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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Year: 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
GLP compliance:
yes
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Test type:
not specified
Water media type:
freshwater
Total exposure duration:
72 h
Reference substance (positive control):
not specified
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
ca. 22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
ca. 4.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
9.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: area under growth curve
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
2.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: area under growth curve
Validity criteria fulfilled:
yes
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
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:
1. SOFTWARE
not specififed
2. MODEL (incl. version number)
ECOSAR
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
CAS 93-15-2
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
[Explain how the model fulfils the OECD principles for (Q)SAR model validation. Consider attaching the QMRF or providing a link]
- Defined endpoint: Acute 96-h algae growth inhibition
- Unambiguous algorithm: not specified
- Defined domain of applicability: not specified
- Appropriate measures of goodness-of-fit and robustness and predictivity: not specified
- Mechanistic interpretation: not specified
Qualifier:
no guideline required
Principles of method if other than guideline:
- Software tool(s) used including version: not specified
- Model(s) used: ECOSAR
- Model description: see field 'Justification for non-standard information', 'Attached justification'
- Justification of QSAR prediction: see field 'Justification for type of information', 'Attached justification'
Analytical monitoring:
not required
Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Key result
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
8.3 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
growth rate
Validity criteria fulfilled:
yes
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
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 limited documentation / justification
Justification for type of information:
1. SOFTWARE
Danish QSAR database
2. MODEL (incl. version number)
2017
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
c1(OC)c(OC)cc(CC=C)cc1
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
[Explain how the model fulfils the OECD principles for (Q)SAR model validation. Consider attaching the QMRF or providing a link]
- Defined endpoint: not specified
- Unambiguous algorithm: not specified
- Defined domain of applicability: not specified
- Appropriate measures of goodness-of-fit and robustness and predictivity: not specified
- Mechanistic interpretation: not specified

5. APPLICABILITY DOMAIN
[Explain how the substance falls within the applicability domain of the model]
- Descriptor domain: not specified
- Structural and mechanistic domains: not specifed
- Similarity with analogues in the training set: not specifed
- Other considerations (as appropriate): not specified

6. ADEQUACY OF THE RESULT
[Explain how the prediction fits the purpose of classification and labelling and/or risk assessment]
The results from the Danish QSAR database supports the risk characterization and classification and labelling that was demonstrated by the experimental results.
Qualifier:
no guideline available
Principles of method if other than guideline:
- Software tool(s) used including version: Danish QSAR database
- Model(s) used: 2017
- Model description: see field 'Justification for non-standard information', 'Attached justification'
- Justification of QSAR prediction: see field 'Justification for type of information', 'Attached justification'
Key result
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
11.972 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
growth rate
Validity criteria fulfilled:
yes

Description of key information

A study with the registered substance following the OECD guidance 201 and GLP was performed by the Ministry of Environment in Japan. The EC50 after 72h of exposure was found to be 22 mg/L while the NOEC was 4.6 mg/L. Furthermore a QSAR analysis by the Canadian authorities shows similar results with the 96h EC50, using ECOSAR models, is found to be 8.30 mg/L. Ultimately the Danish QSAR database showed similar results with values of 11.972 mg/L for the 96h EC50.

Key value for chemical safety assessment

EC50 for freshwater algae:
22 mg/L
EC10 or NOEC for freshwater algae:
4.6 mg/L

Additional information