Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From December 6th to 08th, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines and performed according to GLP. Justification for Read Across is detailed in the endpoint summary.
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Analysis of the test concentration plus a control was performed at test start and after 48 hours of exposure.
Vehicle:
no
Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: stock solution, magnetic stirrer.
The substance was seen to solvate completely at a concentration of 100 mg/l.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Species: Daphnia magna Straus, parthenogenetic females.
- Origin of species: cloned at the Federal Health Office (EGA) in Berlin.
- Source: Laboratory bred at Bayer AG Leverkusen.
- Age of test animal: 0-24 hours.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
None
Hardness:
12.9
Test temperature:
20.8 °C
pH:
8
Dissolved oxygen:
8.7
Nominal and measured concentrations:
100 mg/l nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: cylindrical test vessel.
- Test volume: 20 ml
- Material, size, headspace, fill volume: diameter 4.0cm, height 6.5cm.
- Aeration: not ventilated.
- No. parallel solutions: 2
- No. daphnids per vessel: 10
- Operating conditions: static system in accordance with study method.

TEST MEDIUM / WATER PARAMETERS
- Method of administration: stock solution (120 mg/l).
- Medium: M4-Medium according to Elendt and BGA (1992).
- Water for dilution: M4-Medium according to Elendt and BGA (1992).
- Water hardness [°dH]: 12.9 (M4-Medium).

EFFECT PARAMETERS MEASURED
Number of immobile daphnids after 24 hours and 48 hours.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 70 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No deaths occurred.

The analytical content of the test item resulted to be lower than 80 % of the nominal value; the decrease of test item concentration is due to the fact that the test substance hydrolyses easily from the ester and vinyl structure to the alcohol of the dyestuff.

Nominal Concentration test substance (mg/l) Results after 24 and 48 hours
Immobile Daphnids Oxygen, mg/l – 48 h pH – 48 h Temperature (°C) – 48 h
Absolute %
24 48 24 48
Control 0 1 0 5 8.6 8 21.0
100 0 0 0 0 8.7 8 20.8

 

Nominal Concentration test substance (mg/l) Results by start of test and after 48 hours [mg/l]
0 hours 48 hours
control < 2 < 2
100 27 29

after 24 hours after 48 hours
nominal concentration of test substance arithmetic mean of analytical values
EC0 > 100 mg/l EC0 ≥ 70  mg/l test substance
 EC0 ≥ 28  mg/l TOC

Comments relevant to result: to produce the test solution, the test substance was weighed into water and stirred with a magnetic stirrer for 1 hour.

Conclusions:
EC50 (48h) >70 mg/l (meas. arithm. mean)
Executive summary:

A study to evaluate the potential toxicity of the test substance to daphnids was conducted according to EU test guidance 67/548/EEC part C2 and in compliance with GLP.

The EC0 of the test substance after 48 hours was equal/higher than 100 mg/l nominally (i.e. 70 mg/l as mean of the analytical determined values). 

The analytical content of the test item resulted to be lower than 80 % of the nominal value; the decrease of test item concentration is due to the fact that the test substance hydrolyses easily from the ester and vinyl structure to the alcohol of the dyestuff.

Due to the fact that the EC0 is equal/higher than 70 mg/l without any adverse effects on the daphnids, it can be concluded that the EC50 of the test substance is higher than 100 mg/l.

 

Conclusion

EC50 (48h) >70 mg/l (meas. arithm. mean)

Description of key information

Not expected to be harmful to Daphnia

Key value for chemical safety assessment

Additional information