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Ecotoxicological information

Toxicity to terrestrial arthropods

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Endpoint:
toxicity to terrestrial arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 - 23 Jul 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 214 (Honeybees, Acute Contact Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Application method:
contact
Analytical monitoring:
no
Vehicle:
yes
Remarks:
Acetone
Details on preparation and application of test substrate:
- Method of test material application:
- Body part: dorsal bee thorax
- Volume of test solution applied: 5 µL droplet of AE 0001789 00 1C97 0005 in solvent
- Controls: yes, for the controls one 5 µL droplet of tap water with 1 % Adhasit was used (The Adhasit was used to improve the adhesion of the droplet on the bee body. Adhasit is non-toxic to honey bees.)
- Chemical name of vehicle: Acetone
- other: A 5 µL droplet was chosen in deviation to the guideline recommendation of a 1 µL droplet, since a higher volume ensured a more reliable dispersion of the test item; Ibacon experience has proven that higher volumes are suitable and no adverse effects on the outcome of the study are to be expected; [presented as a poster on the ICPBR Bee Protection Group meeting in Bologna, 2002]).
Test organisms (species):
Apis mellifera
Animal group:
Hymenoptera (honeybees)
Details on test organisms:
TEST ORGANISM
- Common name: worker honey bees
- Source: honey bee colonies, disease-free and queen-right, bred by IBACON
- Age at test initiation: 4 - 6 week old female bees
- Disease free: yes
- Kept according to standard practices: yes
- other: collected with glass tubes, from the outer honeycombs (away from the brood) without the use of smoke and without anaesthetics, collected in the morning of use.
Study type:
laboratory study
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
25 °C
pH (if soil or dung study):
-
Humidity:
54-70 %
Photoperiod and lighting:
darkness (except during observation)
Details on test conditions:
TEST SYSTEM
- Test container / cage (material, size): stainless steel cages, 10 cm x 8.5 cm x 5.5 cm (length x width x height)
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 5
- No. of replicates per per control / vehicle control: 5
- Anaesthetization: bees were anaesthetized with CO2 (only in the contact test)

OTHER TEST CONDITIONS
- Photoperiod: darkness (except during observation)
- Ventilation: ventilation to avoid possible accumulation of pesticide vapour

EFFECT PARAMETERS MEASURED
Mortality (number of dead bees after 4 hours (first day); 24 and 48 hours) and behavioural abnormalities ((vomiting, apathy, intensive cleaning) after 4 hours (first day) at 24 and 48 hours).

VEHICLE CONTROL PERFORMED: yes
Nominal and measured concentrations:
Nominal Dosage of the Test Item in the Contact Test and Oral Test: 100.0 µg of the a.i. of substance/bee
Reference substance (positive control):
yes
Remarks:
Perfekthion EC (BAS 152 11 I) [Dimethoate]
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 µg per animal
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Results with reference substance (positive control):
See "Any other information on results incl. tables".

Behavioural Abnormalities: no behavioural abnormalities attributed to exposure of the test item to the bees occurred during the experimental time of 48 hours.

Test Item Contact LD50: since no mortality occurred in the 100.0 µg a.i./bee group, the contact LD50 must be considered as > 100.0 µg a.i./bee.

Mortality (48 hours after application):

Test item:

100.0 ug a.i./bee: 0 of 50 bees (0.0%)

Control:

CO2/water control: 0 of 50 bees (0.0%)

CO2/acetone control: 0 of 50 bees (0.0%)

Toxic Standard:

0.30 µg a.i./bee: 50 of 50 bees (100.0%)

0.20 µg a.i./bee: 50 of 50 bees (100.0%)

0.15 µg a.i./bee: 37 of 50 bees (100.0%)

0.10 µg a.i./bee: 8 of 50 bees (100.0%)

Table 1: Validity criteria for OECD 214 (1998)

Criterion from the guideline

Outcome

Validity criterion fulfilled

The average mortality for the total number of controls must not exceed 10% at the end of the test.

The average mortality for the total number of controls was 0% at the end of the test.

yes

The LD50 of the toxic standard meets the specified range (0.10 – 0.30 µg a.i./bee, 24 h).

The LD50 of the toxic standard was 0.15 µg a.i./bee (24 h).

yes

 

Validity criteria fulfilled:
yes
Remarks:
See Table 1 in "Any other information on results incl. tables".
Endpoint:
toxicity to terrestrial arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 - 23 Jul 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 213 (Honeybees, Acute Oral Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Application method:
oral
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
Acetone
Details on preparation and application of test substrate:
- Details of food source: test substance or toxic standard dilutions in acetone were mixed with syrup in order to receive a relation of 1 part solvent solution +19 parts syrup. For the control, the same portion of syrup and acetone/water was used.
- Method of feeding during study: The diet was offered in syringes which were weighed before and after introduction into the cages (after max. 3.5 hrs the test item treated food was completely ingested by the bees and afterwards replaced by fresh, untreated food).
- Chemical name of vehicle: Acetone
- Concentration of vehicle in test medium: The use of a concentration of 5 % solvent was essential, to obtain the maximum dose rate of 100 µg a.i./bee. This deviation to the guideline, which recommends a volume of 1%, did not affect the outcome of the study.
Test organisms (species):
Apis mellifera
Animal group:
Hymenoptera (honeybees)
Details on test organisms:
TEST ORGANISM
- Common name: worker honey bees
- Source: honey bee colonies, disease-free and queen-right, bred by IBACON
- Age at test initiation (mean and range, SD): 4 - 6 week old female bees
- Disease free: yes
- Kept according to standard practices: yes
- other: collected with glass tubes, from the outer honeycombs (away from the brood) without the use of smoke and without anaesthetics, collected in the morning of use.
Study type:
laboratory study
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
25 °C
pH (if soil or dung study):
-
Humidity:
54-70 %
Photoperiod and lighting:
darkness (except during observation)
Details on test conditions:
TEST SYSTEM
- Test container / cage (material, size): stainless steel cages, 10 cm x 8.5 cm x 5.5 cm (length x width x height)
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 5
- No. of replicates per per control / vehicle control: 5
- Starvation Time: 15 minutes (only in the oral test)

EFFECT PARAMETERS MEASURED
Mortality (number of dead bees after 4 hours (first day); 24 and 48 hours) and behavioural abnormalities ((vomiting, apathy, intensive cleaning) after 4 hours (first day) at 24 and 48 hours).

VEHICLE CONTROL PERFORMED: yes
Nominal and measured concentrations:
Nominal Dosage of the Test Item in the Contact Test and Oral Test: 100.0 µg of the a.i. of test substance/bee
Measured Dosage of the Test Item in the Oral Test: 101.4 µg of the a.i. of test substance/bee
Measured Dosages of the toxic standard in the Oral Test: 0.27, 0.15, 0.08 and 0.04 µg Dimethoate per bee (oral test)
Reference substance (positive control):
yes
Remarks:
Perfekthion EC (BAS 152 11 I) [Dimethoate]
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 101.4 µg per animal
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Results with reference substance (positive control):
See "Any other information on results incl. tables".

Behavioural Abnormalities: no test item related behavioural abnormalities occurred

Test Item Oral LD50: since no mortality occurred in the 101.4 ug a.i./bee group, the oral LD50 must be considered as > 101.4 ug a.i./bee.

Results:

Test Item

 

101.4 ug a.i./bee:

0 of 50 bees (0.0%)

Control

 

water/sugar control:

0 of 50 bees (0.0%)

solvent control:

0 of 50 bees (0.0%)

Toxic Standard

 

0.27 ug a.i./bee:

0.15 p,g a.i./bee:

0.08 ug a.i./bee:

0.04 ug a.i./bee:

47 of 50 bees (94.0%)

21 of 50 bees (42.0%)

3 of 50 bees (6.0%)

0 of 50 bees (0.0%)

Table 1: Validity criteria for OECD 213 (1998)

Criterion from the guideline

Outcome

Validity criterion fulfilled

The average mortality for the total number of controls must not exceed 10% at the end of the test.

The average mortality for the total number of controls was 0% at the end of the test.

yes

The LD50 of the toxic standard meets the specified range (0.10 – 0.35 µg a.i./bee, 24 h).

The LD50 of the toxic standard was 0.18 µg a.i./bee (24 h).

yes

 

Validity criteria fulfilled:
yes
Remarks:
See Table 1 in "Any other information on results incl. tables".

Description of key information

LC50 (48 h): >100 µg a.i./bee (nominal, Hymenoptera, OECD 214)

 

LC50 (48 h): >101.4 µg a.i./bee (measured, Hymenoptera, OECD 213)

Key value for chemical safety assessment

Additional information

Two acute GLP-studies with honeybees are available according to OECD 214 and 213 (M-262568, M-262568-01-1). The limit tests were conducted with a test concentration of 100 µg a.i. per bee for the contact test and 100 µg a.i. per bee for the oral test. No lethal or sublethal effects on bees were observed in comparison to the control bees in the contact and oral toxicity test after an exposure period of 48 hours. Therefore it is concluded that the LD50 (48 h) is >100.0 µg a.i. per bee (nominal) in the contact toxicity test and >101.4 µg a.i. per bee (measured) in the oral toxicity test.