Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 480-460-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Test article name : Amorphophallus campanulatus dry purified extract
Batch code : 29895/M1
Chemical class : Botanical extract
Preparation date : April, 2009
Expiry date : April, 2011
Physical form at 20°C : Powder
Colour : Pale brown
Storage conditions : The product was stored at room temperature, in well ventilated room, in its own original container
Safety precautions : Routinely hygienic procedures
Sampling and analysis
- Analytical monitoring:
- yes
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Study design
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- the ambient temperature under the lights was continuously measured by the mean of a data logger. It was in the range 22.9 – 25.0 °C.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 22.3 mg/L
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 67.64 mg/L
- Basis for effect:
- growth rate
Any other information on results incl. tables
A full test was performed in accordance with the OECD Guideline No. 201, 2006 to evaluate the effect of the test itemAmorphophallus campanulatusdry purified extract onPseudokirchneriella subcapitata.
Cell density was measured every 24 hours by fluorescent reading with a spectrofluorophotometer in few millilitre samples taken from each test concentration replicate, from controls and from the screened solution replicate. The obtained cell densities for each replicate are reported in Table 2 while, in Table 3, the effect due to the light absorption on the growth ofPseudokirkneriella subcapitatais shown.
Table 2 Effect ofAmorphophallus campanulatusdry purified extract on the growth ofPseudokirchneriella subcapitata
Nominal test concentration [mg/L] |
replicate |
Cell density (n. cells x 104/ml) |
|||||||||
0 h |
24 h |
48 h |
72 h |
||||||||
Negative control |
A B C D E F Average value |
1 1 1 1 1 1 1 |
4.4366 4.1781 4.7081 4.0745 5.2250 5.8142 4.7394 |
24.6571 23.1341 25.8591 20.5951 30.5911 26.7931 25.2716 |
108.5761 97.7271 100.4801 103.5571 96.2481 95.2161 100.3008 |
||||||
10.0 |
A B C Average value |
1 1 1 1 |
7.1843 6.8256 7.1586 7.0562 |
35.8485 32.6505 32.2175 33.5722 |
66.8259 74.6289 73.1539 71.5362 |
||||||
17.8 |
A B C Average value |
1 1 1 1 |
7.2384 7.0005 6.8546 7.0312 |
25.7441 29.6791 24.7501 26.7244 |
59.3372 57.3452 61.0382 59.2402 |
||||||
31.6 |
A B C Average value |
1 1 1 1 |
7.0105 7.7756 6.8038 7.1966 |
18.7332 15.3892 17.4572 17.1932 |
29.3407 33.4007 30.8317 31.1910 |
||||||
56.2 |
A B C Average value |
1 1 1 1 |
5.9786 5.4058 5.7304 5.7049 |
9.2845 8.1475 10.6835 9.3718 |
10.4731 12.3351 13.0241 11.9441 |
||||||
100.0 |
A B C Average value |
1 1 1 1 |
5.4599 3.7495 4.6668 4.6254 |
4.7105 7.6995 5.5585 5.9895 |
6.8650 3.6790 5.1190 5.2210 |
Table 3 Effect of light absorption of different concentration ofAmorphophallus campanulatusdry purified extract on the cells growth ofPseudokirchneriella subcapitata
Nominal test concentration [mg/L] |
replicate |
Cell density (n. cells x 104/ml) |
|||||||||
0 h |
24 h |
48 h |
72 h |
||||||||
10.0 |
A B C Average value |
1 1 1 1 |
4.1217 4.5441 5.5193 4.7284 |
25.5941 29.7601 30.3451 28.5664 |
115.8421 114.5141 112.3181 114.2248 |
||||||
17.8 |
A B C Average value |
1 1 1 1 |
5.1389 5.7563 6.3397 5.7450 |
26.3251 31.8061 32.6961 30.2758 |
107.1571 110.1811 112.7431 110.0271 |
||||||
31.6 |
A B C Average value |
1 1 1 1 |
3.5398 4.9475 4.9214 4.4696 |
30.0461 24.1771 25.0631 26.4288 |
101.4901 100.9891 98.7921 100.4238 |
||||||
56.2 |
A B C Average value |
1 1 1 1 |
5.0620 8.0731 4.0552 5.7301 |
32.2501 27.1951 28.5851 29.3434 |
108.0861 116.2961 112.3621 112.2481 |
||||||
100.0 |
A B C Average value |
1 1 1 1 |
4.5882 8.9107 2.8642 5.4544 |
24.2611 26.3421 28.7721 26.4584 |
106.1041 100.7901 106.8681 104.5874 |
The data obtained by the modified test, reported in Table 3, were analysed for the statistical comparison with control by Dunnett’s Multiple Comparison for the algal growth rate and by Bonferroni adjusted test for the yield, after analysing the normality of distribution and the homogeneity of variance by Shapiro-Wilk test and Barlett test respectively. No significant effect due to test item light absorption on the cells growth was observed, however the data will be recorded with the raw data under the code of this study.
At the end of the test the cell density in the negative control was increased on average by a factor of 100. This value complies with the validity criteria of the test, according to the mentioned guidelines, which indicate a minimum increase factor of 16.
The negative control met also the other validity criteria, with a coefficient of variation of daily growth rates of 9.5% and a coefficient of variation of average growth in replicates control cultures during the test period of 6.8%.
The growth curves for each replicate of the negative control are represented in Figure 1, the growth curves for each concentration are represented in Figures 2 to 6, while Figure 7 represents the comparison between the growth curves of the different concentrations and of the control calculated on the mean density values.
In the test solutions the algal growth rate (r) after 72 hours of exposure was inhibited by a minimum value of 7.3% for the concentration of 10.0 mg/L to a maximum value of 64.1% for the highest tested concentration, compared to the negative control.
The percentages of growth inhibition for the tested concentrations are reported in Table 4.
Table 4 Algal growth rate and inhibition caused byAmorphophallus campanulatusdry purified extract over 72 hours of exposure in comparison with control
Nominal test item concentration [mg/L] |
24 h |
48 h |
72h |
||||||||||
Mean growth rate (x10-3) |
Mean inhibition % |
Mean growth rate (x10-3) |
Mean inhibition % |
Mean growth rate (x10-3) |
Mean inhibition % |
||||||||
0 (negative control) |
64.8 |
----- |
67.3 |
----- |
64.0 |
----- |
|||||||
10.0 |
81.4 |
-25.6 |
73.2 |
-8.8 |
59.3 |
7.3 |
|||||||
17.8 |
81.3 |
-25.4 |
68.5 |
-1.7 |
56.7 |
11.4 |
|||||||
31.6 |
82.2 |
-26.8 |
59.3 |
11.9 |
47.8 |
25.3 |
|||||||
56.2 |
72.6 |
-11.9 |
46.6 |
30.7 |
34.5 |
46.2 |
|||||||
100.0 |
63.8 |
1.6 |
37.3 |
44.6 |
23.0 |
64.1 |
The statistical analysis was carried out by the mean of CETIS elaboration software v1.026D, which automatically selects the more appropriated statistic analysis. In this case the ErC calculation was performed using a linear interpolation at 24 and 48 hours observation and a non linear regression analysis at 72 hours.
The ErC10, the ErC20and the ErC50for each observation time together with their confidence limits (LCL, Lower Confidence Level and UCL, Upper Confidence Level) based on nominal product concentrations were reported in the following table:
Time |
ErC10(mg/L) |
ErC20(mg/L) |
ErC50(mg/L) |
||||
24 h |
70.06 (47.94 – n.d.) |
> 100.0 (n.d. – n.d.) |
> 100.0 (n.d. – n.d.) |
||||
48 h |
25.73 (20.23 – 31.49) |
37.61 (29.15 – 45.12) |
> 100.0 (n.d. – n.d.) |
||||
72 h |
12.52 (5.41 – 19.85) |
24.61 (16.97 – 32.58) |
67.64 (57.35 – 78.96) |
n.d. not determined
After 72 hours of exposure, yield (y) decreased by a minimum value of 29.0% for the nominal concentration of 10.0 mg/L, to a maximum value of 95.7% for the highest concentration, compared to the negative control.
The percentages of growth inhibition in terms of biomass for the tested concentrations are reported in Table 5.
Table 5 Algal yield and growth inhibition caused byAmorphophallus campanulatusdry purified extract over 72 hours of exposure in comparison with negative control
Nominal test item concentration (mg/L) |
Mean biomass at 72h (cell/ml) |
Mean growth inhibition % |
0 (Negative control) |
1003008 |
----- |
10.0 |
715362 |
29.0 |
17.8 |
592402 |
41.3 |
31.6 |
311910 |
69.6 |
56.2 |
119441 |
89.0 |
100.0 |
52210 |
95.7 |
The EyCxcalculation was performed by a linear interpolation analysis. The EyC10, the EyC20and the EyC50at 72 hours together with their confidence limits (LCL, Lower Confidence Level and UCL, Upper Confidence Level) were as reported below :
Time |
EyC10(mg/L) |
EyC20(mg/L) |
EyC50(mg/L) |
||||
72 h |
3.45 (2.49 – 4.70) |
6.90 (4.98 – 9.39) |
22.03 (19.29 – 24.16) |
The concentration-response plots at 72 hours for growth rate and yield end-points are shown respectively in Figures 8 and 9 for the results expressed as nominal product concentrations,
At the beginning of the test period, the pH values of test medium ranged between 7.87 and 8.02, and at the end the range was between 8.13 and 9.02. The mean values are reported in Table 6.
The pH in the control varied by 1.11 units, so the pH validity criterium was met.
Table 6 pH values in the test media at the start and at the end of the test.
Nominal test item concentration |
|
|
(mg/L) |
pH |
pH (mean values) |
Negative control |
7.89 |
9.02 |
10.0 |
8.02 |
8.45 |
17.8 |
7.90 |
8.41 |
31.6 |
7.93 |
8.18 |
56.2 |
7.88 |
8.17 |
100.0 |
7.87 |
8.13 |
The temperature under the test light was in the range 22.9 – 25.0 °C along the exposure time, with a mean value of 24.0 °C and a standard deviation of 0.5 °C during the test period, according to the OECD recommended range (24.0±2.0 °C).
The registration of the temperature is reported in Figure 10.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.