Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
07/03/2018-08/03/2018
Reliability:
1 (reliable without restriction)
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
Guideline:
other: REACH Guidance on QSARs R.6 (following OCDE 202)
GLP compliance:
no
Specific details on test material used for the study:
Constituent citric acid : OC(=O)CC(O)(CC(=O)O)C(=O)O
Analytical monitoring:
not required
Details on sampling:
Not applicable
Vehicle:
not specified
Details on test solutions:
Not applicable
Test organisms (species):
Daphnia sp.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.22 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: QSAR predicted value
Reported statistics and error estimates:
95% confidence limits (g test item.L-1) : 0.14 – 0.33

The MODEL used predicted that citric acid has a EC50 value of 0.22 g item /L on daphnids.

Validity criteria fulfilled:
not applicable
Executive summary:

The toxicity to daphnids of citric acid is : 0.22 g/L

Based on a constituent approach, the acute toxicity to daphnids of EXTRACT OF ALLIUM CEPA (AMARYLLIDACEAE) BULB AND CITRUS LIMON (RUTACEAE) PULP AND SODIUM CHLORIDE is considered as greater than 100 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
07/03/2018-08/03/2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
Guideline:
other: REACH Guidance on QSARs R.6 (following OCDE 202)
GLP compliance:
no
Specific details on test material used for the study:
Constituent glucose Smile : C([C@@H]1[C@H]([C@@H]([C@H](C(O1)O)O)O)O)O
Analytical monitoring:
not required
Details on sampling:
Not applicable
Vehicle:
not specified
Details on test solutions:
Not applicable
Test organisms (species):
Daphnia sp.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 26 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: QSAR predicted value
Reported statistics and error estimates:
95% confidence limits (g test item.L-1) : 23 - 28

The MODEL used predicted that glucose has a EC50 value of 26 g item /L on daphnids.

Validity criteria fulfilled:
not applicable
Executive summary:

The toxicity to daphnids of glucose is : 26 g/L

Based on a constituent approach, the acute toxicity to daphnids of EXTRACT OF ALLIUM CEPA (AMARYLLIDACEAE) BULB AND CITRUS LIMON (RUTACEAE) PULP AND SODIUM CHLORIDE is considered as greater than 100 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
07/03/2018-08/03/2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
Guideline:
other: REACH Guidance on QSARs R.6 (following OCDE 202)
GLP compliance:
no
Specific details on test material used for the study:
Constituent sucrose Smile : C([C@@H]1[C@H]([C@@H]([C@H]([C@H](O1)O[C@]2([C@H]([C@@H]([C@H](O2)CO)O)O)CO)O)O)O)O
Analytical monitoring:
not required
Details on sampling:
Not applicable
Vehicle:
not specified
Details on test solutions:
Not applicable
Test organisms (species):
Daphnia sp.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 180 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: QSAR predicted value
Reported statistics and error estimates:
95% confidence limits (g test item.L-1) : 164 – 198

The MODEL used predicted that sucrose has a EC50 value of 180 g item /L on daphnids.

Validity criteria fulfilled:
not applicable
Executive summary:

The toxicity to daphnids of sucrose is : 180 g/L

Based on a constituent approach, the acute toxicity to daphnids of EXTRACT OF ALLIUM CEPA (AMARYLLIDACEAE) BULB AND CITRUS LIMON (RUTACEAE) PULP AND SODIUM CHLORIDE is considered as greater than 100 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Results from : Khangarot BS, Ray PK; Ecotoxicol Environ Saf 18 (2): 109-120 (1989) Available from, as of November 21, 2006:http://cfpub.epa.gov/ecotox/quick_query.htm
GLP compliance:
no
Specific details on test material used for the study:
Constituent sodium chloride : [Na+].[Cl-]
Analytical monitoring:
not required
Vehicle:
not specified
Test organisms (species):
Daphnia sp.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.403 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Reported statistics and error estimates:
95% confidence limits (g test item.L-1) : 0.3407 – 0.4692
Validity criteria fulfilled:
not applicable
Executive summary:

The toxicity to daphnids of sodium chloride is : 0.4026 g/L

Based on a constituent approach, the acute toxicity to daphnids of EXTRACT OF ALLIUM CEPA (AMARYLLIDACEAE) BULB AND CITRUS LIMON (RUTACEAE) PULP AND SODIUM CHLORIDE is considered as greater than 100 mg/L.

Description of key information

The immobility of the daphnids was determined using validated QSAR models for the Mechanisms of Action (MechoA) associated to the constituents, i.e. MechoA 1.1: baseline toxicity (non-polar narcosis) and MechoA 5.2: carboxylic acids. The QSAR models used are based on validated data derived from 48-hour test on daphnids, for which the concentrations of the test item had been determined by chemical analyses over the test period.

Based on a constituent approach, the acute toxicity to daphnids of EXTRACT OF ALLIUM CEPA (AMARYLLIDACEAE) BULB AND CITRUS LIMON (RUTACEAE) PULP AND SODIUM CHLORIDE is considered as greater than 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information