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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
other information
Study period:
February 01,2007 to October 07,2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
- The OECD Principles of Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17 - Chemikaliengesetz (, Chemicals Act 7 der Bundesrepublik Deutschland (ChemG), Anhang 1 (,Annex I 7, 2002 - Directive 2004/1 O/EC of 11 February 2004 (Official Journal No. L 50/44)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
2 1 15 15-46-7
IUPAC Name:
2 1 15 15-46-7
Details on test material:
Name: CAT - Acid chloride
CAS No.: 2 1 15 15-46-7
Certificate of Analysis Date: March 30,2006
Type: Active ingredient of a pharmaceutical
Aggregate State at Room Temperature: Liquid (according to IBACON personnel)
Colour: Brown (according to BACON personnel)
Stability : Technical product:
Expiry Date: July 03,2007
Storage: In original container, in the refrigerator (2-8 degree C), in the dark.

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
24 and 48 exposure durations

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
11 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
3.3 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
2.2 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
4.5 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
19.4 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC10
Effect conc.:
7.2 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
10.4 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
LOEC
Effect conc.:
21.4 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

Results:

After 48 hours of exposure no immobilization of the test animals was observed in the control and the test item concentration of 2.2 mg/l mean measured. At the concentration of 4.5 mg/l mean measured six animals were immobile and all 20 animals were immobile at the concentration of 53 mg/l mean measured (filtrate).

 

Analytical Method:

The test item was analysed using a TOC method.

 

Analytical Results:

At the start of the test 44% of the nominal test concentration

was found (mean value of the two highest test concentrations).

This calculation based on nominal test concentrations not

considering the fact that the test media were filtrated to remove

the non-dissolved part of the test item. Therefore, these reduced

findings are not surprising. In the aged test media 56% of the

nominal value was determined (mean value of the two highest

test concentrations). Thus, during the test period the daphnia

were exposed to a mean of 50% of nominal (mean value of the

two highest test concentrations). Therefore, the results of the

two highest concentrations (filtrate and one dilution) are

expressed in terms of mean measured concentrations of the test

item. For the three lowest concentrations under the limit of

quantification the concentration was calculated by multiplying

the nominal value with the overall mean recovery from the two

highest concentrations (50%).

TOC analysis cannot differ between test item and degradation

products (both of them contribute to the signal, which is

evaluated). However, for the calculation of the recovery rate

this has not to be considered.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Conclusion:
The toxic effect of the test item CAT - Acid chloride to
Daphnia magna was assessed in a static dose-response test. The
48-hour EC50 value was 11.0 mg test item/l.
Executive summary:

Title:

Acute Toxicity of CAT - Acid chloride to Daphnia magna in a Static 48-

hour Immobilization Test

 

Guidelines:

- Commission Directive 92/69/EEC, Annex Part C, C.2: "Acute Toxicity

for Daphnia",Official Journal of the European Communities No.

L 383 A, dated December 29, 1992

- OECD Guideline for Testing of Chemicals 202:"Daphnia sp., Acute

Immobilisation Test" adopted April 13,2004.

 

Material and methods:

Test Item:

CAT - Acid chloride

 

Test Species:

Female Daphnia magna,clone 5; 6.5 to 22.5 hours old, source: ECT

Oekotoxikologie GmbH, Böttgerstr. 2 - 14, 65439 Flörsheim am Main,

Germany.

 

Test Design:

This study encompassed 6 treatment groups (a filtrate of the test item and 4

dilutions as well as a control) each containing 20 individuals. The

immobility of the Daphnia was determined in a static 48-hour test by visual

controls after 24 and 48 hours.

Since the test item is instable and insoluble in test water, it was tested

according to OECD No. 23 (Testing of Difficult Substances). Therefore, the

stock solution was stirred for 24 hours, in order to make allowance for the

water insolubility of the test item. The non-dissolved part of the test item

was afterwards removed by filtration. Due to the instability of the test item,

mainly the degradation products were tested.

The purpose of the analytical part of this study was to measure the dissolved

part of the test item and/or its degradation products using measurement of

Total Organic Carbon (TOC) as sum parameter.

 

Endpoints:

Number of immobile organisms after 48 hours.

 

Test Rates:

Control, filtrate of nominal 100 mg test item, the dilutions 1:2.2, 1:4.8,

1:11, 1:23 of this filtrate (corresponding to mean measured values of 53,

21.4, 10.4, 4.5 and 2.2 mg/l). The test media were prepared just before

introduction of daphnia (= start of the test).

 

Test Conditions:

Water temperature: 19 degree C - 2O degree C; photoperiod: 16 h light - 8 h dark; light

intensity: 58 - 146 lux; dissolved oxygen concentration: 6.9 to 8.6 mg/l; pH

value: 6.7 to 7.6; and thus were within the ranges requested by guideline

OECD 202

 

Results:

After 48 hours of exposure no immobilization of the test animals was observed in the control and the test

item concentration of 2.2 mg/l mean measured. At the concentration of 4.5 mg/l mean measured six

animals were immobile and all 20 animals were immobile at the concentration of 53 mg/l mean measured (filtrate).

 

Analytical Method:

The test item was analysed using a TOC method.

 

Analytical Results:

At the start of the test 44% of the nominal test concentration

was found (mean value of the two highest test concentrations).

This calculation based on nominal test concentrations not

considering the fact that the test media were filtrated to remove

the non-dissolved part of the test item. Therefore, these reduced

findings are not surprising. In the aged test media 56% of the

nominal value was determined (mean value of the two highest

test concentrations). Thus, during the test period the daphnia

were exposed to a mean of 50% of nominal (mean value of the

two highest test concentrations). Therefore, the results of the

two highest concentrations (filtrate and one dilution) are

expressed in terms of mean measured concentrations of the test

item. For the three lowest concentrations under the limit of

quantification the concentration was calculated by multiplying

the nominal value with the overall mean recovery from the two

highest concentrations (50%).

TOC analysis cannot differ between test item and degradation

products (both of them contribute to the signal, which is

evaluated). However, for the calculation of the recovery rate

this has not to be considered.

 

Conclusion:

The toxic effect of the test item CAT - Acid chloride to

Daphnia magna was assessed in a static dose-response test. The

48-hour EC50 value was 11.0 mg test item/l.