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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
toxicity to terrestrial plants: long-term
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2014-06-04 to 2014-06-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, no deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
940-373-5
EC Number:
940-373-5
IUPAC Name:
940-373-5
Test material form:
other: waxy solid
Details on test material:
- Name of test material (as cited in study report): C18/C18 unsatd.-Glucamide
- Physical state: Yellowish waxy solid
- Analytical purity: 100 %
- Sum formula: C25H49NO6 (C18 unsatd.-Glucamide) and C25H51NO6 (C18 satd.-Glucamide)
- Molecular weight:
C18 unsatd.-Glucamide: 459.67 g/Mol
C18 satd.-Glucamide 461.68 g/Mol
- Storage condition of test material: Room temperature, protected from light, in original container.

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
No analytical monitoring

Test substrate

Vehicle:
no
Details on preparation and application of test substrate:
- Method of mixing into soil (if used):The control and test item treatments were applied once at the beginning of the study.
Soil amount per test concentration and control: 16.86 kg, divided into two parts, each 8.43 kg
The respective test item amount was weighed out for each test item concentration, demineralised water was added and stirred at approximately 50 °C for 1 hour on a magnetic stirrer. Afterwards the test item solution and an appropriate amount of demineralised water (adjusting the soil to a moisture of 50 % of the maximum water holding capacity (WHC)) was added to the soil. Subsequently the soil was mixed carefully with the soil using a mixer to ensure a homogeneous distribution. The treated soil was transferred to the test container and the seeds were sown


- Control: Untreated soil

Test organisms

open allclose all
Species:
Brassica napus
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: Rape
- Plant family: Brassicaceae
- Variety: Kadore
- Source of seed: KWS Mais GmbH, D-37555 Einbeck, Germany
- Prior seed treatment/sterilization: No
- Seed storage: The seeds were stored dark at the test facility at room temperature (22 ± 10 °C) and protected from moisture until use.
Species:
Avena sativa
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
- Common name: Oats
- Plant family: Gramineae
- Variety: Ivory
- Source of seed: NORDSAAT SAATZUCHT GMBH, 38895 Langenstein, Germany
- Prior seed treatment/sterilization: No
- Seed storage: The seeds were stored dark at the test facility at room temperature (22 ± 10 °C) and protected from moisture until use.
Species:
Glycine max (G. soja)
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: Soybean
- Plant family: Leguminosae
- Variety: Merlin
- Source of seed: Saatbau Linz, A-4021 Linz, Austria
- Prior seed treatment/sterilization: No
- Seed storage: The seeds were stored dark at the test facility at room temperature (22 ± 10 °C) and protected from moisture until use.

Study design

Test type:
seedling emergence toxicity test
Study type:
laboratory study
Substrate type:
natural soil
Limit test:
no
Total exposure duration:
21 d

Test conditions

Test temperature:
nominal: 22 +/- 10 °C
actual: 16 - 21 °C
pH:
5.48 +/- 0.03 (natural soil)
Moisture:
- relative humidity: nominal: 70 +/- 25 %, actual: 60 - 100 %
Details on test conditions:
TEST SYSTEM
- Testing facility: Dr.U.Noack-Laboratorien
- Test container (type, material, size): Plastic container (standard flower pots) with a diameter of ca. 12 cm
- Amount of soil:
Soil amount per test concentration and control: 16.86 kg, divided into two parts, each 8.43 kg

- Method of seeding: Test containers were filled each with the same amount of treated soil (see application technique) and seeding holes were made
with a seedling pistil. One seed was given in each hole and covered with soil. During cultivation the test containers were bottom watered and
fertilized as necessary.
- No. of seeds per container: 5
- No. of replicates per treatment group: 8
- No. of replicates per control: 8


SOURCE AND PROPERTIES OF SUBSTRATE (if soil): A 2:1 mixture of natural soil LUFA 2.2 (batch number: Sp2.21214) and quartz sand (12a) was used.
- Geographic location: Soil collected by LUFA Speyer (67346 Speyer, Germany), quartz sand collected by Dörentrup Quarz GmbH Co. KG (31089
Duingen, Germany)
- Pesticide use history at the collection site: No pesticide use for the last five years.
- Soil texture (if natural soil)
- grain size: - Soil taxonomic classification: loamy sand (IS)
- Soil classification system: German DIN
- Organic carbon (%): 0.60
- Storage (condition, duration): The soil has been stored at the test facility at green house conditions until use.


NUTRIENT MEDIUM (if used)
- Description:
Fertilizer: HAKAPHOS® SOFT SPEZIAL 16+8+22(+3) (0.5 ‰)
Origin: GRÜNES LANDHAUS, St. Godehard-Str. 23, 31139 Hildesheim, Germany

Nutrient Concentration [%]
Ammonium nitrogen 9.7
Nitrate nitrogen 6.3
P2O5 8
Potassium oxide 22
Magnesium oxide 3
Boron 0.03
Iron (Chelate) 0.15
Copper 0.02
Manganese 0.05
Molybdenum 0.005
Zinc 0.015


GROWTH CONDITIONS
- Photoperiod: 16 h
- Light source: Special-fluorescent tube Fluora and Daylight (OSRAM)
- Light intensity and quality: nominal: > 3500 lx, actual: 4524 ± 660
- Day/night temperatures: 22 +/- 10 °C, actual: 16 - 21 °C
- Relative humidity (%): 70 +/- 25, actual: 60 - 100
- Watering regime and schedules: Bottom watering of the test containers, including fertilizer as necessary.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
During the 21 day observation period the plants were observed every 7 days for number of emerged seedlings, number of dead plants and visual phytotoxic effects. The rating of the treated plants was done in relation to the control plants. Observations included all variations, either inhibitory or stimulatory, between the treated test replicates and the untreated control replicates. Such variations were phytotoxic symptoms (chlorosis, necrosis, wilting), formative effects and growth and development rates. At the end of the study shoot height and shoot fresh weight were measured.

- Phytotoxicity rating system (if used):


(1) Alteration of form and appearance (deformation)
(1.1) Curling / twisting / sticking or other deformation of the leaves
(1.2) Change of appearance
(1.3) Shoot deformations
(1.4) Wilting
(1.5) Leaf shedding
(1.6) Shedding of the leaf apex
(1.7) Stunted growth
(2) Discolouration of the leaves
(2.1) Lighter green
(2.2) Darker green
(2.3) Chlorosis
(2.3.1) Spots
(2.3.2) Whole leaf
(2.3.3) Veins
(2.3.4) Between veins
(2.3.5) Marginal
(2.4) Loss of colour
(2.5) Discolouration
(2.6) Discoloration of the veins
(2.7) Discoloration of the shoot
(3) Alteration of the leaf cells
(3.1) Necrosis
(3.1.1) Spots
(3.1.2) Marginal
(3.1.3) Apical
(3.1.4) Between veins
(3.1.5) Whole leaf
(3.1.6) Veins
(E) Dead plant (Number of dead plants)


Assessment of the Effects

- = no effects observed / normal growth
+/- = slight effects
+ = medium effects
++ = strong effects


VEHICLE CONTROL PERFORMED: no


TEST CONCENTRATIONS

- Range finding study
Results of the Preliminary Test: Inhibition of Shoot Fresh Weight and Emergence on day 21

Test
concentration Inhibition of shoot fresh weight [%] Inhibition of emergence
[%]
[mg/kg DW] Oats Rape Soybean Oats Rape Soybean
10 -15 -10 7 -5 -5 0
100 -13 1 7 -5 -5 0
500 2 12 11 0 0 0
1000 10 54 26 -5 0 5
Nominal and measured concentrations:
nominal:

1000 - 500 - 250 - 125 - 62.5 mg/kg DW (dry weight)
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
500 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
706 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
EC25
Effect conc.:
987 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Remarks on result:
other: 845 - > 1000 mg/kg soil dw
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
250 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
366 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC25
Effect conc.:
579 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Remarks on result:
other: 448 - 771 mg/kg soil dw
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
500 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
692 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
EC25
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot fresh weight)
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot height)
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot height)
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot height)
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot height)
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot height)
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
(Shoot height)
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Details on results:

SEEDLING EMERGENCE

The percent inhibition of shoot height, shoot fresh weight and rate of emergence is given in the tables below. The tabulated results represent
rounded values calculated on the exact raw data.


Oats: Inhibition [%] of Shoot Height, Shoot Fresh Weight and Rate of Emergence

Test concentration
[mg/kg DW] Shoot Inhibition Shoot fresh Inhibition Rate of Inhibition
height weight emergence
[cm] [%] [mg] [%] [%] [%]
Control 40.8 - 978 - 90 -
62.5 40.0 2 997 -2 100 -11
125 40.4 1 997 -2 95 -6
250 39.1 4 1052 -8 98 -9
500 40.5 1 1002 -2 93 -3
1000 40.5 1 715 27 93 -3

negative values = promoted growth bold = statistically significant inhibition

Rape: Inhibition [%] of Shoot Height, Shoot Fresh Weight and Rate of Emergence

Test concentration
[mg/kg DW] Shoot Inhibition Shoot fresh Inhibition Rate of Inhibition
height weight emergence
[cm] [%] [mg] [%] [%] [%]
Control 12.3 - 1144 - 88 -
62.5 12.5 -2 1210 -6 85 3
125 12.4 -1 1149 0 90 -2
250 12.5 -2 1152 -1 90 -2
500 11.8 4 899 21 98 -11
1000 11.3 8 692 40 80 9


Soybean: Inhibition [%] of Shoot Height, Shoot Fresh Weight and Rate of Emergence

Test concentration
[mg/kg DW] Shoot Inhibition Shoot fresh Inhibition Rate of Inhibition
height weight emergence
[cm] [%] [mg] [%] [%] [%]
Control 23.4 - 1851 - 90 -
62.5 25.9 -11 2022 -9 98 -9
125 25.5 -9 1837 1 98 -9
250 25.2 -8 1791 3 100 -11
500 25.0 -7 1757 5 98 -9
1000 25.1 -7 1598 14 95 -6


Negative values = promoted growth




Results with reference substance (positive control):
No reference substance tested
Reported statistics and error estimates:
The percent inhibition of biomass growth (shoot height, shoot fresh weight) and rate of emergence were calculated in relation to the control.

One Way Analysis of Variance (ANOVA) was carried out for the determination of statistically significant differences compared to control replicates. When
running a One Way Analysis of Variance a Normality test and an Equal Variance test were done first. P-values for both Normality and Equal Variance test are
0.05. The -value for ANOVA (acceptable probability of incorrectly concluding that there is a difference) is =0.05.

EC10, EC25 and EC50 values were calculated by sigmoidal dose-response regression. Calculation of the confidence intervals for EC-values was carried out using standard procedures.


Any other information on results incl. tables

Visual Phytotoxicity on Day 21

 

Oats: Visual Observations and Number of Dead Plants on Day 21

Test
concentration

[mg/kg DW]

Phyto-
toxic
effects

Phytotoxic effects

Replicate

1

2

3

4

5

6

7

8

control

-

-

-

-

-

-

-

-

    62.5

-

-

-

-

-

-

-

-

  125

-

-

-

-

-

-

-

-

  250

-

-

-

-

-

-

-

-

  500

-

-

-

-

-

-

-

-

1000

-

-

-

-

-

-

-

-

 

Rape: Visual Observations and Number of Dead Plants on Day 21

Test
concentration

[mg/kg DW]

Phyto-
toxic
effects*

Phytotoxic effects

Replicate

1

2

3

4

5

6

7

8

control

-

-

-

-

-

-

-

-

    62.5

-

-

-

-

-

-

-

-

  125

-

-

-

-

-

-

-

-

  250

(3.1.5)

-

+/-

-

-

-

-

-

-

  500

(1.7)

-

+

-

-

+/-

-

+/-

-

 

(3.1.5)

-

+/-

-

-

-

-

-

-

1000

-

-

-

-

-

-

-

-

Soybean: Visual Observations and Number of Dead Plants on Day 21

Test
concentration

[mg/kg DW]

Phyto-
toxic
effects

Phytotoxic effects

Replicate

1

2

3

4

5

6

7

8

control

-

-

-

-

-

-

-

-

    62.5

-

-

-

-

-

-

-

-

  125

-

-

-

-

-

-

-

-

  250

-

-

-

-

-

-

-

-

  500

-

-

-

-

-

-

-

-

1000

-

-

-

-

-

-

-

-

- = no effects observed / normal growth

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Potential toxic effects of the test item were assessed on day 7, 14 and 21 by visual observations (phytotoxic effects and number of dead plants) and on day 21 by shoot height and shoot fresh weight determination. After 21 days no test item related phytotoxic effects were observed for all tested plant species at test concentrations up to 1000 mg/kg DW.

The NOEC values as well as the calculated EC-values with confidence ranges are given in the tables below.

Shoot Height: NOEC, EC10-, EC25- and EC50- Values with Confidence Range (p)

Species NOEC EC10 EC25 p = 95% EC50 p = 95%
[mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW]
Oats 1000 > 1000 > 1000 – > 1000 –
Rape 1000 > 1000 > 1000 – > 1000 –
Soybean 1000 > 1000 > 1000 – > 1000 –
-) Not determinable


Shoot Fresh Weight: NOEC, EC10-, EC25- and EC50- Values with Confidence Range (p)

Species NOEC EC10 EC25 p = 95% EC50 p = 95%
[mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW]
Oats 500 706 987 845 - > 1000 > 1000 –
Rape 250 366 579 448 - 771 > 1000 –
Soybean 500 692 > 1000 – > 1000 –


Rate of Emergence: NOEC, EC10-, EC25- and EC50- Values with Confidence Range (p)

Species NOEC EC10 EC25 p = 95% EC50 p = 95%
[mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW]

Oats 1000 > 1000 > 1000 – > 1000 –
Rape 1000 > 1000 > 1000 – > 1000 –
Soybean 1000 > 1000 > 1000 – > 1000 –


Executive summary:

The phytotoxicity of the test item C18/C18 unsatd.-Glucamide (batch number:SN119/13/3-8) to three terrestrial plant species was determined in a seedling emergence test over a period of 21 days, from 2014 -06 -04 to 2014 -06 -25 according to OECD 208 (July 2006) at Dr.U.Noack-Laboratorien, 31157Sarstedt, Germany.

Test systems were one monocotyledon, oats (Gramineae), and two dicotyledons, rape (Brassicaceae) and soybean (Leguminosae).

The test was conducted with the test concentrations1000 - 500 - 250 - 125 -62.5 mg/kg DW (factor 2).

The test item was incorporated into the soil in which the seeds were sown afterwards. The test containers were bottom watered with nutrient solution as needed. The toxic effects of the test item were determined on day 7, 14 and 21 by visual observations (number of emerged seedlings and phytotoxic effects) and on day 21 by shoot height and shoot fresh weight determination.

After 21 days no test item related phytotoxic effects were determined for all tested plant species up to the test concentration 1000 mg/kg DW (section12.3.3).

 

 

The statistically calculated NOEC values, as well as thecalculated EC10-, EC25- and EC50-values, are summarized in the tables below.

 

The results of the control for all plant species met the required validity criteria. Therefore, the test is considered to be valid.

 


 

Shoot Height:NOEC, EC10-, EC25- and EC50- Values with Confidence Range (p)

Species

NOEC
[mg/kg DW]

EC10
[mg/kg DW]

EC25
[mg/kg DW]

p = 95%
[mg/kg DW]

EC50
[mg/kg DW]

p = 95%
[mg/kg DW]

Oats

1000

> 1000

> 1000

> 1000

Rape

1000

> 1000

> 1000

> 1000

Soybean

1000

> 1000

> 1000

> 1000

 

 

Shoot Fresh Weight:NOEC, EC10-, EC25- and EC50- Values with Confidence Range (p)

Species

NOEC
[mg/kg DW]

EC10
[mg/kg DW]

EC25
[mg/kg DW]

p = 95%
[mg/kg DW]

EC50
[mg/kg DW]

p = 95%
[mg/kg DW]

Oats

500

706

987

845 - > 1000

> 1000

Rape

250

366

579

448 - 771

> 1000

Soybean

500

692

> 1000

> 1000

 

Number of Emerged Seedlings: NOEC, EC10-, EC25- and EC50- Values with Confidence Range (p)

Species

NOEC
[mg/kg DW]

EC10
[mg/kg DW]

EC25
[mg/kg DW]

p = 95%
[mg/kg DW]

EC50
[mg/kg DW]

p = 95%
[mg/kg DW]

Oats

1000

> 1000

> 1000

> 1000

Rape

1000

> 1000

> 1000

> 1000

Soybean

1000

> 1000

> 1000

> 1000

-)    Not determinable