REAKTIV-ORANGE DYPR 934

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:

1999-04-20 to –1999-04-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to GLP and guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

-Name of test material (as cited in study report): Reaktiv-Orange DYPR934

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentration: 100 mg/L
- Sampling method: According to the study method; i.e. SOP 2030-7000203-98 D
- Sample storage conditions before analysis: As recommended in the guideline

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna STRAUS, parthenogenetic females
Origin of species: cloned at the Federal Health office (BGA) in Berlin
Test animals: Laboratory bred at Bayer AG Leverkusen
Age of test animals: 0-24 h
Keeping conditions: SOP 2030-7700203-98 D

Keeping water: M4-Medium according to Elendt and BGA (1992)

SEPARATION OF THE TEST ANIMAL ACCORDING TO SIZE BEFORE START OF TEST
1st sieving on: 1999.04.19 at 2.00 p.m.
2nd sieving on: 1999-04-20 at 8.00 a.m.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

Test parameters during the test: -Oxygen [mg/L]-pH-Water temperature [°C] number of immobile daphnids after 24 h (compare SOP 2030-7000203-96 D) and 48 h

Post exposure observation period:

Analysis of the only test concentration plus a control test at test start and after 48 h of exposure.

Test conditions

Hardness:

15.4 mg CaCO3/L

Test temperature:

19.9 to 20

pH:

7.9

Dissolved oxygen:

8.6 mg/L

Salinity:

freshwater

Nominal and measured concentrations:

Nominal concentration: 100 mg/L

Details on test conditions:

No Deviations from the SOPs
STUDY CONDITIONS (SOP 2030-7000203-98 D)
OPERATING CONDITIONS: Static system in accordance with above study method.
Photoperiod: 16hours light / 8hours dark
TEST PROCEDURE:
-cylindrical test vessels
-diameter 4.0 cm, height 6.5 cm
-20 mL test medium
-not ventilated

Method of administration: direct weighing (SOP 2030-6600401-96 D)
Test concentration/s (mg/L): 100
Solubilizer or other auxiliaries: none
Control/Water for dilution: M4-Medium according to Elendt and BGA (1992)
Test parameters during the test: oxygen [mg/L], pH, water temperature (°C), number of immobile daphnids after 24hours (compare SOP 2030-7000203-98 D) and 48 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 99.1

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: (Test substance; including inorganic components)

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

> 67.4 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

other: (organic components)

Details on results:

Mortality=0
- Mortality of control=0
-Other adverse effects control:0

EC10 > 100 mg/l (48 h, Daphnia magna)

Any other information on results incl. tables

NOEC: 67.4 mg/L mg/l  
Maximum test concentration causing no mortality: 100 mg/L(nominal).  
Minimum test concentration causing 100% mortality: NA

STUDY EVALUATION –TEST SUBSTANCE (SOP 2030-7001202-96 D, 2030-1110101-96 D, 2030-7000203-98D) No. parallel solutions : 2 Test volume : 20 mL No. daphnids per vessel: 10
Nominal Concentration test substance [mg/L]	Results after 24 hours and 48 hours
	Imobile daphnids absolute %				Oxygen [mg/L] 48 h	pH 48 h	Temperature [°C] 48 h
Control	0	0	0	0	8.6	7.9	20.0
100	0	0	0	0	8.6	7.9	19.9

Remark: the value of the abiotic parameters (oxygen, pH and temperature) were determined from the total of the parallel solutions.

Study results

after 24 hours	After 48 hours
Nominal concentration	Arithmetic mean of analytical values
EC0^: >= 100 mg/L	>= 67.4 mg/L (organic components) >= 99.1 mg/L (test substance; including inorganic components)

 

The above test result refers to a concentration of the test substance, which was calculated directly from analytically determined TOC values. According to the relevant product informations, 1 mg/L TOC equals to 2.75 mg/L of the organic components of the test substance mw: 685 g/mol and 766 g/mol). As these organic components correspond to 68% of the molecular weight of the test substance, 100 mg/L of the test substance equal to 25 mg/L of organic C. Thus the above analytical values indicate a very good recovery rate.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The values of the abiotic parameters (oxygen, pH and temperature) were determined from the total volume of the parallel solutions. The validity criteria were fulfilled.

Conclusions:

The above analytical value indicates a very good recovery rate. Therefore the results are considered as valid.

Executive summary:

The acute Daphnia toxicity of Reaktiv-Orange DYPR 934 was tested in a static system within 24 and 48 h respectively according to SOP 2030 -7000203 -98 D which is similar to the EU C2 (acute toxicity to daphnia).

The values of the abiotic parameters (oxygen, pH and temperature) were determined from the total volume of the parallel solutions.

The validity criteria were fulfilled. The analytical value indicates a very good recovery therefore the following results are considered as valid:

Study results

after 24 hours	After 48 hours
Nominal concentration	Arithmetic mean of analytical values
EC0^: >= 100 mg/L	>= 67.4 mg/L (organic components) >= 99.1 mg/L (test substance; including inorganic components)