4,4'-Isopropylidenediphenol, ethoxylated

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Static method, with samples for analysis removed at time 0 and 48 hours.

Vehicle:

yes

Details on test solutions:

The daphnia were exposed to aqueous solutions of the test material at a concentration of 100 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

Test organisms (species):

Daphnia magna

Details on test organisms:

The test was carried out using 1st instar Dapnia magna derived from in-house laboratory cultures.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

Theoretical hardness 250 mg/L as CaCO3.

Test temperature:

The test vessels were maintained in a temperature controlled room at approximatley 21°C.

pH:

The reconstitued water used to dissolve the test material had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl.

Dissolved oxygen:

8.5 - 8.9 mg/L

Salinity:

Fresh water

Nominal and measured concentrations:

Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 108% to 113% of the nominal value and so the results are based on nominal test concentrations only.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

There was no immobilisation in 20 daphnids exposed to a test concentration of 100 mg/L for a period of 48 hours. The No Observed Effect Concentration after 24 and 48 hours exposure was 100 mg/L. The No Observed Effect Concentration is based upon zero immobilisation at this concentration.

Results with reference substance (positive control):

The 48 hour EC50 for the reference material to Daphnia magna based on nominal concentrations was 0.75 mg/L with 95% confidence limits of 0.56-1.0 mg/L. The No Observed Effect Concentration was 0.56 mg/L. The results from the positive control with potassium dichromate were within the normal range for this reference material. The mean 48 hour EC50 value calculated from all positive controls was 0.81 mg/L (sd = 0.21).

Table 1: Summary results

Nominal concentration (mg/L)	Cumulative Immobilised Daphnia (Initial population: 5 per replicate)
	24 hours			48 hours
	No. Per Replicate	Total	%	No. Per Replicate	Total	%
Control      R1 R2 R3 R4	0 0 0 0	0	0	0 0 0 0	0	0
100           R1 R2 R3 R4	0 0 0 0	0	0	0 0 0 0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated and gave a 24 hour and 48 hour EC50 of > 100 mg/L and a No Observed Effect Concentration of 100 mg/L at 24 hours and 48 hours.

Executive summary:

The acute toxicity of the test substance to Daphnia magna was determined in accordance with the OECD Guideline for Testing of Chemicals 202. Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test material at a concentration of 100 mg/L for 48 hours at a temperature of approximately 21°C under static conditions. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L. The 24 hour and 48 hour EC₅₀ for the test material to Daphnia magna based on nominal test concentrations was > 100 mg/L and correspondingly the No Observed Effect Concentration was 100 mg/L at 24 hours and 48 hours.

Description of key information

 The registered substance is not considered acutely toxic to aquatic invertebrates, based on the EU Classification, Labelling and Packaging (CLP) criteria. The key study gave a 48 hour EC50 of >100 mg/L on BisA(5)EO. The supporting study gave a 48 hour EC50 of >33.58 mg/L on BisA(2)EO but this value was not considered as it was the highest concentration tested and did not induce immobilisation. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

100 mg/L

Additional information

Two studies were conducted to assess the acute toxicity of the test substance to aquatic invertebrates. Both tests used Daphnia magna as the test species and were considered reliable as they were conducted on BPA-2EO and BPA-5EO respectively according to OECD Testing Guideline 202 or an equivalent method. The key study gave a 24 hour EC50 >100 mg/L and a 48 hour EC50 >100 mg/L, and a 24 hour and 48 hour NOEC of 100 mg/L on BPA-5EO as it was the highest concentration tested and it did not induce adverse effects. The supporting study gave a 48 hour EC50 >33.58 mg/L and a 48 hour NOEC greater than or equal to 33.58 mg/L on the read-across substance BPA-2EO as it was the highest concentration tested and it did not induce adverse effects.

The 48 hour EC50 values obtained in these studies do not lead to the registered substance being classified as acutely toxic to aquatic invertebrates, based on the EU Classification, Labelling and Packaging (CLP) criteria.