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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
Limit test : 3 concentrations tested
Principles of method if other than guideline:
Guideline followed
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
None
Analytical monitoring:
yes
Details on sampling:
All test medium samples for the analytical determinations were taken after mixing of the test solutions from the approximate center of the test vessels and kept at -18 °C to -25 °C until analysis.
Vehicle:
no
Details on test solutions:
Stock solution:
1.0 g Test substance were mixed with 200 ml test medium and fill up to 1000 ml with test medium.
The stock solution was homogenized for five minutes in the supersonics bath.

Test concentrations:
Based on a pretest, the test concentrations were chosen as 58, 100 and 180 mg/l nominal.
Test organisms (species):
Daphnia magna
Details on test organisms:
The test organism was the species Daphnia magna. The daphnids were bred in the laboratories of the Textile Dyes Division, Product Ecology TF under standardized conditions. For the test, animals with age of less than 24 hours were used. The quality of the daphnids will be checked at least every 3 months by determining the EC50 values (24 h) for potassium dichromate (range: 0.8 -1.5 mg/l).
For each concentration, 20 daphnids were used.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
Study terminated after 48 h
Hardness:
136 mg/l CaCo3
Test temperature:
21 °C
pH:
7.8-8.2
Dissolved oxygen:
saturated
Salinity:
no data
Nominal and measured concentrations:
Nominal: 58, 100 and 180 mg/l
Details on test conditions:
The daphnids were exposed to the test article in 250 ml beakers containing 100 - 200 ml test medium with 10 animals per beaker.
All tests were performed in duplicate.
During exposure the animals were kept at 21 ± 1 °C with 16 hours illumination.
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
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 99.0 -100.7 % of the nominal values. Therefore under the test conditions the test article was sufficiently stable.

In the control and in the test concentrations up to 100 mg/l, no immobilization of the daphnids was observed after 48 hours. Therefore, the EC0 value is 100 mg/l. The EC50 and EC100 values are clearly higher than 179.4 mg/l.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
None

Table 1: Immobilisation of Daphnids

Nominal conc.

 (mg/l)

No. of Daphnids

No. of responses

% immobility

24 h

48 h

24 h

48 h

Blank

10

0

0

0

0

10

0

0

58

10

0

0

0

0

10

0

0

100

10

0

0

0

0

10

0

0

180

10

0

3

0

30

10

0

3

Validity criteria fulfilled:
yes
Conclusions:
The EC50 and EC100 values are higher than 180 mg/l (179.4 mg/l).
Executive summary:

The acute toxicity of FAT - 92348/A to Daphnia magna was determined in a 48-hour static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adapted 4 April 84, and EEC Directive 84/449, 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.

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 99.0 -100.7 % 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 48 h was observed.

In the control and in the test concentrations up to 100 mg/l no immobilization of the daphnids was observed after 48 hours. The EC0 value is 100.0 mg/l. At the test concentration 180 mg/l, 6 out of 20 Daphnids were immobilised. Hence, the EC50 and EC100 values are clearly higher than 180 mg/l.

Therefore, the EC50 could not be calculated.

Results :

EC0 >100.0 mg/l

EC50 >180 mg/l

EC100 >180 mg/l

Description of key information

The EC50 : > 180 mg/l was determined for FAT 92348/A.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
180 mg/L

Additional information

In the key study, the acute toxicity of FAT 92348/A to Daphnia magna was determined in a 48-hour static test according to the OECD Guideline and GLP. The nominal concentrations tested were 58, 100 and 180 mg test article/L, and a control without any additions. 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 99.0 -100.7 % 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 48 h was observed.

In the control and in the test concentrations up to 100 mg/l no immobilization of the daphnids was observed after 48 hours. The EC0 value is 100.0 mg/l. At the test concentration 180 mg/l, 6 out of 20 Daphnids were immobilised. Hence, the EC50 and EC100 values are clearly higher than 180 mg/l.

The test substance is also covered by the read-across of FAT 40007. Hence, data of this substance can be used to cover this endpoint.

Source substance FAT 40007/B was tested for its toxicity to Daphnia magna. The test was rperformed according to OECD test guideline 202 and in compliance with GLP principles. FAT 40007/B was tested for its toxicity to Daphnia magna in a 24 hr static test. The daphnia were exposed to the test substance in 50 ml beakers containing 20 ml test medium per 10 animals. During exposure, the animals were kept at 20 °C with 16-hrs of illumination. All tests were done in duplicates. Test concentrations were 62.5. 125, 250, 500 and 1000 mg/l. After 24 hrs the effect as immobility was observed and the effect concentration noted. The validity of the test was proven by determining the immobilization of the control animals tested under the same conditions. The immobility recorded with control, 62.5 and 125 mg/l concentrations was 0, 5 and 0%, respectively. Daphnids exposed to 250, 500 and 1000 mg/l test concentrations had 5, 40 and 100% immobility. Hence, using LOGIT analysis, following results were obtained:

EC0: 247.0 mg/L

EC50: 512.3 mg/L

EC100: 1062.7 mg/L

24 hr EC50 value calculated with LOGIT model with 95 % confidence limit is 500.3 mg/L.