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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
It is considered appropriate to address the data requirements for DTO_DETA by read-across to the available studies on the main components of DTO_DETA: AAI_DETA and Rosin.
DTO_DETA and AAI_DETA are each a mixture of constituents which include monoamide, diamide, residual amine and imidazoline (mono-, di- and tri-condensate) chemical structures. The substances therefore have common functional groups based on amide, amine and imidazoline moieties and are sufficiently similar in terms of chemical structure to support a read-across approach.
DTO_DETA contains comparatively lower levels of imidazolines and higher levels of resin acids than AAI_DETA and therefore consideration of data for resin acids is also considered necessary. The main resin acid in DTO_DETA is abietic acid, but abietic acid derivatives and other acids, such as pimaric acid, are also found in notable quantities, and the resin acids collectively are known as ‘rosin’. DTO_DETA contains upto 25% unreacted rosin, and taking into account the compositional information available for the rosin in DTO_DETA and Rosin (CAS# 8050-09-07, EC# 232-475-7), the latter was considered appropriate for read-across to DTO_DETA.
The AAI_DETA dataset is worst case with regards to biodegradability and aquatic toxicity, with the dataset for Rosin showing a lower toxicity profile. Therefore, AAI_DETA is considered to be a worst case read-across source for the DTO_DETA target substance in the context of short-term toxicity to aquatic invertebrates.
Reason / purpose for cross-reference:
read-across source
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
0.42 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 0.33-0.61 (95% CI)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.18 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 0.18-0.35 (95% CI)
Details on results:
The appearance of the test solutions was visually checked at the beginning and at the end of the test.
Solutions were found to be clear, colourless over the period of the test. No precipitation was observed at the end of the test.
Results with reference substance (positive control):
The nearest value of EC50 obtained on 31/05/2007 was 0.95 mg/L with potassium dichromate, which is within the ISO 6341 acceptable range of 0.6 to 2.1 mg/L .
Reported statistics and error estimates:
The EC50 values were calculated using Probit analysis in an Excel sheet. The NOEC was determined using the Dunnett's test.

Range find test: Percentage of Daphnia magna immobilisation

Nominal concentrations (mg/L)

Immobilisation (%)

24 h

48 h

0.05

0

0

0.5

10

100

1

100

100

5

100

100

10

100

100

50

100

100

Definitive test: Percentage of Daphnia magna immobilisation

Geometric mean concentrations (mg/L)

Immobilisation (%)

24 h

48 h

0

0

0

0.045

0

0

0.068

0

0

0.112

0

10

0.266

15

70

0.355

45

100

 0.608  75  100
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the target substance DTO_DETA to Daphnia magna is estimated to be a 48 h EC50 = 0.18 mg/L, based on read-across from a study testing AAI_DETA.
Executive summary:

The acute toxicity of the target substance DTO_DETA to Daphnia magna is estimated to be a 48 h EC50 = 0.18 mg/L, based on read-across from a study testing AAI_DETA.

As explained in the justification for type of information, DTO_DETA and AAI_DETA are each a mixture of constituents which include monoamide, diamide, residual amine and imidazoline (mono-, di- and tri-condensate) chemical structures. The substances therefore have common functional groups based on amide, amine and imidazoline moieties and are sufficiently similar in terms of chemical structure to support a read-across approach.

DTO_DETA contains comparatively lower levels of imidazolines and higher levels of resin acids than AAI_DETA and therefore consideration of data for resin acids is also considered necessary. The main resin acid in DTO_DETA is abietic acid, but abietic acid derivatives and other acids, such as pimaric acid, are also found in notable quantities, and the resin acids collectively are known as ‘rosin’. DTO_DETA contains upto 25% unreacted rosin, and taking into account the compositional information available for the rosin in DTO_DETA and Rosin (CAS# 8050-09-07, EC# 232-475-7), the latter was considered appropriate for read-across to DTO_DETA and relevant studies testing Rosin are included as separate supporting source records.

The AAI_DETA dataset is worst case with regards to biodegradability and aquatic toxicity, with the dataset for Rosin showing a lower toxicity profile. Therefore, AAI_DETA is considered to be a worst case read-across source for the DTO_DETA target substance in the context of short-term toxicity to aquatic invertebrates.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 24 2007 to May 5 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 202 guideline study, GLP, All validity criteria fulfilled, complete identification of test substance, including chemical analyses
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Guidance document on aquatic toxicity testing of difficult substances and mixtures. OECD Environmental Health and Safety Publication, Series on Safety testing and assessment, No. 23, Paris (December 2000)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Trade name: Imidazoline produced by reaction of Olein (Olein R210 ) and of the DETA (diethylene tetramine)
Batch number/supplier: PILOTE 27/07/06 - CECA
Date of reception in test facility: 31/07/06
Expiration date of test item: ---
Attributed GRL number: 0055/06

Main characteristics
-appearance: yellow thick liquid
-purity: 100%, cyclisation rate 50.2%
-water solubility: not miscible
-relative density: 950 kg/m3 at 25 deg celsius
-certificate of analysis reference: ---

Reference item
Chemical name: Potassium dichromate
CAS number: 7778-50-9
Date of reception in the test facility: 21/02/06
Expiration date of test item: 02/2011
Batch numbers supplier: 18703 HB/Aldrich

Reference item characteristics
Empirical formula: K2Cr2O7
Purity: >99.95 %
Molecular weight: 294.21 g/mol
Water solubility: 4.3% (20oC)
Analytical monitoring:
yes
Details on sampling:
Samples: 6
Storage of samples: none
Samples treatment: dilution in methanol with a dilution factor ranging from 2 to 10
Vehicle:
no
Details on test solutions:
Osmotically filtered water was used to prepare the dilution water, using analytical grade reagents.

Test solutions
A stock solution of IMIDAZOLE 4900 diluted in water was prepared at the beginning of the tes time (time 0) by mixing 10 mg of IMIDAZOLINE 4900 in one liter of dilution water. After 24h stirring, solution was filtered through HAWP04700 Millipore membrane to obtain limpid solutions.
Volumetric flasks were filled with the required volumes of this test item stock solution and dilution water was added in order to obtain the test solutions at different concentrations.
Test organisms (species):
Daphnia magna
Details on test organisms:
Biological reagent: organisms Daphnia magna Straus (Cladocera, Crustacea) clone 5 or clone A. Animals come from a stock breeding in the laboratory reared in VOLVIC water added with vitamin B12, Na2SeO3.5H2O, spirulline, calcium, magnesium, unicellular green freshwater algae Pseudokirchnerielle subcapitata and Chlorella vulgaris. Selection of test organisms less than 24 hours old is made by filtration.

The sensitivity of the test system and the methodology are evaluated every month by performing an inhibition test on potassium dichromate. The nearest value of EC50 obtained on 31/05/2007 was 0.95 mg/L. For reference, ISO 6341 has a validity criteria specifying that EC50 must be in the range of 0.6 to 2.1 mg/L
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
Preliminary test: 19.3 +- 1 deg celsius
Definitive test: 19.8 +- 1 deg celsius
pH:
7.98 to 8.15
Dissolved oxygen:
8.5 to 9.6 mg/L
Salinity:
not relevant for freshwater tests
Nominal and measured concentrations:
Preliminary test
Nominal: 0.05; 0.5; 1; 5; 10; 10; 50 mg/L
Measured (initial) 0.045; 0.426; 0.93; 4.27; 8.13; 48 mg/L
Measured (final) 0.02; 0.33; 0.73; 3.02; 5.34; 17.54 mg/L
Final/intial (%); 44.4; 77.5; 78.5; 70.7; 65.7; 36.5

Definitive test
Nominal: 0.048; 0.076; 0.122; 0.195; 0.313; 0.5 mg/L
Measured (initial) 0.051; 0.078; 0.157; 0.326; 0.433; 0.692 mg/L
Measured (final) 0.040; 0.060; 0.080; 0.217; 0.292; 0.535 mg/L
Geometric means 0.045; 0.068; 0.112; 0.266; 0.355; 0.608 mg/L
Details on test conditions:
The study was performed in a temperature controlled room using 30 ml glass bottles stoppered with PTFE bungs and sealed with aluminium caps. The temperature, continuously recorded in one test flask, remained near 20 deg. celsius.
Physico-chemical parameters were measured using a METTLER TOLEDO 345 pH meter for measurement of pH and with a WTW OXI 538 oxymeter for dissolved oxygen measurements.

Preliminary test
Daphnids were exposed to 6 concentrations under static conditions (50, 10, 5, 1, 0.5, 0.05 mg/L) of IMIDAZOLINE 4900 in dilution water. The toxic effect measured during the assay was the inhibition mobility over a time period of 48 hours.
Approximately 90% of the test volume of the test solution was added into the test flasks. 5 Daphnia magna aged from 6 to 24 hours were added into each test flask, which were then totally filled with the test solution (30ml). Two replicates were prepared for each test concentration. Two control flasks were prepared under the same conditions with no test item. Test flasks were incubated in darkness at a temperature of 19.3+- 1 deg. celsius.

Definitive test
Based on the results of the preliminary test, the concentrations tested were: 0.5; 0.313; 0.195; 0.122; 0.076; 0.048 mg/L. (geometric progression factor 1.6).
At the beginning of the test, appropriate volumes of the stock solution were poured directly into the test aquarium. They were then topped up with dilution waster to obtain the above mentioned range of nominal concentrations, with no pH adjustments.
Approximately 90% of the final volume of the test solution was added into test flasks. 5 Daphnia magna aged from 6 to 24 hours were added into each test flask, which were then totally filled with the test solution (30 ml). 4 replicates were prepared for each concentration. 4 control flasks were prepared under the same conditions, with no test item. Test flasks were incubated in darkness at a temperature of 19.8 +- 1 deg. celsius,
After 24 hours of incubation, mobile D. magna were counted and flasks replaced under incubation. at 48 hours the Daphnids were also counted.
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
0.42 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 0.33 - 0.61 (95% CI)
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.18 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 0.18 - 0.35 (95% CI)
Details on results:
The appearance of the test solutions was visually checked at the beginning and at the end of the test. Solutions were found to be clear, colourless over the period of the test. No precipitation was observed at the end of the test.
Results with reference substance (positive control):
The nearest value of EC50 obtained on 31/05/2007 was 0.95 mg/L with potassium dichromate, which is within the ISO 6341 acceptable range of 0.6 to 2.1 mg/L .
Reported statistics and error estimates:
The EC50 values were calculated using Probit analysis in an Excel sheet. The NOEC was determined using the Dunnett's test.

Range find test: Percentage of Daphnia magna immobilisation

Nominal concentrations (mg/L)

Immobilisation (%)

24 h

48 h

0.05

0

0

0.5

10

100

1

100

100

5

100

100

10

100

100

50

100

100

Definitive test: Percentage of Daphnia magna immobilisation

Geometric mean concentrations (mg/L)

Immobilisation (%)

24 h

48 h

0

0

0

0.045

0

0

0.068

0

0

0.112

0

10

0.266

15

70

0.355

45

100

 0.608  75  100
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of IMIDAZOLINE 4900 to Daphnia magna was assessed under static conditions according to the OECD 202 guideline, and resulted in the following EC50 values
24 h EC50 = 0.42 mg/L
48 h EC50 = 0.18 mg/L
Executive summary:

Summary

The acute toxicity (inhibition of mobility) of the test item IMIDAZOLINE 4900 for a duration of 48 hours was assessed according to the OECD guideline 202.

Daphnia magna were exposed under static conditions to a range of concentrations of IMIDAZOLINE 4900 dissolved in dilution water. The toxic effect measured during the assay was the inhibition of mobility time periods of 24 and 48 hours.

The concentration of test item causing a 50% reduction in mobility (EC50) was estimated.

The results were as follows:

Duration of exposure period (h)

EC50 value, mg/L (95% CI)

24

0.42 (0.33 – 0.61)

48

0.21 (0.1 – 0.35)

C.I.: confidence interval

The study was performed in compliance with the following criteria:

  • The immobilisation in the control did not exceed 10% at the end of the test;
  • Daphnids in the control were not trapped at the surface of the water;
  • The dissolved oxygen concentration remained above 3mg/L over the test period.

Description of key information

It is considered appropriate to address the data requirements for DTO_DETA by read-across to the available studies on the main components of DTO_DETA: AAI_DETA and Rosin.
    
    
    
    
    

The most conservative result for AAI_DETA indicates a 48 h EC50 of 0.18 mg/L. The most conservative result for Rosin indicates an EL50 of 10 mg/L.

The AAI_DETA dataset is worst case with regards to biodegradability and aquatic toxicity, with the dataset for Rosin showing a lower toxicity profile. Therefore, AAI_DETA is considered to be a worst case read-across source for the M102K target substance in the context of short-term toxicity to aquatic invertebrates. The acute toxicity of M102K to Daphnia magna is therefore estimated to be a 48 h EC50 of 0.18 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.18 mg/L

Additional information