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Long-term toxicity to fish

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Endpoint:
adult fish: sub(lethal) effects
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
The substance falls within the applicability domain of the selected (Q)SAR method.
Qualifier:
according to guideline
Guideline:
other: EPI SUITE ECOSAR v 1.0 and 1.11
GLP compliance:
no
Test organisms (species):
other: freshwater fish (unspecified species)
Test type:
other: Chronic 30 d QSAR
Water media type:
freshwater
Total exposure duration:
30 d
Key result
Duration:
30 d
Dose descriptor:
other: ChV (chronic value)
Effect conc.:
0.563 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
other: not specified in the QSAR
Key result
Duration:
30 d
Dose descriptor:
NOEC
Effect conc.:
0.398 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
other: not specified in the QSAR
Details on results:
The estimated toxicity to a freshwater fish species using the US EPA ECOSAR model was 0.563 mg/L (ChV). According to ECHA REACH Guidance R.10, if in the test report only the ChV is presented, this value can be divided by √2 to derive a NOEC. 0.563 mg/L was divided by root 2 to give a NOEC value of 0.398 mg/L.
Validity criteria fulfilled:
not applicable
Conclusions:
Under the study conditions, 30 d NOEC for freshwater fish was considered to be 0.398 mg/L.
Executive summary:

A study was conducted to determine the chronic toxicity of the test substance to freshwater fish using the EPI SUITE ECOSAR v 1.0 and 1.11 model. The estimated 30 d ChV (chronic value) was 0.563 mg/L. The ChV corresponds to the geometric mean of the NOEC and LOEC. Thus, according to ECHA REACH Guidance R.10, the ChV can be divided by √2 to derive a NOEC. In this case 0.563 mg/L was divided by root 2 to yield a NOEC value of 0.398 mg/L. Under the study conditions, 30 d NOEC for freshwater fish was therefore considered to be 0.398 mg/L (US EPA, 2017).

Endpoint:
adult fish: sub(lethal) effects
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
The substance falls within the applicability domain of the selected (Q)SAR method.
Qualifier:
according to guideline
Guideline:
other: EPI SUITE ECOSAR v 1.0 and 1.11
GLP compliance:
no
Test organisms (species):
other: Saltwater fish (species unspecified)
Test type:
other: chronic toxicity study (assume 30 d)
Water media type:
saltwater
Total exposure duration:
30 d
Key result
Duration:
30 d
Dose descriptor:
other: ChV
Effect conc.:
1.636 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Basis for effect:
other: QSAR
Key result
Duration:
30 d
Dose descriptor:
NOEC
Effect conc.:
1.16 mg/L
Nominal / measured:
not specified
Conc. based on:
act. ingr.
Details on results:
The estimated toxicity to a salt water fish species using the EPA ECOSAR model is 1.636 mg/L (ChV). According to ECHA REACH Guidance R.10, if in the test report only the ChV is presented, the ChV can be divided by √2 to derive a NOEC. 1.636 mg/L was divided by root 2 to give a NOEC value of 1.160 mg/L.
Validity criteria fulfilled:
not applicable
Conclusions:
Under the study conditions, the 30 d NOEC for marine fish was considered to be 1.160 mg/L.
Executive summary:

A study was conducted to determine the chronic toxicity of the test substance to marine fish using the EPI SUITE ECOSAR v 1.0 and 1.11 model. The ChV corresponds to the geometric mean of the NOEC and LOEC. Thus, according to ECHA REACH Guidance R.10, the ChV can be divided by √2 to derive a NOEC. In this case 1.636 mg/L was divided by root 2 to give a NOEC value of 1.160 mg/L. Under the study conditions, the 30 d NOEC for marine fish was therefore considered to be 1.160 mg/L (US EPA, 2017).

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.398 mg/L

Marine water fish

Marine water fish
Effect concentration:
1.16 mg/L

Additional information

Freshwater fish

A study was conducted to determine the chronic toxicity of the test substance to freshwater fish using the EPI SUITE ECOSAR v 1.0 and 1.11 model. The estimated 30 d ChV (chronic value) was 0.563 mg/L. The ChV corresponds to the geometric mean of the NOEC and LOEC. Thus, according to ECHA REACH Guidance R.10, the ChV can be divided by √2 to derive a NOEC. In this case 0.563 mg/L was divided by root 2 to yield a NOEC value of 0.398 mg/L. Under the study conditions, 30 d NOEC for freshwater fish was therefore considered to be 0.398 mg/L (US EPA, 2017).

Marine fish

A study was conducted to determine the chronic toxicity of the test substance to marine fish using the EPI SUITE ECOSAR v 1.0 and 1.11 model. The ChV corresponds to the geometric mean of the NOEC and LOEC. Thus, according to ECHA REACH Guidance R.10, the ChV can be divided by √2 to derive a NOEC. In this case 1.636 mg/L was divided by root 2 to give a NOEC value of 1.160 mg/L. Under the study conditions, the 30 d NOEC for marine fish was therefore considered to be 1.160 mg/L (US EPA, 2017).