg/L.

The 96 hour LC₅₀ values obtained in these studies do not lead to the registered substance being classified as acutely toxic to fish, based on the EU Classification, Labelling and Packaging (CLP) criteria.