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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Link to relevant study record(s)

Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 January 2012 to 2 February 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
yes
Remarks:
250 ml cell culture flasks were used. Test volume was 30 ml and the light intensity was at ~100-125 µE.m-2.s-1.
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
Deviations:
no
Principles of method if other than guideline:
Evaluation: These deviations were introduced to minimise any possible light shielding effect on algal growth as a consequence of the orange-red coloured test solutions.
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Identification: FAT 40854/A TE
Description: Reddish-brown powder (determined at NOTOX)
Batch: TZ 5719 / BOP 02-11
Content: 46.2 % (4 main constituents)
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 01 April 2016
Stability in water: Stability for at least 6 hours at room temperature
Solubility in water: More than 80 g/L
Analytical monitoring:
yes
Details on sampling:
During the final test singular samples for possible analysis were taken from all test concentrations and the control according to the schedule below. The method of analysis is described in the appended Analytical Report.

Frequency: at t=0 h and t=72 h
Volume: 3 ml
Storage: Samples were stored in a freezer until analysis.

At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling. Compliance with the Quality criteria regarding maintenance of actual concentrations was demonstrated by running a test vessel at the highest substance concentration but without algae and samples for analysis were taken at the start and at the end of the test period. Additionally, singular reserve samples of 3 ml were taken from all test solutions for possible analysis. If not already used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.
Vehicle:
no
Details on test solutions:
The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. Preparation of test solutions started with the highest concentration of 100 mg/l. No special treatment other than careful mixing was necessary to completely dissolve the test substance in test medium. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions ranged from clear and very slightly orange at 0.10 mg/l to clear red at 100 mg/l. After preparation, volumes of 30 ml were added to each replicate of the respective test concentration. Subsequently, 0.6 ml of an algal suspension was added to each replicate providing a cell density of 10E4 cells/ml.
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM

- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1.
- Source (laboratory, culture collection): In-house laboratory culture
- Age of inoculum (at test initiation): 3 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 10E4 cells/mL.
- Method of cultivation: Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light (60 to 120 µE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm in a climate room at a temperature of 21-24 °C).
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Hardness:
0.24 mmol (24 mg CaCO3/L)
Test temperature:
The temperature of the test medium was 22.0 °C at the start of the test. During the exposure period the temperature measured in the incubator was maintained between 22.5 and 23.4 °C.
pH:
Between 7.8 and 8.1
Nominal and measured concentrations:
Nominal concentrations tested were 0, 10, 18, 32, 56 and 100 mg/L. Analyses showed that measured concentrations were in agreement with nominal at the start of the test (103-106 %). Concentrations did not decrease during the test period.
Details on test conditions:
FINAL STUDY:
TEST SYSTEM
- Type: open
- Material, size, headspace, fill volume: 250 mL, cell culture flasks, containing 30 mL of test solution
- Aeration: no
- Initial cells density: 10000 cells/mL
- Control end cells density: 5260000 cells/mL
Replicates:
6 replicates of the control
3 replicates of each lower test concentration
1 or 2 replicates of each concentration without algae

GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: Continuously using TLD-lamps of the type ‘Cool-white’ of 30 Watt, with a light intensity within the range of 102 to 119 µE.m-2.s-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
72 h NOErC, 72 h NOEyC, 72 h ErC50, 72 h EyC50

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: control and 10, 18, 32, 56 and 100 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate (K2Cr2O7)
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: Nominal test substance concentrations were analytically confirmed.
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: Nominal test substance concentrations were analytically confirmed.
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: Nominal test substance concentrations were analytically confirmed.
Results with reference substance (positive control):
The EC50 for growth rate reduction (ERC50: 0-72h) was 1.8 mg/L with a 95 % confidence interval ranging from 1.4 to 2.4 mg/L.
The EC50 for yield inhibition (EYC50: 0-72h) was 0.69 mg/L with a 95 % confidence interval ranging from 0.50 to 0.95 mg/L.
Reported statistics and error estimates:
For determination of the NOEC and the EC50 the approaches recommended in the OECD guideline 201 were used. An effect was considered to be significant if statistical analysis of the data obtained for the test concentrations compared with those obtained in the negative control revealed significant reduction of growth rate or inhibition of yield (ANOVA, Bonferroni t-test, TOXSTAT Release 3.5, 1996, D.D. Gulley, A.M. Boelter, H.L. Bergman). Additionally, the EC10 was determined to meet the recommendations as put down in "A Review of Statistical Data Analysis and Experimental Design in OECD Aquatic Toxicology Test Guidelines" by S. Pack, August 1993.
Calculation of the EC10 values was based on log-linear regression analysis of the percentages of growth rate reduction and the percentages of yield inhibition versus the logarithms of the corresponding nominal concentrations of the test substance. No EC50-values could be calculated (EC50 > maximum concentration tested). In addition, no statistical analysis was performed on growth rate data as the effect was not biologically significant (<10 %).
Validity criteria fulfilled:
yes
Conclusions:
The EC50 for both growth rate reduction (ErC50: 0-72h) exceeded an analytically confirmed nominal concentration of 100 mg/L. The NOEC for growth rate reduction was 100 mg/L.
Executive summary:

In a GLP-compliant study, the toxicity of FAT 40854/A to the freshwater algae species Pseudokirchneriella subcapitata was determined according to EU method C.3 and OECD 201. The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. A final test was performed based on the results of a preceding combined limit/range-finding test. Six replicates of exponentially growing algal cultures were exposed to a control, whereas three replicates per test group were exposed to nominal FAT 40854/A concentrations of 10, 18, 32, 56 and 100 mg/l. The total test period was 72 hours and the initial algal cell density was 10E4 cells/ml. Samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period. Analyses showed that measured concentrations were in agreement with nominal at the start of the test (103-106 %). Concentrations did not decrease during the test period. The study met the acceptability criteria prescribed by the protocol and was considered valid. FAT 40854/A  did not significantly reduce growth rate of the fresh water algae species Pseudokirchneriella subcapitata at any of the concentrations tested. The EC50 for both growth rate reduction (ERC50: 0-72h) and yield inhibition (EYC50: 0-72h) exceeded an analytically confirmed nominal concentration of 100 mg/l. The NOEC for growth rate reduction was 100 mg/l. The NOEC for yield inhibition was 18 mg/l based on analytically confirmed nominal concentrations.

Description of key information

The EC50 for both growth rate reduction (ERC50: 0-72h) and yield inhibition (EYC50: 0-72h) exceeded an analytically confirmed nominal concentration of 100 mg/l. The NOEC for growth rate reduction was 100 mg/l. The NOEC for yield inhibition was 18 mg/l based on analytically confirmed nominal concentrations.

Key value for chemical safety assessment

EC50 for freshwater algae:
100 mg/L
EC10 or NOEC for freshwater algae:
100 mg/L

Additional information

In a GLP-compliant study, the toxicity of FAT 40854/A to the freshwater algae species Pseudokirchneriella subcapitata was determined according to EU method C.3 and OECD 201.The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. A final test was performed based on the results of a preceding combined limit/range-finding test. Six replicates of exponentially growing algal cultures were exposed to a control, whereas three replicates per test group were exposed to nominal FAT 40854/A concentrations of 10, 18, 32, 56 and 100 mg/l. The total test period was 72 hours and the initial algal cell density was 10cells/ml. Samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period. Analyses showed that measured concentrations were in agreement with nominal at the start of the test (103-106 %). Concentrations did not decrease during the test period. The study met the acceptability criteria prescribed by the protocol and was considered valid. FAT 40854/A did not significantly reduce growth rate of the fresh water algae species Pseudokirchneriella subcapitata at any of the concentrations tested. The EC50 for both growth rate reduction (ERC50: 0-72h) and yield inhibition (EYC50: 0-72 h) exceeded an analytically confirmed nominal concentration of 100 mg/l. The NOEC for growth rate reduction was 100 mg/l. The NOEC for yield inhibition was 18 mg/l based on analytically confirmed nominal concentrations.