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REACH

D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.

EC number: 940-284-1 | CAS number: 1591782-62-5

Life Cycle description
Uses advised against

Ecotoxicological information

Toxicity to terrestrial arthropods

Administrative data

Endpoint:: toxicity to terrestrial arthropods: short-term
Type of information:: experimental study
Adequacy of study:: key study
Study period:: 2014-10-21 to 2014-10-23
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: other: GLP study, no deficiencies

Data source

Reference

Reference Type:: study report
Title:: Unnamed
Year:: 2014
Report date:: 2014

Materials and methods

Test guideline

Qualifier:: according to guideline
Guideline:: OECD Guideline 213 (Honeybees, Acute Oral Toxicity Test)
Version / remarks:: OECD Guideline 214: Honeybees, Acute Contact Toxicity Test, September 1998
Deviations:: yes

Principles of method if other than guideline:: As winter bees were used, their exact age could not be determined.
GLP compliance:: yes
Application method:: other: oral and contact

Test material

Test material information

Test material form:: solid: particulate/powder
Remarks:: migrated information: powder
Details on test material:: - Physical state: Colourless powder
- Analytical purity: 93.9 % (w/w)
- Sum formula: C15H31NO6 (C8-Glucamide) C17H35NO6 (C10-Glucamide)
- Molecular weight:
C8-Glucamide: 321.42 g/Mol
C10-Glucamide 349.47 g/Mol
- Storage condition of test material: Room temperature, protected from light, in original container.

Sampling and analysis

Analytical monitoring:: no

Test substrate

Vehicle:: yes
Details on preparation and application of test substrate:: Solvents
Oral: Dispersion in 50 % aqueous sucrose solution
Contact: Dispersion in Tween 85 (1 %)

Test item dose
Oral:
The test item was administered in 200 µL per test cage. The nominal test item dose was 100 µg a.i./bee.

Contact:
One drop of 1 µL was applied to the dorsal thorax of each bee. The nominal test item dose was 100 µg a.i./bee.

Calculation steps,
oral mode
A stock solution of the test item of 100 µg a.i./bee was prepared. The test solution for the oral application was prepared as follows: 2.5 g household sugar was mixed with 2 mL dechlorinated tap water and 0.5 mL of dechlorinated tap water, the test item or reference item dilution, respectively. From this mixture, 200 µL were filled into the feeding tube of a cage.

Oral Mode: Calculation Steps for the Stock Solution, Test Item

Calculation step Dose
nominal test item dose/bee 100 µg a.i./bee
content of active substance: 93.9 % 106.50 µg product/bee
test item dose/10 bees 1064.96 µg product
in 0.2 mL sucrose solution
(feeding volume for 10 bees) 1064.96 µg product/0.2 mL
for 5 g sucrose solution at 50 % w/v
(density 1.227 g/mL, volume 4.07 mL) 21.672 mg product/4.07 mL
for 0.5 mL stock solution added to
2.0 mL tap water + 2.5 g sucrose 21.672 mg product/0.5 mL
prepared volume of stock solution:
10 mL (with dechlorinated tap water) 433.440 mg product/10 mL
Actual weight of test item 433.4 mg

Calculation steps,
Contact mode
A stock solution of the test item of 100 µg a.i./bee was prepared. 1 µL of the test item solutions were applied to the thorax of the bee.

Contact Mode: Calculation Steps for Stock Solution, Test Item
Calculation steps Dose
nominal test item dose/bee 100 µg a.i./1 µL
a.i./10 mL 1000 mg a.i./10 mL
direct weight of product
(content of active substance: 93.9 %) 1.0650 g product/10 mL (Tween 85, 1 %)
Actual weight of test item 1.0650 g

Application
Oral mode:
Bees share their food equally among themselves due to their reciprocal social feeding behaviour termed "trophallaxis". Therefore, the test item and reference substance amount for ten bees were applied to each cage containing ten animals (200 µL of a 50 % sucrose solution).

Contact mode:
Test item, control and reference item were applied onto the thorax of each bee individually with a micro piston pipette after paralysation with CO2 for about 20 seconds.
The application volume was 1 µL for the test item, the reference item and all controls.

Test organisms

Test organisms (species):: Apis mellifera
Animal group:: Hymenoptera (honeybees)
Details on test organisms:: TEST ORGANISM
- Common name: Apis mellifera L. (Hymenoptera, Apidae), subspecies A. m. carnica POLLM
- Source: Queen-right, healthy colony, provided by Ludwig Morsch, Nordstemmen. Only bees from the inside of the beehive were used for the study. No treatment against Varroa or other pests was applied in the 4 weeks prior to the study.
- Age at test initiation (mean and range, SD): As winter bees were used, their exact age could not be determined.
- Date of collection: The bees were collected from frames in the afternoon before application day.
- Cultural background (if honeybees):
- Disease free: yes
- Kept according to standard practices: yes

ACCLIMATION
- Acclimation period:
The bees were transferred immediately after collection to the laboratory and acclimatised to test conditions over night in a gauze-covered plastic bucket (oral and contact mode) and allowed to feed ad libitum (50 % sucrose solution and feeding paste (honey and sugar powder 1:1.5)).
- Acclimation conditions (same as test or not):
- Feeding:
- Health during acclimation (any mortality observed):

Study design

Study type:: laboratory study
Limit test:: yes
Total exposure duration:: 48 h

Test conditions

Test temperature:: Temperature
[°C]
nominal 23 - 27
actual
(both modes) 23 - 26
Humidity:: Relative humidity [%]
nominal 50-70
actual 45-67 1)
(both modes)
1) = Relative humidity decreased under 50 % for approx. 33 hours total time.
Photoperiod and lighting:: Photoperiod
nominal Continuous dark
actual Continuous dark
(both modes)
Details on test conditions:: TEST SYSTEM
- Test container / cage (material, size): Stainless steel cages, size 102 mm * 56 mm * 86 mm with holes punched into the bottom plate and a glass plate at front. The bottom was covered with a single layer of filter paper. The cages were fitted with two holes on the top, one for the introduction of the bees and one for placement of the feeding tube.
- Details of emergence and fecundity chambers:
- No. of organisms per container (treatment): 10 impartially chosen adult bees per cage
- No. of replicates per treatment group: Oral mode: 5 replicates for the test item, 4 replicates for the reference item, Contact mode: 5 replicates for the test item, 4 replicates for the reference item
- No. of replicates per per control / vehicle control: Oral mode: 5 replicates for the control, Contact mode: 5 replicates for the water and Tween (1 %) controls and 4 replicates for the and acetone control

EGG CULTURE CONDITIONS:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

FOOD CONSUMPTION (if oral study)
- Amount of treated diet consumed per group: 0.2 mL sucrose solution

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations:Limit Test
- Justification for using less concentrations than requested by guideline:
- Range finding study
Oral mode
Oral Mode: Mortality after 48 h (n = 30)
Control1) 0.1 1 10 100 Nominal test item dose [µg a.i./bee]
0.1 1.02 8.8 81.3 Actual test item dose [µg a.i./bee]
0 0 0 0 3.332) Mortality [%]
1) 50 % sucrose solution
2) A slight increase in the number of bees with abnormal behavioural effects
(slow movement, coordination disruption) could be observed compared to the control (< 20 %).

Contact mode
Contact mode: Mortality after 48 h (n = 30)
Control1) 0.1 1 10 100 Test item dose [µg a.i./bee]
0 0 6.67 0 02) Mortality [%]
1) Tween 85, 1 %
2) A slight increase in the number of bees with abnormal behavioural effects
(slow movement, coordination disruption) could be observed compared to the control (< 20 %).

- Test concentrations: 100 µg a.i./bee
- Results used to determine the conditions for the definitive study: see preliminary test
Reference substance (positive control):: yes
Remarks:: Danadim Progress

Results and discussion

Effect concentrationsopen all close all

Effect concentrations 1

Duration:: 24 h
Dose descriptor:: LD50
Effect conc.:: > 89 µg per animal
Nominal / measured:: nominal
Conc. based on:: act. ingr.
Basis for effect:: other: mortality, oral mode

Effect concentrations 2

Duration:: 48 h
Dose descriptor:: LD50
Effect conc.:: > 89 µg per animal
Nominal / measured:: nominal
Conc. based on:: act. ingr.
Basis for effect:: other: mortality, oral mode

Effect concentrations 3

Duration:: 24 h
Dose descriptor:: LD50
Effect conc.:: > 100 µg per animal
Nominal / measured:: nominal
Conc. based on:: act. ingr.
Basis for effect:: other: mortality, contact mode

Effect concentrations 4

Duration:: 48 h
Dose descriptor:: LD50
Effect conc.:: > 100 µg per animal
Nominal / measured:: nominal
Conc. based on:: act. ingr.
Basis for effect:: other: mortality, contact mode

Details on results:: - Mortality at end of exposure period:
Oral mode
Mortality and behaviour were determined after 4, 24 and 48 hours. The mortality in the sucrose control group was 2 % at test end.
The LD50 value of the test item, based on actual* test item doses was determined to be:
LD50, 24, 48 h value: > 89.0 µg a.i./bee*
* ) = Feeding rate was taken into account for evaluation.
Contact mode
The mortality and behaviour were determined at 4, 24 and 48 hours. Control mortality was 2.5 % (acetone), 0 % (Tween 85, 1 %) and 4 % (water) at test end.
The LD50 value of the test item, based on nominal test item doses was determined to be:

LD50, 24, 48 h value: > 100 µg a.i./bee

- Behavioural abnormalities: see Any other information on results incl. tables
Results with reference substance (positive control):: Oral mode

The LD50, 24 h value of the reference item, based on actual* test item doses was determined to be:

LD50, 24 h value: 0.101 µg a.i./bee (not determinable)

* ) = Feeding rate was taken into account for evaluation

Contact mode

The LD50, 24 h value of the reference item, based on nominal test item doses was determined to be:
LD50, 24 h value: 0.142 µg a.i./bee (CI: 0.124 - 0.169 µg a.i./bee)

CI = Confidence Interval
Reported statistics and error estimates:: Food uptake
The mean food uptake of control, test and reference item, the percentage of food uptake and the real consumed control, test and reference item was calculated. A suitable statistical procedure was used for comparison of food uptake of honey solution with test item versus honey solution control food uptake (see below) to determine possible repellent effects of the test item.

Correction of mortality rates Mortality rates of test item and reference item were corrected versus control according to formula 1 (SCHNEIDER-ORELLI 1947):

M = [(Mt - Mc) / (100 - Mc)] x 100 (1)

M = Corrected mortality [%]
Mt = Percentage mortality of the treated group
Mc = Percentage mortality of the control group

LD50 values
LD50 values of the reference item were calculated by sigmoidal dose-response regression. Calculation of the 95 % confidence intervals for the LD50 values was carried out using standard procedures.

STATISTICAL ANALYSIS
A t-test was used for comparison of food uptake of sucrose solution with test item versus control food uptake. When running the tests a Normality Test and an Equal Variance Test were done first. The P value for Normality Test is 0.194. The -value (acceptable probability of incorrectly concluding that there is a difference) is  = 0.05. The P value for Equal Variance Test is 0.704.