2-Acetone, polymer with phenol

Short-term toxicity to aquatic invertebrates

Administrative data

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:

other: The study was conducted according to O.E.C.D. Testing Guideline No. 202 with GLP compliance.

Data source

Reference

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Acetone, polymer with phenol

EC Number:

500-086-4

EC Name:

2-Acetone, polymer with phenol

Cas Number:

35238-34-7

Molecular formula:

(C6H6O.C3H6O)x

IUPAC Name:

2-Propanone, polymer with phenol

Constituent 2

Reference substance name:

2-Acetone polymer with phenol

IUPAC Name:

2-Acetone polymer with phenol

Constituent 3

Reference substance name:

BPA-Tars

IUPAC Name:

BPA-Tars

Details on test material:

As per IUCLID5 Sections 1.1. - 1.4.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples were collected once for measurment of BPA-Tars at the termination of exposure, 48 hr.

Test solutions

Vehicle:

yes

Details on test solutions:

Reconstituted water (so-called 'M4 medium') was used for the preparation of stock and test substance solutions. The appropriate amount of BPA-Tars was added to 1 litre of dilution water followed by treated for one hour in an ultrasonic bath and stirred for 24 h on magnetic stirrers. The nominal concentrations were: 2.5, 5, 10, 20 and 40 mg/L.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Source : Strain of Bundesgesundheitsamt Berlin

Maintenance and Acclimatisation : A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

The total hardness of the dilution water, measured at test start, was 14.8°dH (= 264 mg/L CaCO3).

Test temperature:

19.4 to 19.7 °C

pH:

8.0

Dissolved oxygen:

> 3 mg/L

Salinity:

No data, freshwater

Nominal and measured concentrations:

0 (control) and 2.5, 5, 10, 20 and 40 mg/L

Details on test conditions:

50 mL glass beakers covered with watch glasses holding 10 neonate Daphnids and 20 mL of test medium were used for exposure. There were 5 test concentrations plus 1 control and 2 replicates per concentration/control. There was no feeding of the Daphnids during the exposure period. Exposure was under a static system for 48 hr without areation.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

9.81 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

8.27 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The results are expressed in terms of initial concentrations. Effective concentrations ranged from 36.7 – 75.2% of nominal values at 0 hours, and from 51.6 – 73.6% of nominal values at 48 hours, respectively. Based on initial concentrations measured concentrations ranged from 94.3 – 99.1% of initial values after 24, 48 hours of exposure respectively. Immobilization of the Daphnids was observed at nominal test substance concentrations of 20 mg/L and higher. Immobilization was 100% at 24 hr at the high nominal dose level of 40 mg/L.

Reported statistics and error estimates:

Probit analysis was ised to estimate the EC50 values.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The estimated EC50 values for BPA-Tars in this study were 9.8 mg/L at 24 hr of exposure and 8.3 mg/L at 48 hr. These data suggest that Classification and Labeling as Toxic to aquatic organisms is necessary.

Executive summary:

2 -Acetone polymer with phenol (BPA-Tars) was evaluated for acute toxicity to Daphnia magna by an O.E.C.D. No. 202 Test Guideline study with GLP compliance. The estimated EC50 values for BPA-Tars in this study were 9.8 mg/L at 24 hr of exposure and 8.3 mg/L at 48 hr. These data suggest that Classification and Labeling of BPA-Tars as Toxic to aquatic organisms is necessary.