Salts of 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthenium chloride and 4-{[1-hydroxy-6-({[5-hydroxy-6-(phenyldiazo)-7-sulfonaphthalen-2-yl]carbamoyl}amino)-3-sulfonaphthalen-2-yl]diazo}benzoic acid (2:1)

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 2008-08-12 to 2008-08-14

Reliability:

1 (reliable without restriction)

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:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

not applicable

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

at the start and after 48 h at the end of the test

Test solutions

Vehicle:

no

Details on test solutions:

not applicable

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Straus) not first brood progeny
Age at Test Start: Less than 24 hours old
Sex: Female
Origin: National Institute of Public Health, Hungary
Breeding Conditions:
The Daphnia were bred in the laboratories of LAB Research Ltd. under similar temperature and light conditions as in the test, and in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test. The test animals were fed daily with a few mL of centrifuged algae suspension (Pseudokirchneriella subcapitata).

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 d

Post exposure observation period:

not applicable

Test conditions

Hardness:

c(CaCO3) of water: 144 mg/L

Test temperature:

19.9 – 20.2 °C

pH:

pH 7.79 to 7.89

Dissolved oxygen:

6.3 mg/L or higher

Salinity:

not applicable

Nominal and measured concentrations:

Concentration Levels in the main test:
Nominal (mg/L): 0.019;0.034;0.070; 0.128; 0.26
Measured at the end of the test (mg/L): 0.008;0.018;0.037; 0.083; 0.24
Mean (mg/L): 0.012; 0.025; 0.051; 0.103; 0.25
The analytically determined mean test item concentrations in the analysed test media varied in the range from 102 % to 119 % at the start and from 52 % to 97 % at the end of the study in comparison to the nominal value.

Details on test conditions:

not applicable

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.012 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 0.012 - < 0.03 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

0.012 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.03 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % conf. limits: 0.024 – 0.037

Effect concentrations 5

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

0.103 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

0.04 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % conf. limits: 0.033-0.051

Details on results:

not applicable

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

not applicable

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Conclusions:

In this 48-hour static acute toxicity test to Daphnia magna with F 213 Red the 48 h EC50 value was 0.030 mg/L (Probit analysis), based on measured concentrations. The overall NOEC was determined to be 0.012 mg/L, based on measured concentrations.

Executive summary:

The analytically determined mean test item concentrations in the analysed test media varied in the range from 102 % to 119 % at the start and from 52 % to 97 % at the end of the study in comparison to the nominal value. The 48h-NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours), respectively the 48h-EC0 of F 213 Red to Daphnia magna was determined to be 0.012 mg test item/L. The 48h-EC50 was calculated to be 0.030 mg test item/L and the 48h-EC100 was determined to be 0.103 mg test item/L.