5-(4-hydroxyphenyl)imidazolidine-2,4-dione

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:

end on XXX

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

5-(4-hydroxyphenyl)imidazolidine-2,4-dione

EC Number:

219-340-8

EC Name:

5-(4-hydroxyphenyl)imidazolidine-2,4-dione

Cas Number:

2420-17-9

Molecular formula:

C9H8N2O3

IUPAC Name:

5-(4-hydroxyphenyl)imidazolidine-2,4-dione

Details on test material:

- Name of test material (as cited in study report): p-Hydroxy-phenylhydantoin
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: will be tested within this study (see analytical section)
- Storage condition of test material: at room temperature, protected from light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 1, 2, 4, 8 and 10 mg/L
- Sampling method: data not available
- Sample storage conditions before analysis: concentrations were measured immediately after sampling, as it was determined that the test item was not stable upon freezing and thawing procedure originally performed with the test treatments – the test item disappeared during storage at -18°C.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION:
The test item was introduced into the test solution in one step.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna STRAUS (clone 5)
- Source: laboratory bred
- Age at study initiation: not older than 24h
- Method of breeding: data not available
- Feeding during test: no

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:

data not available

Test temperature:

20.7 to 21.6°C

pH:

t0: 9.18 (control) and 8.85 (10 mg/L)
t48: 9.13 (control) and 8.56 (10 mg/L)

Dissolved oxygen:

between 5.2 and 8.7 mg O2/L

Salinity:

not applicable (freashwater)

Nominal and measured concentrations:

nominal: 0, 1, 2, 4, 8, 10 mg/L
measured at t0 : 0, 0.950, 2.230, 4.480, 7.840, 9.080 mg/L
measured at t48: 0, 0.820, 0.060, 0.530, 1.230, 1.670 mg/L
geom. mean of t0 vs. t48h: 0.88, 0.37, 1.54, 3.11, 3.89 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL carboys with glass stoppers made of glass
- Type: closed (stoppers made of glass were used in order to minimize losses due to evaporation)
- Aeration: test vessel was gently agitated
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
The stock solutions were individually prepared in ultrapure water.
Medium: dilution water according to Elendt M4.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h of light and 8h of darkness
- Light intensity: data not available

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The effect of the test item to the animals was examined by the determination of the swimming behaviour of the daphnia. For this purpose the respective test vessel was gently agitated. Daphnia showing no swimming within 15 sec. were considered as immobile. Moving of antenna was not considered as swimming.
The effect was determined at 24 and 48h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: between 1.25 and 2
- Range finding study
- Test concentrations: an "enlarged screening-test" was performed in order to fix the concentration range of the test item for the main test, because the results of the first screening test were not clear enough. This enlarged screening was prepared with following concentrations of the test item: 1.0, 5.0, and 10.0 mg, respectively.
- Results used to determine the conditions for the definitive study: 100% mortality was observed at 5 and 10 mg/L after 48h (0% at 1 mg/L)

Reference substance (positive control):

yes

Remarks:

potassium dichromate (prior to beginning of the test)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.43 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Remarks on result:

other: no limits given

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.48 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Remarks on result:

other: no limits given

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.88 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Effect concentrations 4

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

0.37 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks:

swimming behaviour

Details on results:

Under the conditions used for the test, immobilisa¬tion of the daphnia was observed at nominal concentrations beginning with 2 mg/L.
As a conclusion of the analytical part of this study, it can be concluded that the test item was not stable upon freezing and thawing procedures and not stable during incubation in the test. Recoveries of the concentrations determined after 48h were in the range of 3.0 to 82.0 % of those determined at time t0. Based on this, the reported effect concentrations refer to mean (geometric mean) of the measured concentrations. The test is considered valid as all criterions for validity were met.

Results with reference substance (positive control):

The value of the EC50 (24h) was 1.06 mg/L potassium dichromate.
This value is in accordance with the recommendations given in OECD Guideline 202.

Reported statistics and error estimates:

The statistical calculations were done according to the Guideline using the commercial computer program ToxRatPro Version 2.10.

Any other information on results incl. tables

Table 1: result (Main test)

Nominal Concentration of the testitem(mg/L)		Ratio immobilised Daphnia [%]		pH-Value		O2-Content [mg O2/L]		Temperature [°C]
		24h	48h	t0	48h	t0	48h	t0	48h
Control (0)		0 [0/20]	0 [0/20]	9.18	9.13	8.7	7.9	20.8	21.4
1		0 [0/20]	5 [1/20]	9.12	9.02	6.6	6.9	20.7	21.3
2		0 [0/20]	75 [15/20]	9.10	8.97	6.3	6.8	20.7	21.3
4		80 [16/20]	100 [20/20]	9.07	8.95	6.2	6.3	20.8	21.4
8		100 [20/20]	100 [20/20]	8.93	8.70	6.9	5.8	21.6	21.6
10		100 [20/20]	100 [20/20]	8.85	8.56	6.9	5.2	21.6	21.6

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

p-Hydroxy-phenylhydantoin:
- 48h NOEC = 0.88 mg/L
- 48h EC50 = 0.48 mg/L
(mean measured concentrations)

Executive summary:

p-Hydroxy-phenylhydantoin was tested for acute toxicity towards Daphnia according to OECD-Test Guideline 202 (GLP). In order to in­vestigate the influence of the test item towards the daphnia the swimming behaviour of the animals was recorded. Under the conditions used for the test, immobilisation of the daphnia was observed at nominal concentrations beginning with 2 mg/L. The following EC-values were calculated on basis of the nominal concentrations being tested:

 

EC-Values	Test Results on the Basis of Nominal Concentrations
	t24h	t48h
NOEC	2.00 mg/L	1.00 mg/L
LOEC	4.00 mg/L	2.00 mg/L
EC10	3.11 mg/L [no limits given]	1.12 mg/L [0.77 – 1.34]
EC20	3.28 mg/L [no limits given]	1.27 mg/L [0.96 – 1.49]
EC50	3.62 mg/L [no limits given]	1.63 mg/L [1.38 – 1.92]

 

EC-Values	Test Results on the Basis of Mean Measured Concentrations (geometric mean)
	t24h	t48h
NOEC	0.37 mg/L	0.88 mg/L
LOEC	1.54 mg/L	0.37 mg/L
EC10	1.27 mg/L [no limits given]	n.d.
EC20	1.32 mg/L [no limits given]	n.d.
EC50	1.43 mg/L [no limits given]	0.48 mg/L [no limits given]

Values in brackets indicate the 95% confidence limits. As a conclusion of the analytical part of this study, it can be concluded that the test item was not stable upon freezing and thawing procedures and not stable during incubation in the test. Recoveries of the concentrations determined after 48h were in the range of 3.0 to 82.0 % of those determined at time t₀. Based on this, the reported effect concentrations refer to mean (geometric mean) of the measured concentrations.The test is considered valid as all criterions for validity were met.