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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
toxicity to terrestrial plants: long-term
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
Version / remarks:
July 2006
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

1
Chemical structure
Reference substance name:
Bis(2-propylheptyl) phthalate
EC Number:
258-469-4
EC Name:
Bis(2-propylheptyl) phthalate
Cas Number:
53306-54-0
Molecular formula:
C28H46O4
IUPAC Name:
1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
Details on test material:
- Name of test material (as cited in study report): Palatinol 10-P
- Analytical purity: 98.3 area-% (GC, DB-1), 98.8 area-% (GC, DB-5 HT), see report No 17L00129
- Homogeneity: given
- Lot/batch No.: F151_2017
- Expiration date of the lot/batch: 07 Dec 2018

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
no
Details on preparation and application of test substrate:
The control and test item treatments were applied once at the beginning of the study. The respective test item amount was weighed out for each test item concentration on quartz sand (1% of the entire soil amount per concentration) and blended thoroughly with quartz sand. Afterwards the test item - quartz sand mixture and an appropriate amount of demineralised water (adjusting the soil to a moisture of 50 % and 45 % of the maximum water holding capacity (MWHC), respectively) were added to the soil. Subsequently, the soil was mixed carefully with a mixer (3 min) to ensure a homogeneous distribution.
The treated soil was transferred to the test container and the seeds were sown.

Test organisms

open allclose all
Species:
Avena sativa
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
KWS Contender
Origin: KWS Lochow GmbH, Ferdinand-von-Lochow-Straße 5, 29303 Bergen, Germany
Species:
Allium cepa
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
Exhibition
Origin: Hild Samen GmbH, Postfach 1161, 71666 Marbach, Germany
Species:
Beta vulgaris
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
Finola KWS3
Origin: KWS Saat SE, Grimsehlstraße 31, 37574 Einbeck, Germany
Species:
Brassica napus
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
Sherlock
Origin: KWS Saat SE, Grimsehlstraße 31, 37574 Einbeck, Germany
Species:
Lactuca sativa
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
Mafalda
Origin: Hild Samen GmbH, Postfach 1161, 71666 Marbach, Germany
Species:
Glycine max (G. soja)
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
Obelix
Origin: Delley Samen und Pflanzen AG, Schloss Delley 40, route de Portalban, CH-1567 Delley, Switzerland
Species:
other: Allium tuberosum
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
Shiva
Origin: Hild Samen GmbH, Postfach 1161, 71666 Marbach, Germany

Study design

Test type:
seedling emergence and seedling growth test
Study type:
laboratory study
Substrate type:
artificial soil
Remarks:
LUFA 2.2
Limit test:
no
Total exposure duration:
21 d
Remarks:
In the 2nd definitive study the test for salad, onion and garlic chives was conducted over a period of 28 days.

Test conditions

Test temperature:
1st definitive study - actual: 18.6 - 23.7 °C
2nd definitive study - actual: 17.3 - 25.3 °C
Moisture:
1st definitive study - actual: 46.4 - 98.8% relative humidity
2nd definitive study - actual: 44.6 - 97.4% relative humidity
Details on test conditions:
Sowing: Test containers were filled each with the same amount of treated soil and seeding holes were made with a seedling pistil. One seed was given into each hole and covered with soil. During cultivation the test containers were bottom watered and fertilized as necessary.
Number of seeds:
Oats, onion, garlic chives, sugar beet, rape, lettuce: 5 seeds per test container, corresponding to 40 seeds per test concentration
Soybean: 3 seeds per test container, corresponding to 24 seeds per test concentration
Nominal and measured concentrations:
1000 - 500 - 250 - 125 - 62.5 mg/kg DW + Control
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
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:
other: shoot height, fresh weight, number of emerged seedlings
Key result
Species:
Allium cepa
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Key result
Species:
other: Allium tuberosum
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Key result
Species:
Beta vulgaris
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:
other: shoot height, fresh weight, number of emerged seedlings
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:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Lactuca sativa
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
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:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Allium cepa
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
other: Allium tuberosum
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Beta vulgaris
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Lactuca sativa
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Avena sativa
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:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Allium cepa
Duration:
28 d
Dose descriptor:
EC25
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
other: Allium tuberosum
Duration:
28 d
Dose descriptor:
EC25
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Beta vulgaris
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:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Brassica napus
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:
other: shoot height, fresh weight, number of emerged seedlings
Species:
Lactuca sativa
Duration:
28 d
Dose descriptor:
EC25
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: shoot height, fresh weight, number of emerged seedlings
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:
other: shoot height, fresh weight, number of emerged seedlings
Details on results:
The basis for effect in the different species refers to shoot height, shoot fresh weight as well as to the number of emerged seedlings.
Reported statistics and error estimates:
Percentage of inhibition
The percentage of inhibition of biomass growth (shoot height, shoot fresh weight) and rate of emergence were calculated in relation to the control.
All dead plants were excluded from the calculation of shoot height and fresh weight (above-ground biomass).
NOEC/LOEC of biomass growth/emergence
One Way Analysis of Variance (ANOVA) and Dunnett's test were 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 a-value for ANOVA (acceptable probability of incorrectly concluding that there is a
difference) is a =0.05.
Software
The data for the tables in the report were computer generated and rounded for presentation from the fully derived data.
Consequently, if calculated manually based on the given data, minor deviations may occur from these figures.
Excel, Microsoft Corporation
SigmaPlot (Windows), SPSS Incorporation

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Potential toxic effects of the test item were assessed on day 7, 14, 21 and 28 by visual observations (number of emerged seedlings and phytotoxic effects) and at test end by shoot height and shoot fresh weight determination.
No test item related phytotoxic effects and mortality occurred during the test period for all plant species.