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Administrative data

Endpoint:
toxicity to terrestrial arthropods, other
Remarks:
short-term and long-term
Type of information:
other: statement
Adequacy of study:
key study
Study period:
June 2019
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 18th November to 23rd December 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study well documented according to Guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not applicable
Oxygen conditions:
aerobic
Inoculum or test system:
sewage, predominantly domestic, adapted
Details on inoculum:
Fresh activated sludge from a biological waste treatment plant treating predominantly domestic sewage (City of Geneva, Aire) was used.
The sludge is collected in the morning, washed three times in the mineral medium (by centrifuging at 1000 g for 10 minutes, discarding the supernatant and resuspending in the mineral medium) and kept aerobic until being used on the same day.
Duration of test (contact time):
28 d
Initial conc.:
100 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
A measured volume of inoculated mineral medium, containing a known concentration of test substance (100 mg/I) as the nominal sole source of organic carbon, is stirred in a closed flask at a constant temperature (± 1 °C) for up to 28 days. The consumption of oxygen is determined by measuring the quantity of oxygen (produced electrolytically) required to maintain constant the gas volume in the respirometer flask. Evolved carbon dioxide is absorbed in soda lime pellets. The amount of oxygen taken up by the microbial population during biodegradation of the test chemical (corrected for uptake by blank inoculum, run in parallel) is expressed as a percentage of ThOD (Theoretical Oxygen Demand, calculated from the elemental composition, assuming that carbon is oxidized to carbon dioxide and hydrogen to water).
Reference substance:
benzoic acid, sodium salt
Preliminary study:
not applicable
Test performance:
Every day the oxygen consumption of each flask is recorded and correct temperature and stirring are checked.
At the end of the test period (normally 28 days), the pH of each flask
Parameter:
% degradation (O2 consumption)
Value:
29
Sampling time:
2 d
Parameter:
% degradation (O2 consumption)
Value:
77
Sampling time:
7 d
Parameter:
% degradation (O2 consumption)
Value:
81
Sampling time:
12 d
Parameter:
% degradation (O2 consumption)
Value:
82
Sampling time:
21 d
Parameter:
% degradation (O2 consumption)
Value:
82
Sampling time:
28 d
Details on results:
Every day the oxygen consumption of each flask is recorded and correct temperature and stirring are checked.
At the end of the test period (normally 28 days), the pH of each flask is measured again.
The curves obtained with the reference substance alone and with HELIOTROPINE CRYSTALS + reference substance show no toxic effect of HELIOTROPINE CRYSTALS on the micro-organisms at the test concentration.
Results with reference substance:
Degradation of sodium benzoate exceeds 40% after 7 days and 65% after 14 days: the activity of the inoculum is thus verified and the test is considered as valid.
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
HELIOTROPINE CRYSTALS (piperonal) undergoes 82 % biodegradation after 28 days in the test conditions. Biodegradation starts on day 2 and reaches 81 % at the end of the 10-day window (days 2 to 12).
Thus, HELIOTROPINE CRYSTALS (piperonal) should be regarded as readily biodegradable according to this test.
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 11th November 1997 to 11th December 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study in compliance with international recognized guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
not specified
GLP compliance:
yes
Type of method:
HPLC method
Partition coefficient type:
octanol-water
Analytical method:
high-performance liquid chromatography
Type:
log Pow
Partition coefficient:
1.2
Temp.:
35 °C
Remarks on result:
other: data on pH not available

The determination was performed at 35 °C (temperature of the column), but the value obtained above can be considered to represent the value at an unspecified, probably ambient temperature since no mention is made in the guidelines of the temperature at which the tabulated reference substances log Pow values were determined. Partition coefficients of the test and reference substances are assumed to vary with temperature in the same way.

Conclusions:
The partition coefficient n-octanol/water of heliotropin (piperonal) is log Pow: 1.2 at 35°C
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 February 2013 – 28 February 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant study in compliance with international recognized guidelines.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Water solubility:
1.1 g/L
Temp.:
10 °C
pH:
> 5 - < 6.9
Remarks on result:
other: standard deviation: 0.026, replicates of three days
Water solubility:
1.4 g/L
Temp.:
20 °C
pH:
> 4.8 - < 5.8
Remarks on result:
other: standard deviation: 0.008, replicates of three days
Details on results:
The difference between the concentrations of the test substance of day 1 to 3 at 10 °C and 20 °C was <15 % and the concentrations of the test substance showed no relevant tendency. Therefore the mean of day 1 - 3 was taken as the solubility of the test substance at both temperatures, according to the guidelines.

As the temperature coefficient of the solubility of the test substance was <3 % (i.e. 2.8 %) per °C, the solubility was not determined at three temperatures, in agreement with the guideline.
Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
The water solubility of the test substance is 1.4 ± 0.008 g/L at 20ºC.
Executive summary:

Following the flask method detailed within OECD 105, the solubility of the test substance was determined to be 1.4 ± 0.008 g/L (1400 mg/L) at 20ºC based on the mean of day 1 – 3. As the temperature coefficient of the solubility of the test substance was <3% (i.e. 2.8%) per ºC, the solubility was not determined at three temperatures.

Reason / purpose for cross-reference:
reference to other study
Reference

The substance was toxic to Cyprinus carpio when tested according to OECD 203. The 96 hr LC50 for was reported to be 2.5 mg/L meas. (geom. mean).

 

The substance was harmful to Daphnia magna when tested according to OECD 202. The 48 hr EC50 for was reported to be 52 mg/L (nominal).

 

The substance was harmful to aquatic algae when tested according to OECD 201. The 72 hr EC50 based on growth rate was reported to be 31 mg/L (TWA concentration).

The substance was not acutely toxic to microorganisms when tested according to OECD 301F. The data obtained with the reference substance alone and with HELIOTROPINE CRYSTALS (piperonal) + reference substance show no toxic effect of HELIOTROPINE CRYSTALS (piperonal) on the micro-organisms at the test concentration (100 mg/L).

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Argumentation is provided for 'study scientifically not necessary / other information available', based on available physico-chemical, fate and ecotoxicological properties information and in agreement with column 2 of Regulation (EC) No 1907/2006 Annex IX section 9.4. Effects on terrestrial organsims.
GLP compliance:
no
Application method:
other: none (no test performed)

Test material

Constituent 1
Chemical structure
Reference substance name:
Piperonal
EC Number:
204-409-7
EC Name:
Piperonal
Cas Number:
120-57-0
Molecular formula:
C8H6O3
IUPAC Name:
1,3-benzodioxole-5-carbaldehyde
Test material form:
solid: particulate/powder
Details on test material:
- Substance name (as stated in test report): Piperonal or Heliotropine

Sampling and analysis

Analytical monitoring:
not required

Test substrate

Details on preparation and application of test substrate:
not applicable - no test performed

Test organisms

Test organisms (species):
other: none (no test performed)

Study design

Study type:
other: statement based on available physico-chemical, fate and ecotoxicological property information

Test conditions

Details on test conditions:
not applicable - no test performed

Results and discussion

Effect concentrations
Key result
Remarks on result:
not measured/tested
Details on results:
The substance is readily biodegradable and has a low log Pow, thus it is not (very) persistent nor has it a high potential to adsorb to sludge or to soil. The latter is confirmed through the low calculated Koc, based on the experimentally determined log Pow.

Based on these properties, direct or indirect exposure of the soil compartment is unlikely. This was assessed in the exposure and risk assessment performed in the CSR.

In the absence of toxicity data for soil organisms, the equilibrium partitioning method (EPM, using the calculated Koc) was applied as a screening method to assess the hazard to soil organisms. The derived PNECsoil value is low (< 1 µg/kg dry weight). The exposure assessment was performed for all exposure scenarios as well as for the combined exposure scenarios. The resulting soil exposure concentrations were even lower than the PNECsoil, thus resulting in RCR’s below 1. It can be concluded that, based on the use of the screening PNECsoil, no unacceptable risk is present.

No further data on terrestrial arthropods is thus necessary.

Applicant's summary and conclusion

Conclusions:
Taking into account the available information of the substance with regard to environmental relevance and exposure of the soil compartment, it is considered scientifically justified to waive testing of this substance for toxicity to terrestrial arthropods.