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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
72 hours
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guidelines study to GLP, with chemical analysis to verify concentrations
according to guideline
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Date 07 Mar 16;
Physical Description: Clear liquidStorage Conditions:
Room temperaturePurity: 41% active ingredient per Sponsor informationStability: Not provided to testing facility
Analytical monitoring:
Details on sampling:
Dose verification was performed during the study on test solutions sampled at 0 and 72 hours for the definitive test.
Details on test solutions:
The definitive stock solution was prepared by dissolving 0.003 g of test item in 1000 mL of OECD medium and mixing for approximately 15 minutes. This stock solution was diluted with dilution water to make five different test item solutions with five different concentrations for the definitive test. A test item control solution was made using only dilution water.
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
STILLMEADOW, Inc. cultures
Age: Mass culture initiated 3-7 ± 1 days prior to dosing
Density: Initial cell density was 50,000 cells/mL
Test type:
Water media type:
Limit test:
Total exposure duration:
72 h
Not specificed
Test temperature:
Temperature of 24 ±2°C
Autoclaved media was a pH of 8.1
Dissolved oxygen:
Not specified
Nominal and measured concentrations:
The five concentrations of the test item used in the definitive test were Nominsal 0.03125 mg a.i./L, 0.0625 mg a.i./L, 0.125 mg a.i./L, 0.25 mg a.i./L and 0.5 mg a.i./L.
Reference substance (positive control):
Zinc chloride at 10 mg/l
72 h
Dose descriptor:
Effect conc.:
ca. 0.19 mg/L
Nominal / measured:
Conc. based on:
act. ingr.
Basis for effect:
cell number
Key result
72 h
Dose descriptor:
Effect conc.:
ca. 0.37 mg/L
Nominal / measured:
Conc. based on:
act. ingr.
Basis for effect:
growth rate
72 h
Dose descriptor:
Effect conc.:
ca. 0.125 mg/L
Nominal / measured:
Conc. based on:
act. ingr.
Basis for effect:
cell number
Details on results:
The results are based on nominal concentrations.
Analysis of the test media failed to detect the substance at the end of the study period.
Results with reference substance (positive control):
Reported statistics and error estimates:
Good statistical reliability
The NOEC and EC50 were determined by a commercially available statistical program (ToxCalc Version 5.0™). Linear Interpolation was used for EC50 determination
Validity criteria fulfilled:
At 72 hours, the growth rate EC50 was determined to be 0.37 mg a.i./L with 95% confidence limits of 0.22-0.45 mg a.i./L

At 72 hours, the test concentration of ColaLipid C that resulted in cell density Median Effective Concentration (EC50) was determined to be 0.19 mg a.i./L with 95% confidence limits of 0.10-0.25 mg a.i./L

At 72 hours, the cell density No Observed Effect Concentration (NOEC) was determined to be 0.125 mg a.i./L .
Executive summary:

Even though chemcial analysis failed to detect the test material at the end of the study, this is not unusual for highly biodegradable materials tested at very low concentrations. In view of the known stability of the test material in water, it is considered that the nominal concentrations canbe used for estimating the EC50.

Confirmatory analysis suggested higher concentrations than nominal at the start of exposure, but these were not used for estimating the EC50 or NOAEC.

The Growth Rate EC50 is used for classification and is considered the key result.

Description of key information

Key value for chemical safety assessment

EC50 for freshwater algae:
0.37 mg/L

Additional information