Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 August 1993 to 15 November 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

Limit test : 3 concentrations tested

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Remarks:

OECD Good laboratory Regulations and the Procedures and Principles of Good Laboratory Praxis in Switzerland

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 287380.26
- Expiration date of the lot/batch: Nov 1997

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility of the test substance in the solvent/vehicle: 50 g/l (in water)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Based on a pretest, the test concentrations were chosen as 58/ 100 and 180 mg/L nominal.

Vehicle:

no

Details on test solutions:

Test concentrations:
Based on a pretest, the test concentrations were chosen as 58, 100 and 180 mg/L nominal.

Analysis of the Test substance:
The concentration of the test substance at the beginning and at the end of the test was analysed by the Analytical Services K, Textile Dyes Division.
All test medium samples for the analytical determinations were taken after mixing of the test solutions.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia
- Strain: Daphnia magna
- Source: Product Ecology TF, Textile Dye Division
- Age at study initiation (mean and range, SD): less than 24 hours

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

Test terminated after 48 hours.

Hardness:

136 mg/L CaCO3

Test temperature:

21 ± 1 °C

pH:

7.9 - 8.0

Dissolved oxygen:

Saturated

Salinity:

No data

Nominal and measured concentrations:

Nominal concentration: 50/ 100 and 180 mg test article/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 ml Glass beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 ml
- Aeration: No
- No. of organisms per vessel: 10 daphnids
- No. of vessels per concentration (replicates): Duplicate
- Biomass loading rate: 1 animal/10 ml

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Freshwater
- Ca/mg ratio: 4:1

OTHER TEST CONDITIONS
- Adjustment of pH: 7.8-8.2
- Photoperiod: 16hr light/ 8 hr dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Test concentrations: 58 I 100 and 180 mg/L nominal.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 184.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Calculation of EC values:
The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 101.7- 105.8 % of the nominal values. Therefore, under the test conditions the test article was sufficiently stable. In all test concentrations none alteration of the test substance after 48 h was observed. In the control and In all test concentrations no immobilization of the daphnids was observed after 48 h. Therefore, the EC50 values could not be calculated. The EC0 value is at least 184.2 mg/l, but might even be higher than this concentration. The EC50 and EC100 values are clearly higher than 184.2 mg/l.

Results with reference substance (positive control):

Potassium dichromate (EC50: 0.96 mg/l)

Reported statistics and error estimates:

None

Validity criteria fulfilled:

yes

Conclusions:

The EC50 and EC100 values are higher than 184.2 mg/l. Hence, FAT 92354/A is practically non toxic to Daphnia magna.

Executive summary:

An acute toxicity study with FAT 92354/A was carried out in a 48h static test using Daphnia magna according to the OECD 202 Guideline and EEC Directive 64/449, L 251, Part C.2. The test was performed in compliance with the Good Laboratory Practice Regulations. The nominal concentrations tested were 58, 100 and 180 mg test article/l, and a control without any additions. No immobility was observed during test duration in the control. The reported results are related to the analytical concentrations of the test article. During the test duration, the test article concentrations in the analysed test media were in the range of 101.7 - 105.8 % of the nominal values. Therefore, under test conditions, the test article was sufficiently stable. In all test concentrations, no alteration of the test substance after 46 h was observed. In all test concentrations, no immobilization of the daphnids was observed after 48 h. The EC₀ value is at least 184.2 mg/l, but might even be higher than this concentration. The EC₅₀ and EC₁₀₀ values are clearly higher than 184.2 mg/l. Therefore, the EC values could not be calculated.

Description of key information

The EC₀ value is at least 184.2 mg/l, but might even be higher than this concentration. The EC₅₀ and EC₁₀₀ values are clearly higher than 184.2 mg/l. Therefore, the EC values could not be calculated.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

184.2 mg/L

Additional information

An acute toxicity study with FAT 92354/A was carried out in a 48h static test using Daphnia magna according to the OECD 202 Guideline and EEC Directive 64/449, L 251, Part C.2. The test was performed in compliance with the Good Laboratory Practice Regulations. The nominal concentrations tested were 58, 100 and 180 mg test article/l, and a control without any additions. No immobility was observed during test duration in the control. The reported results are related to the analytical concentrations of the test article. During the test duration, the test article concentrations in the analysed test media were in the range of 101.7 - 105.8 % of the nominal values. Therefore, under test conditions, the test article was sufficiently stable. In all test concentrations, no alteration of the test substance after 46 h was observed. In all test concentrations, no immobilization of the daphnids was observed after 48 h. The EC₀ value is at least 184.2 mg/l, but might even be higher than this concentration. The EC₅₀ and EC₁₀₀ values are clearly higher than 184.2 mg/l. Therefore, the EC values could not be calculated.