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EC number: 604-617-1 | CAS number: 147993-66-6
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2014
- Justification for type of information:
- The read across is justified by the similar structure and C-chain-length of the registered target substance when compared to the read across source substance. Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Remarks on result:
- other:
- Remarks:
- Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance.
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Remarks on result:
- other:
- Remarks:
- Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance.
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 0.44 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth
- Remarks on result:
- other: No adverse effect observed
- Remarks:
- Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance.
- Details on results:
- The read across is justified by the similar structure and C-chain-length of the registered target substance when compared to the read across source substance. Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance.
- Validity criteria fulfilled:
- yes
- Conclusions:
- 21-day EC10: 0.22 mg/L
- Executive summary:
In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of the read across source substance Sulfosuccinic (FA C12-18)E, 2Na on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /L and a blank control. Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 10, 60 and 100% mortality was observed in the control and at nominal test concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /L, respectively.
The reproduction per parent daphina was 124.6 (10), 145.6 (10), 126.9 (10), 131.7 (10), 127.0 (10), and 98.6 (10) living offspring per parental animal (number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.1375, 0.275, 0.55, 1.1 and 2.2 mg/L, respectively.
In the biologically relevant dose groups, the measured test item concentrations in the freshly prepared test media of the nominal concentrations of 0.55 to 2.2 mg/L were between 89 and 112% of the nominal values at the start of the test medium renewal periods. In the aged test media samples without food, the measured concentrations as % nominal were between 83 and 104%. Therefore, the biological results were based on nominal concentrations.
The EC10 for mortality is 1.1 mg/L, the EC10 for reproduction is 1.6 mg/L. Length was not affected. For the risk assessment, the more conservative EC10, i.e., the EC10 for mortality was used.
The read across is justified by the similar structure and C-chain-length of the registered target substance when compared to the read across source substance. Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance, i.e., the overall EC10 is 0.22 mg/L for the target substance.
The result is considered relevant and reliable for the risk assessment.
Reference
Description of key information
21-day EC10: 0.22 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.22 mg/L
Additional information
In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of the read across source substance Sulfosuccinic (FA C12-18)E, 2Na on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /L and a blank control. Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 10, 60 and 100% mortality was observed in the control and at nominal test concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /L, respectively.
The reproduction per parent daphina was 124.6 (10), 145.6 (10), 126.9 (10), 131.7 (10), 127.0 (10), and 98.6 (10) living offspring per parental animal (number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.1375, 0.275, 0.55, 1.1 and 2.2 mg/L, respectively.
In the biologically relevant dose groups, the measured test item concentrations in the freshly prepared test media of the nominal concentrations of 0.55 to 2.2 mg/L were between 89 and 112% of the nominal values at the start of the test medium renewal periods. In the aged test media samples without food, the measured concentrations as % nominal were between 83 and 104%. Therefore, the biological results were based on nominal concentrations.
The EC10 for mortality is 1.1 mg/L, the EC10 for reproduction is 1.6 mg/L. Length was not affected. For the risk assessment, the more conservative EC10, i.e., the EC10 for mortality was used.
The read across is justified by the similar structure and C-chain-length of the registered target substance when compared to the read across source substance. Since the read across source substance had a 5 times lower ecotoxicity when compared to the target substance, this factor was considered when calculating the effect concentrations for the target substance, i.e., the overall EC10 is 0.22 mg/L for the target substance.
The result is considered relevant and reliable for the risk assessment.
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