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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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental data of various test chemical
Justification for type of information:
Data for the test chemical is summarized based data from various test chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
WoE derived based on the experimental data from various test chemicals
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
study 2: Preparation of the stock solution and dilution: The test substance was stirred in M4-medium for about 20 hours. Undisolved test substance was removed by centrifugation (approx. 20 min about 17700 G). The result is a clear solution.
The study was performed with an aqueous extract (eluate) of the test substance.
Test organisms (species):
Daphnia magna
Details on test organisms:
2: Daphnia magna STRAUS
3: - Common name: Water flea
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Remarks on exposure duration:
24 hrs in 3rd study
Nominal and measured concentrations:
2: Test concentrations : 100 mg/L; 10 mg/L; 1 mg/L; 0.1 mg/L; 0.01 mg/L
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
10.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 2nd study
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 3rd study

study 2nd:

Concentration Effect Relationship After 48 hrs :

Nominal Concentration ( mg/L)

Number of daphnia without inhibition (from 20)

Inhibition (%)

0 (control)

20

0

100

0

100

10

12

40

1

20

0

0.1

20

0

0.001

20

0

 

Validity criteria fulfilled:
no
Conclusions:
2nd study: The EC-values of Pigment violet 27 in Daphnia magna, which cause after 48 h no (EC0) or 50% (EC50) and 100% (EC100) inhibition of the swimming ability compared to an untreated control are:
EC0* = 1 mg/L (nominal)
EC50 = 10.8 mg/L (nominal)
EC100 =100 mg/L (nominal)

3rd study: The effect concentration EC50 was observed to be 22 mg/l for test chemical on daphnia magba after 24h of exposure.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.
Executive summary:

Data available for the various test chemicals was reviewed to determine the toxicity of the test chemical on aquatic invertebrates. The studies are as mentioned below:

In the first key study from experimental report toxicity were determine. Determination of acute toxicity of the test substance according to EEC Directive 93/32/EEC (December 1992) to freshwater invertebrate Daphnia magna was done using different test sample. The acute effect on the swimming ability of water flea under the influence of various concentrations 100 mg/l, 10 mg/I, 1 mg/l, 0.1 mg/l, 0.01 mg/l of test substance was studied for 48 hours. The EC-values indicating the concentrations of the test substance, which cause after 48 h were calculated (EC0) or 50% (EC50) and 100% (EC100) inhibition of the swimming ability compared to an untreated control are:

EC0* = 1 mg/l (nominal)

EC50 = 10.8 mg/l (nominal)

EC100 =100 mg/l (nominal)

*highest test concentration with an effect of ≤ 10%.

Similar study was to evaluate the toxicity of test chemical on the biological activity and mobility of daphnia magna. Test conducted under the static system for 24 hrs. The effect concentration EC50 was observed to be 22 mg/l for chemical after 24h of exposure. Based on the EC50 value, chemical was consider as toxic and can be consider to be classified as aquatic chronic category 3 as per the CLP classification criteria.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Description of key information

2nd study: The EC-values of Pigment violet 27 in Daphnia magna, which cause after 48 h no (EC0) or 50% (EC50) and 100% (EC100) inhibition of the swimming ability compared to an untreated control are:

EC0* = 1 mg/L (nominal)

EC50 = 10.8 mg/L (nominal)

EC100 =100 mg/L (nominal)

3rd study: The effect concentration EC50 was observed to be 22 mg/l for test chemical on daphnia magba after 24h of exposure.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
10.8 mg/L

Additional information

Data available for the various test chemicals including for read across chemical selected on the basis of structurally and functionally similarity with the test chemical were reviewed to determine the toxicity of the test chemical on aquatic invertebrates. The studies are as mentioned below:

 

In the first key study from experimental report toxicity were determine. Determination of acute toxicity of the test substance according to EEC Directive 93/32/EEC (December 1992) to freshwater invertebrate Daphnia magna was done using different test sample. The acute effect on the swimming ability of water flea under the influence of various concentrations 100 mg/l, 10 mg/I, 1 mg/l, 0.1 mg/l, 0.01 mg/l of test substance was studied for 48 hours. The EC-values indicating the concentrations of the test substance, which cause after 48 h were calculated (EC0) or 50% (EC50) and 100% (EC100) inhibition of the swimming ability compared to an untreated control are:

EC0* = 1 mg/l (nominal)

EC50 = 10.8 mg/l (nominal)

EC100 =100 mg/l (nominal)

*highest test concentration with an effect of ≤ 10%.

 

Similar study was to evaluate the toxicity of test chemical on the biological activity and mobility of daphnia magna. Test conducted under the static system for 24 hrs. The effect concentration EC50 was observed to be 22 mg/l for chemical after 24h of exposure. Based on the EC50 value, chemical was consider as toxic and can be consider to be classified as aquatic chronic category 3 as per the CLP classification criteria.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.