2'-[2,4-dichloro-5-(1-methylethoxy)phenyl]-2,2-dimethylpropionohydrazide

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:

From 17 June 2003 (beginning of the study) to 19 June 2003 (end of the study)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This test was performed according to international guidelines without GLP statement. All validity criteria were fulfilled. However, this study corresponds to a screening test.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

, 4th April 1984

Deviations:

yes

Remarks:

, only a screening test was performed.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

, 31st July 1992

Deviations:

yes

Remarks:

, only a screening test was performed.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2'-[2,4-dichloro-5-(1-methylethoxy)phenyl]-2,2-dimethylpropionohydrazide

EC Number:

257-027-8

EC Name:

2'-[2,4-dichloro-5-(1-methylethoxy)phenyl]-2,2-dimethylpropionohydrazide

Cas Number:

51167-18-1

Molecular formula:

C14H20Cl2N2O2

IUPAC Name:

N'-(2,4-dichloro-5-isopropoxyphenyl)-2,2-dimethylpropanehydrazide

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): HTMA [1-TRIMETHYLACETYL-2-(2,4-DICHLORO-5-ISOPROPOXYPHENYL)-HYDRAZINE]
- Molecular weight: 319 mg/L
- Substance type: brown orange-colored pieces
PHYSICO-CHEMICAL PROPERTIES
- Water solubility: 40 ppm
- Density: 1.25
- Physical state: solid
- Stability under test conditions: no data
- Storage condition of test material: no data

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

Not applicable

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared by further dilution of the stock solution with M4 reconstituted water or directly from the test item. A solution containing a maximum of 100 mg/L of the test item plus two other range-finding concentrations were prepared. Test vessels were filled directly from the test solution containers immediately after preparation.
- Eluate: M4 reconstituted water
- Control: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain: Clone 5
- Source: Centre Technique du Bois et de l'Ameublement, 75012 Paris, France
- Age at study initiation (mean and range, SD): between 6 and 24 hours
- Weight at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): no data
- Valve height at study initiation, for shell deposition study (mean and range, SD): no data
- Peripheral shell growth removed prior to test initiation: no data
- Method of breeding: no data
- Feeding: culture animals were fed with a diet of between 0.1 and 0.2 mg of carbon per Daphnia per day, in the form of the algal strain Scenedesmus subspicatus which is cultured at CIT. Animals were not fed during the test.

ACCLIMATION
none

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

none

Post exposure observation period:

None

Test conditions

Hardness:

255 mg CaCO3/L

Test temperature:

19.5-20.5°C

pH:

7.57-7.89

Dissolved oxygen:

97-99%

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal loading rates concentrations: 0, 1, 10 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 2L borosilicate tanks
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: at least 10 mL of water is provided for each animal.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water M4

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light/ 8h dark cycle
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization was recorded at 0, 24 and 48h by gently shaking the test vessel. If an animal is incapable of swimming within 15 seconds after it has been disturbed, it will be considered immobile.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 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.:

> 10 - < 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

See table in "Any other information on results incl. tables" section.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

None

Any other information on results incl. tables

Table 6.1.3/1: Immobilization data

	Immobilization (n animals out of 5) at each nominal loading rate (mg/L)
	0				1				10				100
	Test vessels				Test vessels				Test vessels				Test vessels
	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4
0h	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
24h	0	0	0	0	0	0	0	0	0	0	0	0	5	4	3	3
48h	0	0	0	0	0	0	0	0	0	0	0	0	5	5	5	5

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The highest concentration resulting in no immobilization (NOEC) at 48 hours was 10 mg/L. The 48h-EC50 was estimated to be between 10 and 100 mg/L.

Executive summary:

This test was performed according to international guidelines without GLP statement.

The objective of this screening test is to assess the acute toxicity of the test substance in Daphnia magna, in a 48 hour static test.

3 nominal loading rates concentrations (1, 10 and 100 mg/L) were used plus one control. No analytical monitoring was performed and the immobilization of daphnid was recorded throughout the test, at 0, 24 and 48h.

At the nominal loading rates of 1 and 10 mg/L, 0% immobilization was observed. However, at the highest loading rate of 100 mg/L, 100% immobilization was observed.

Based on these results, the highest concentration resulting in no immobilization (NOEC) at 48 hours was 10 mg/L. The 48h-EC50 was estimated to be between 10 and 100 mg/L.

All validity criteria were fulfilled. This study corresponds to a screening test and no defined EC50 value was determined.