Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides

Toxicity to birds

Administrative data

Endpoint:

long-term toxicity to birds

Data waiving:

other justification

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Overall, the ionic nature of the test substance supported with the predicted and experimental read across BCF values indicates a low bioaccumulation potential. Considering a conservative approach, the higher BCF value of 71 L/kg ww from the QSAR study with the test substance has been considered further for hazard/risk assessment. 

BCF (aquatic species):

71 L/kg ww

Study 1:The BCF value for the test substance were estimated using the regression-based methodology of the BCFBAF v3.01 program (EPI Suite v4.11). Since the test substance is a ionic and UVCB with similar constituents varying mainly in carbon chain lengths, the BCF values were predicted for the individual components using regression method, followed by the determination of an overall weighted-average. SMILES codes were used as the input parameter. Based on the regression-based method for ionic substances and log Kow values for the individual constituents, the BCF values were predicted to be 70.8 L/kg ww (log BCF = 1.85) (US EPA, 2020)indicating a low bioaccumulation potential. On comparing with domain descriptors, not all constituents were found to meet the log Kow domain criteria as defined in the BCFBAF user guide of EPISuite. Further, taking into consideration the model’s training set and validation set statistics and the fact that the training set only contains 61 ionic compounds, the BCF predictions for the individual constituents are considered to be reliable with moderate confidence.

Study 2: A study was conducted to determine the aquatic bioaccumulation of the 14C-radiolabelled read across substance, C16-18 DAQ in Lepomis macrochirus (bluegill fish) under continuous flow-through conditions, according to OECD 305. The bluegill were exposed to nominal 20 µg/L concentrations of 14C-labeled test substance in aerated, carbon-filtered well water and to 23 µg/L in town river water under continuous flow conditions for 49 days, followed by a 21-d depuration period.. No solvent was used in the two tests. The 14C-test substance equilibrated in the test waters for 13 d prior to introducing the fish into the 30 L glass test chambers. The 115 fish in the two exposure aquaria and the 50 fish in the two control tanks were fed trout chow daily during testing. The river water was sampled at Town River, Massachusetts, and contained 2-84 mg/L suspended solids, 0.04-0.59 mg/L MBAS (methylene blue active substances) and 10-15 mg/L DBAS (disulfine blue active substances). The pH ranged from 6.4-7.7 and total hardness was 14-38 mg/L (CaCO3). Radiometric analyses in the selected fish tissues revealed that the mean steady state bioconcentration factor (BCF) in the non-edible (viscera) and whole-body fish tissue during the 49 days of exposure to be 94 and 13 L/kg ww in river water and 256 and 32 L/kg ww in well water respectively. In both waters, the test substance did not concentrate to a significant degree in edible tissue (BCF of the fillets < 5 L/kg). In a depuration phase in well water, 93% of the accumulated radioactivity was eliminated from the inedible tissues after 14 days. Overall, these results demonstrated that testing cationic surfactants under more realistic conditions (in river water) give lower bioavailability compared to studies using laboratory water (Lewis & Wee, 1983). Under the conditions of the study, the whole body bluegill BCF values were determined to be 13 L/kg ww in river water and 32 L/kg ww in well water, indicating a low bioaccumulation potential (Lewis, 1983).Based on the results of the read across study, similar low bioaccumulation potential can be expected for the test substance.

Besides these studies, the following table gives an overview of the available bioconcentration/bioaccumulation data on the read across substance C18 DAQ (also known as DODMAC) which has been litsted and reviewed in its EU RAR (EU, 2002) and the ECETOC Technical Report No. 53 (ECETOC, 1993). References mentioned below can be found in these two reports as well.

Env. Compartment	Endpoint	Type	Value	Accumulation potential	Remark
Freshwater	BCFfish	measured	13 L/kg wwt.	low	Lewis et al, 1983
Freshwater sediment	BSAFsediment	measured	0.28	low	Conrad, 1999
Freshwater sediment	BSAFsediment	measured	0.78	low	Comber, 2000
Soil	BCFworm	estimated	3 L/kg wwt.	low	estimated from BCFfish

In the EU RAR, the following assessment of the data is given:

The short-term uptake (24 h) of C18 DAQ by juvenile Pimephales promelas was assessed in a flow-through system with laboratory water and two different concentrations of humic acids (Versteeg & Shorter, 1992). A depuration phase of 72 hours followed. Compared with the laboratory water controls 6.8 mg/L humic acids decreased the uptake rate by a factor of 20 and increased the depuration rate two-fold.

These values together with the results from the study with C16 -18 and C18 -unsatd. DAQ (Lewis et al., 1983), indicate the dependence of the BCF-values on the surrounding medium which is also obvious in ecotoxicological testing. Based on test results with laboratory water, a bioaccumulation is indicated, but it is assumed that it is low under environmental conditions. A BCF of 13 L/kg is used in the risk assessment, assuming fish to be representative for all aquatic organisms. It should be pointed out, that for the diversity of organisms and environmental conditions the bioaccumulation potential (bioconcentration and biomagnification) is not known. A relatively simple microcosm study might clarify these uncertainties.

Bioaccumulation of 14C-labelled C18 DAQ by Lumbriculus variegatus from a natural sediment was measured over a period of 28 days. The total organic carbon content of the sediment was 1.73%. Worms were exposed to the C18 DAQ concentrations in the sediment in the range of 150 - 5800 mg/kg dw. After 28 days the C18 DAQ tissue concentration in the worms was measured by liquid scintillation counting. A Biota Sediment Accumulation factor (BSAF) of 0.28 was derived from the experimental data. As the concentration in the worms was only measured at the end of the 28 day test period it is not clear whether equilibrium was reached (Conrad et al., 1999).

The aim of a second experiment was the identification of the main uptake routes of C18 DAQ by Lumbriculus variegatus from the sediment. For this test feeding and non-feeding worms were exposed to a sediment containing 8.7 mg/kg of C18 DAQ. A viable non-feeding worm was generated by removing the head of an intact feeding worm. The new worm is unable to ingest sediment for up to 6- 8 days. The use of non-feeding worms allows the contribution of ingestion as an uptake route to be assessed. A 13 day bioaccumulation study with feeding and non-feeding Lumbriculus variegatus showed that the main route of uptake for C18 DAQ was via sediment ingestion. At Day 5 a comparison of tissue concentrations between the feeding and non-feeding worms showed that around 86% of the body burden in the feeding worms could be attributed to ingestion (Conrad et al., 1999).

Bioaccumulation of14C-labelled C18 DAQ by Tubifex tubifex from a natural sediment was measured over a period of 28 days. The total organic carbon content of the sediment was 1.73%. Worms were exposed to the C18 DAQ concentrations in the sediment in the range of 300-5000 mg/kg dw. After 28 days the C18 DAQ tissue concentration in the worms was measured by liquid scintillation counting. A BSAF of 0.78 was derived from the experimental data. As the concentration in the worms was only measured at the end of the 28 day test period it is not clear whether equilibrium was reached (Comber/Conrad, 2000).

To evaluate the uptake of C18 DAQ (purity > 98%) by plants, soil experiments were conducted with tomato, bean, cucumber and radish seedlings. C18 DAQ was applied to soil adsorbed to activated sludge (2 g/kg) and a concentration of 2 mg DODMAC/kg soil was achieved. Concentrations of 0.02 to 0.05 mg/kg were found in the shoots of the plant seedlings and the radish roots after 28 to 36 days exposure (Lötzsch et al., 1984).

Overall, the ionic nature of the test substance supported with the predicted and experimental read across BCF values indicates a low bioaccumulation potential. Considering a conservative approach, the higher BCF value of 71 L/kg ww from the QSAR study with the test substance has been considered further for hazard/risk assessment. 

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 20, 2010 to Junne 28, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

yes

Details on preparation and application of test substrate:

No data

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworms
- Source: Bred under standardised conditions (see OECD 207, in a breeding medium of cattle manure, peat, sand, calcium carbonate and straw, fed with cattle manure, stored at room temperature) by IBACON
- Age at test initiation (mean and range, SD): 9 to 10 m, with well developed clitellum, age range between test individuals not differing by more than 4 wk
- Weight at test initiation (mean and range, SD): 300- 599 mg

ACCLIMATION
- Acclimation period: 1 d
- Acclimation conditions (same as test or not): In artificial soil, under test conditions
- Health during acclimation (any mortality observed): No data

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

8 wk

Remarks:

Exposure Time of Offspring: Additional 28 d

Post exposure observation period:

None

Test temperature:

20- 22 °C

pH:

6.0 -6.2

Moisture:

30.5 - 36.9 % (52.6% -63.6 % of the maximum water holding capacity)

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Plastic boxes (18.3 cm x 13.6 cm x 6 cm, tapered towards the bottom, with a soil surface of approximately 16.5 cm x 11.5 cm = 189.75 cm2 ) with perforated transparent lids to enable exchange of air, to minimise evaporation from the artificial soil, and to prevent the worms from escaping.
- Amount of soil or substrate: 664.6 g of the prepared soil (500 g dry weight plus 159.6 g water plus 5 g food).
- No. of organisms per container (treatment): 10 per replicate, i.e. 80 individuals per control, 40 individuals per test item treated group
- No. of replicates per treatment group: 4
- No. of replicates per control: 8


SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Artificial soil according to OECD 222
- Composition (if artificial substrate): 10% Sphagnum-peat, air-dried and finely ground (2 mm with no visible plant remains); (Floragard, Vertriebs GmbH fur Gartenbau, 26138 Oldenburg, Germany), 20% Kaolin clay (Kaolinite content >30%) (ErbslOh, 65558 Lohrheim, Germany), approximately 0.5% calcium carbonate (CaC03) added to adjust pH to 6.0 ± 0.5 (Merck, 64293 Darmstadt, Germany), approximately 69.5% fine quartz-sand (F34) containing more than 50% by mass of particle size 0.05 mm to 0.2 mm; (Quarzwerke Frechen, Postfach 1780, 50207 Frechen, Germany)
- Organic carbon (%):
- Maximum water holding capacity (in % dry weigth): 58 %

OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h dark
- Light intensity: 400 -800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, weight change, feeding activity and reproduction rate were
determined

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

Nominal and measured concentrations:

Nominal: 0, 62.5, 125, 250, 500, 1000 mg/kg

Reference substance (positive control):

yes

Remarks:

Luxan Carbendazim 500 FC

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

ca. 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and weight

Key result

Duration:

56 d

Dose descriptor:

NOEC

Effect conc.:

ca. 500 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

- Mortality at end of exposure period: No
Please refer Table 1. in attached background material

Results with reference substance (positive control):

- Results with reference substance valid: Yes
- Relevant effect levels: EC50 for reproduction was calculated as 1.47 mg carbendazim/kg soil dry weight

Reported statistics and error estimates:

Standard procedures, Fisher's Exact Test (mortality), Dunnett's t-test (weight
changes and reproduction)

For result tables, kindly refer to the attached background material section of the IUCLID.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the NOEC of the test substance for mortality, growth and feeding activity of the earthworm Eisenia fetida was determined to be 1000 mg/kg soil dw (highest tested conc), whereas the NOEC for reproduction was determined to be 500 mg/kg soil dw.

Executive summary:

A study was conducted to evaluate the chronic toxicity of the test substance, C12-18 DAQ (99.6% active) to adult Eisenia fetida, according to OECD guideline 222 and ISO 11268-2 in compliance with GLP. Adult earthworm (Eisenia fetida), with clitellum and weight range 300 to 599 mg and 9 to 10 m old from in-house culture was used in the study. Ten adult earthworm per replicate were allocated to an artificial soil containing 62.5, 125, 250, 500 and 1000 mg a.i./kg soil dw (nominal concentrations) for 56 days. No analytical dose verification was performed. Assessment of adult worm mortality, behavioural effects and biomass development was carried out after 28 d exposure of adult worms in treated artificial soil. Reproduction rate (number of offspring) was assessed after additional 28 d (assessed 56 d after application). No mortality was observed in any treatment group, except at the control, where one worm died. The body weight change of the earthworms after 4 weeks exposure to test material was not statistically significantly different compared to the control up to and including the highest test concentration of 1000 mg test material/kg soil dw. The reproduction rates were not significantly different compared to the control up to and including the test concentration of 500 mg test material/kg dry soil. At the highest test concentration of 1000 mg/kg soil dw the reproduction was significantly reduced compared to the control. No behavioural abnormalities were observed in any of the treatment groups. The feeding activity in all the treated groups was comparable to the control. Under the study conditions, the NOEC of the test substance for mortality, growth and feeding activity of the earthworm Eisenia fetida was determined to be 1000 mg/kg soil dw (highest tested conc), whereas the NOEC for reproduction was determined to be 500 mg/kg soil dw (Witte, 2010).