2,2''-dihydroxy-4,4''-(2-hydroxy-propane-1,3-diyldioxy)dibenzophenone

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

Study period:

1996-11-12 to 1996-11-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

according to Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67 / 548/EEC).

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

424-210-0

EC Name:

-

Cas Number:

23911-85-5

Molecular formula:

C29 H24 O7

IUPAC Name:

2-benzoyl-5-[3-(4-benzoyl-3-hydroxyphenoxy)-2-hydroxypropoxy]phenol

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: water samples taken from the solvent control and the 0.10 mg/L test group (replicates R1 - R2 and R3 - R4 pooled) at 0 and 48 hours for quantitative analysis

Test solutions

Vehicle:

yes

Remarks:

dimethylformamide

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An amount of test material (100 mg) was dispersed in dimethylformamide and the volume adjusted to 10 mL to give a 100 mg/10 mL solvent stock solution. A serial dilution was made from this to give a second solvent stock solution of 10 mg/10 mL. An aliquot (500 µL) of the second solvent stock solution was dispersed in reconstituted water and the volume adjusted to 5 litres to give the 0.10 mg/L test concentration.
- Controls: negative control, solvent control
- Chemical name of vehicle: dimethylformamide
- Concentration of vehicle in test medium: 100 µL/L
- Test concentration separation factor: not applicable (limit test)
- Evidence of undissolved material: no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation: less than 24 hours
- Stage and instar at study initiation: first instar
- Method of breeding: laboratory culture in polypropylene vessels containing approximately 2 litres of reconstituted water at a temperature of 21 °C
- Source: laboratory culture originating from a strain supplied by the lnstitut National de Recherche Chimique Appliquée (IRCHA), France
- Feeding during test: no

ACCLIMATION
- Acclimation period: none, culturing conditions same as test

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS: gravid adults isolated 24 hours prior to the initiation of the test, young daphnids produced overnight removed for testing

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

post exposure observation not performed

Test conditions

Hardness:

270 mg CaCO3/L

Test temperature:

20 °C at 0 and 48 hrs and 21°C at 24 hrs (measured for all replicates of control, solvent control and treatment solution)

pH:

7.8 (measured for all control solution replicates at 0 hrs) and 7.9 (measured at 0 and 48 hrs for solvent control and treatment solution replicates and at 48 hrs for control solution replicates)

Dissolved oxygen:

8.2-8.3 mg/L at 0 hours and 7.4-7.6 mg/L at 48 hours for control, solvent control and treatment solution replicates

Salinity:

not applicable

Conductivity:

not specified

Nominal and measured concentrations:

nominal: 0.10 mg/L; measured: 0.076 and 0.095 mg/L (mean measured after 48 and 0 hours, respectively)

Details on test conditions:

TEST SYSTEM
- Test vessel: jars
- Type: closed
- Material, nominal volume, fill volume: glass, nominal volume: 250 mL; fill volume: 250 mL
- Volume of solution: 250 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration: 4
- No. of vessels per control: 2
- No. of vessels per vehicle control: 2


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: not specified

EFFECT PARAMETERS MEASURED: Any immobilisation or adverse reactions to exposure were recorded ar.24 and 48 hours after the start of exposure. The criterion of effect used was That Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation.

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Test concentrations: 0.010 and 0.10 mg/L
- Results used to determine the conditions for the definitive study: Yes. The results showed no immobilisation at the test concentrations of 0.010 and 0.10 mg/L. During preliminary solubility work a precipitate of test material was observed after addition of the solvent stock solution to water at test concentrations in excess of 0.10 mg/L thereby indicating 0.10 mg/L to be the maximum limit of water solubility under these test conditions. Based on this information, a single test concentration of four replicates, of 0.10 mg/L was selected for the definitive study. This experimental design conforms to a "Limit test" to confirm that at the highest attainable test concentration of 0.10 mg/L, no immobilisation or adverse reactions to exposure were observed.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 0.1 mg/L

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.1 mg/L

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 0.1 mg/L

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 0.1 mg/L

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: none
- Mortality of control: no
- Other adverse effects control: no
- Immobilisation of control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

reference control not performed

Reported statistics and error estimates:

not applicable since no effects were detected

Any other information on results incl. tables

Table 1: Cumulative immobilisation data in the definitive study

Nominal concentration (mg/L)	Replicate	Cumulative immobilised Daphnia
		24 hours			48 hours
		No. Per replicate	Total	%	No. Per replicate	Total	%
Control	R1	0	0	0	0	0	0
	R2	0
Solvent control	R1	0	0	0	0	0	0
	R2	0
0.10	R1	0	0	0	0	0	0
	R2	0
	R3	0
	R4	0

R1- R4:Replicates 1-4

 

Table 2: Physicochemical measurements

Nominal concentration (mg/L)	0 hours			24 hours	48 hours
	pH	mg O2/L	T (°C)	T (°C)	pH	mg O2/L	T (°C)
Control	7.8	8.2	20.0	21.0	7.9	7.4	20.0
	7.8	8.2	20.0	21.0	7.9	7.4	20.0
Solvent control	7.9	8.3	20.0	21.0	7.9	7.4	20.0
	7.9	8.3	20.0	21.0	7.9	7.5	20.0
0.10	7.9	8.3	20.0	21.0	7.9	7.6	20.0
	7.9	8.3	20.0	21.0	7.9	7.6	20.0
	7.9	8.3	20.0	21.0	7.9	7.6	20.0
	7.9	8.3	20.0	21.0	7.9	7.6	20.0

R1- R4:Replicates 1-4

 

Table 3: Analytical results

Samples	Nominal concentration (mg/L)	Concentration found (mg/L)	Expressed as a % of nominal concentration
0 hours	Solvent control	< LOQ	-
	0.10 R1 - R2	0.0978	98
	0.10 R3 - R4	0.0928	93
48 hours	Solvent control	< LOQ	-
	0.10 R1 - R2	0.0715	72
	0.10 R3 - R4	0.0801	80

LOQ: Limit of quantitation

R1 - R4: Replicates 1-4

 

VALIDITY OF TEST

In the control, including the control containing the solubilising agent, none of the daphnids were immobilised. The dissolved oxygen concentration at the end of the test was clearly ≥ 3 mg/l in control and test vessels. Hence, the study is considered valid according to the criteria given in the current OECD TG 202.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In Daphnia sp. Acute Immobilisation Test according to OECD TG 202 with Daphnia magna, the 48 EC50 of the test item was determined to be > 0.10 mg/L.

Executive summary:

To assess the acute toxicity of the test item to Daphnia magna an Acute Immobilisation Test according to OECD TG 202 (1984) was carried out in compliance with the GLP criteria. Following a preliminary range-finding study, forty daphnids (4 replicates of 10 animals) were exposed to an aqueous dispersion of the test material at a limit concentration of 0.10 mg/L for 48 hours under static test conditions. The test solutions were prepared using dimethylformamide as solvent. In addition, a negative control (without test item and solvent) and a solvent control (2 replicates with 10 animals each) were performed. The solvent concentration was 100 µL/L, which is considered a reasonable working maximum concentration in compliance with current OECD Guideline 23. The test concentration of 0.10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test. The test item concentration was analytically verified using a HPLC method.  Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours. In the control, including the control containing the solubilising agent, no daphnids were immobilised. The dissolved oxygen concentration at the end of the test was clearly ≥ 3 mg/l in control and test vessels. The study is hence considered valid in accordance with the criteria given in the current OECD TG 202. Analysis of the test solutions at 0 and 48 hours showed the overall mean measured test concentration, calculated from the results of all sampling occasions, to be near nominal and so the results are based on nominal test concentrations only. The 48-Hour EC50 for the test material to Daphnia magna based on nominal test concentrations was greater than 0.10 mg/L and correspondingly the No Observed Effect Concentration was greater than or equal to 0.10 mg/L. As a result, the 48 EC50 of the test item was determined to be > 0.10 mg/L (nominal), which corresponds to the highest test concentration attainable in the test medium.