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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to aquatic plants other than algae

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to aquatic plants other than algae
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Oct - 02 Nov 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: U.S. EPA-FIFRA PesticideAssessment Guideline § 123-2 Tier 2 "Non-target AquaticPlant Toxicity"
Deviations:
yes
Remarks:
Deviation to OECD 221: Different growth medium used, test duration was 15 d instead of 14 d, no measurement of another another parameter (total frond area, dry weight or fresh weight) besides frond number, no assessment based on specific growth rate made
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 (control), 3.03, 6.05, 12.1, 24.2, 48.4 and 96.8 mg a.i./L
- Sampling method: Samples were taken at day 0 and 15
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test concentrations were prepared by adding aliquots of the stock solution (1000 mg test item/L) to a total of 1000 ml test medium.
- Controls: control: dilution water only, solvent control: 1 mL DMF/L
- Chemical name of vehiclle: dimethylformamide
- Concentration of vehicle in test medium: stock solution: 100%, final test solutions: max. 1 mL/L, control: 0%, solvent control: 1 mL/L
- Test concentration separation factor: 2
Test organisms (species):
Lemna gibba
Details on test organisms:
TEST ORGANISM
- Common name: gibbous duckweed
- Strain: G3
- Source: laboratory stock culture (originally obtained from Dr. Janet Slovin, Horticulture Crops Quality Laboratory,U.S. Department of Agriculture, Beltsville, USA)
- Age of inoculum: < 14 days
- Method of cultivation: maintained under sterile conditions in glass dishes filled with Hoagland E medium without Sucrose, Yeast extract, Bactotryptone and EDTA under illumination of 5000 lux ± 15% and temperature of 25 ± 2°C. Transfers are made regularly into fresh mediumto provide less than 14-day old cultures for toxicity test inoculations.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
15 d
Test temperature:
23.7 - 24.2 °C
pH:
4.6 - 6.1
Nominal and measured concentrations:
Nominal concentrations: 0 (control), 3.03, 6.05, 12.1, 24.2, 48.4 and 96.8 mg a.i./L
Mean measured concentrations: < LOD (control), 2.98, 6.05, 12.3, 25.7, 46.8 and 95.4 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Incubation chamber used: yes
- Test vessel: 400 mL glass dishes
- Type: covered with lits of glass to permit gas exchange and illumination
- Material, size, headspace, fill volume: glass, 10 cm diameter x 6 cm height,
- Type of cover: lits of glass
- Aeration: no
- Control end frond number: 189 (solvent control), 235 (control)
- No. of colonies per vessel: 5
- No. of fronds per colony: 3
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 3

GROWTH MEDIUM
- Standard medium used: yes (M-Hoagland's Medium, ASTM E 1415 -91 (modified: without EDTA, Sucrose, Yeast extract or Bactotryptone)

TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH (test start and end) and temperature (daily)

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous light
- Light intensity and quality: 5124 lux (mean of a total of 5 measurements)

EFFECT PARAMETERS MEASURED:
- Determination of frond number: manual counting (day 2, 5, 7, 9, 12 and 15)
- Determination of biomass: no
- Shoot length: no
- Shoot weight (fresh / dry): no
- Determination of frond area: no
Reference substance (positive control):
no
Duration:
15 d
Dose descriptor:
NOEC
Effect conc.:
46.8 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
frond number
Duration:
15 d
Dose descriptor:
EC50
Effect conc.:
141.8 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
frond number
Reported statistics and error estimates:
Data which did not fit a normal distribution were analyzed by the non-parametric Kruskal-Wallis' test and Dunn's Multiple Comparison test to determine if there was a significant difference between the control and treatment groups. Control data were pooled if the t-test criteria was met. If the data was not poolable, only the
corresponding solvent control data was used for further analyses.
This growth data, without previous data transformation were analyzed according to the following statistical methods: the Dunnett's test,the Bonferroni's t-test, the Tukey's test and the Williams' test.

Table 1: Measured concentrations in experimental study

Nominal concentration

[mg a.i./L]

Measured concentrations in mg a.i./L

Day 0

 

Day 15

Mean

Control

< 0.1

< 0.1<

-

Solvent control

< 0.1

< 0.1<

-

3.03

3.03

2.94

2.98

6.05

6.02

6.07

6.05

12.1

12.3

12.3

12.3

24.2

25.8

25.6

25.7

48.4

46.1

47.6

46.8

96.8

92.0

98.7

95.4

Table 2: Frond counts during test

Mean measured concentration (mg a.i/L)

Replicate

Day 0

Day 12

Day 15

Control

A

15

130

199

B

15

136

231

C

15

162

274

Mean

15

143

235

Solvent control

A

15

115

178

B

15

128

189

C

15

126

201

Mean

15

123

189

2.98

A

15

117

237

B

15

126

201

C

15

112

208

Mean

15

118

215

6.05

A

15

140

238

B

15

151

244

C

15

157

267

Mean

15

149

250

12.3

A

15

138

219

B

15

147

242

C

15

148

217

Mean

15

144

226

25.7

A

15

144

218

B

15

118

188

C

15

132

213

Mean

15

131

206

46.8

A

15

108

156

B

15

113

186

C

15

141

225

Mean

15

121

189

95.4

A

15

82

115

B

15

104

157

C

15

119

162

Mean

15

102

145*

*Denotes statistically significant difference from pooled controls (α = 0.05) at day 15.

Table 3: Validity criteria for OECD 221 (2006)

Criterion from the guideline

Outcome

Validity criterion fulfilled

The doubling time of frond number in the control must be less than 2.5 days (60 h), corresponding to approximately a seven-fold increase in seven days and an average specific growth rate of 0.275 d-1.

Not determinable since growth rate is not determined.

 Not applicable

Validity criteria fulfilled:
not applicable
Conclusions:
The EC50 (15 d) for Lemna gibba exposed to the test item is 141.8 mg a.i./L (mean measured). The NOEC was determined to be 46.8 mg a.i./L (mean measured). Both values refer to frond number inhibition.

Description of key information

NOEC (15 d) = 46.8 mg a.i./L (frond number, mean measured, Lemna gibba, EPA-FIFRA Pesticide Assessment Guideline 123-2 Tier 2)

EC50 (15 d) = 141.8 mg a.i./L (frond number, mean measured, Lemna gibba, EPA-FIFRA Pesticide Assessment Guideline 123-2 Tier 2)

Key value for chemical safety assessment

EC50 for freshwater plants:
141.8 mg/L
EC10 or NOEC for freshwater plants:
46.8 mg/L

Additional information

A 15-day toxicity test is available assessing the toxicity of the test item to Lemna gibba G3, a species of duckweed according to EPA-FIFRA Pesticide Assessment Guideline 123-2 Tier 2. Duckweed plants were exposed under static conditions to six concentrations in the range between 2.98 and 95.4 mg a.i./L. Measured concentrations were between 95 % and 107 % of nominal concentrations. The statistical analyses indicate that the frond count values in the highest tested concentration 95.4 mg a.i./L on day 15, was significantly different from those in the controls.The NOEC (15 d) and EC50 (15 d) were determined to be 46.8 and 141.8 mg a.i./L (mean measured), respectively, based on the number of counted fronds.