A mixture of: N-(4-chlorophenyl)-4-(2,5-dichloro-4-(dimethylsulfamoyl)phenylazo)-3-hydroxy-2-naphthalenecarboxamide; N-(4-chlorophenyl)-4-(2,5-dichloro-4-(methylsulfamoyl)phenylazo)-3-hydroxy-2-naphthalenecarboxamide

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study compliant to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

HPLC

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Test conditions

Hardness:

250 mg/L CaCO3

Test temperature:

19 - 21°C

pH:

initial pH of 7.4 - 8

Dissolved oxygen:

at least 8.1 mg/L

Nominal and measured concentrations:

c (nominal) = 0.1 mg/L. This concentration is also the solubility limit of the test item in water
c (measured) = 0.008 mg/L (mean measured concentration)

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

All biological results are related to the nominal test item concentration (loading rate) of 0.1 mg/L which was clearly above the water solubility limit of the test item in test water (c (measured) = 0.008 mg/L (mean measured concentration)).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In conclusion, the test item had no toxic effects on Daphnia magna up to the water solubility limit of the test item (mean measured concentration of 0.008 mg/L) or up to the loading rate of 0.1 mg/L.

Executive summary:

A limit test was performed to demonstrate that the test item has no toxic effects on Daphnia magna up to the solubility limit of the test item in test water. Thus, the only nominal test concentration (loading rate) was 0.10 mg/L which was above the water solubility limit.

Additionally, a control and a solvent control was tested in parallel.

The measured concentration of the test item in the test medium samples from the start of the test medium renewal periods were between 0.026 to 0.034 mg/L (26 to 34% of the nominal concentration). The losses of test item could be due to adsorption of the test item onto glass surfaces and magnetic stirrer bars during the stirring period of 7 days.

All biological results are related to the nominal test item concentration (loading rate) of 0.10 mg/L which was clearly above the water solubility limit of the test item in test water.

The survival rate of the parent daphnids was not affected at the nominal concentration of 0.10 mg/L. Also the reproduction rate of Daphnia magna was not statistically significantly lower at the nominal test concentration of 0.10 mg/L compared to the control and the solvent control, and no delay of the first brood was observed at the nominal test concentration of 0.10 mg/L compared to the controls. Moreover, no visible abnormalities were observed at the test animals during the test.