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EC number: 940-284-1 | CAS number: 1591782-62-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 014
- 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
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 940-284-1
- Cas Number:
- 1591782-62-5
- Molecular formula:
- C15H31NO6 C17H35NO6
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Reference substance name:
- Glucamide 810
- IUPAC Name:
- Glucamide 810
- 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.
Constituent 1
Constituent 2
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 allclose all
- 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
- 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
- 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
- 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.
Any other information on results incl. tables
Oral Mode: Mortality and Behaviour in the Sucrose Control Group after 4, 24 and 48 hours
Time after start of application |
Behaviour |
Replicate |
||||
1 |
2 |
3 |
4 |
5 |
||
4 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
24 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
48 h |
T |
- - 10 / 10 |
- - 10 / 10 |
1 / 10 - 9 / 10 |
- 1 / 10 9 / 10 |
- 1 / 10 9 / 10 |
T = dead
L = slow movements / coordination problems
N = normal (no abnormality observed
-) = no occurence
Oral Mode: Mortality and Behaviour in the Test Item Group 100 µg a.i./bee after 4, 24 and 48 hours
Time after start of application |
Behaviour |
Replicate |
||||
1 |
2 |
3 |
4 |
5 |
||
4 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
24 h |
L |
- 10 / 10 |
- 10 / 10 |
3 / 10 7 / 10 |
- 10 / 10 |
4 / 10 6 / 10 |
48 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
L = slow movements / coordination problems
N = normal (no abnormality observed)
-) = no occurence
Contact Mode: Mortality and Behaviour in the Water Control Group after 4, 24 and 48 hours
Time after start of application |
Behaviour |
Replicate |
||||
1 |
2 |
3 |
4 |
5 |
||
4 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
24 h |
L |
1 / 10 9 / 10 |
- 10 / 10 |
- 10 / 10 |
- 10 / 10 |
- 10 / 10 |
48 h |
T |
2 / 10 - 8 / 10 |
- 1 / 10 9 / 10 |
- - 10 / 10 |
- - 10 / 10 |
- - 10 / 10 |
T = dead
L = slow movements / coordination problems
N = normal (no abnormality observed)
-) = no occurrence
Contact Mode: Mortality and Behaviour in theTween 85 (1%) Control Group after 4, 24 and 48 hours
Time after start of application |
Behaviour |
Replicate |
||||
1 |
2 |
3 |
4 |
5 |
||
4 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
24 h |
L |
- 10 / 10 |
2 / 10 8 / 10 |
- 10 / 10 |
1 / 10 9 / 10 |
- 10 / 10 |
48 h |
L |
- 10 / 10 |
- 10 / 10 |
- 10 / 10 |
1 / 10 9 / 10 |
- 10 / 10 |
L = slow movements / coordination problems
N = normal (no abnormality observed)
-) = no occurrence
Contact Mode: Mortality and Behaviour in the Acetone Control Group after 4, 24 and 48 hours
Time after start of application |
Behaviour |
Replicate |
|||
1 |
2 |
3 |
4 |
||
4 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
24 h |
T |
- 1 / 10 9 / 10 |
- - 10 / 10 |
1 / 10 5 / 10 4 / 10 |
- - 10 / 10 |
T = dead
L = slow movements / coordination problems
N = normal (no abnormality observed)
-) = no occurrence
Contact Mode: Mortality and Behaviour in the Test Item Group 100 µg a.i./bee after 4, 24 and 48 hours
Time after start of application |
Behaviour |
Replicate |
||||
1 |
2 |
3 |
4 |
5 |
||
4 h |
N |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
10 / 10 |
24 h |
T |
- - 10 / 10 |
- 1 / 10 9 / 10 |
1 / 10 - 9 / 10 |
- - 10 / 10 |
- - 10 / 10 |
48 h |
T |
- 1 / 10 9 / 10 |
- 1 / 10 9 / 10 |
1 / 10 - 9 / 10 |
- - 10 / 10 |
- - 10 / 10 |
T = dead
L = slow movements / coordination problems
N = normal (no abnormality observed)
-) = no occurrenceApplicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The mean mortality of the control groups did not exceed 10 % at test end. Control mortality was 0 % (1 % Tween 85), 2 % (50 % sucrose solution), 2.5 % (acetone) and 4 % (water), respectively.
The LD50,24 h values of the reference item with 0.101 µg a.i./bee in the oral mode and 0.142 µg a.i./bee in the contact mode were within the required range of 0.10 - 0.35 µg a.i./bee (oral) and 0.10 - 0.30 µg a.i./bee (contact), respectively. - Executive summary:
The acute effects of C8/C10-Glucamide AC93/13 (batch No.AC93/13) on the Honeybee Apis mellifera (Hymenoptera, Apidae) were determined according to OECD 213/214 (1998) at Dr.U.Noack-Laboratorien, D-31157 Sarstedt, from 2014-10-21 to 2014-10-23 (oral and contact mode). In both test modes, a limit test with the nominal test item dose 100 µg a.i./bee was conducted. 5 replicates for the controls and test item and 4 replicates for the reference item in oral and contact mode, respectively, were tested, each containing 10 bees. In the oral mode, 50 % aqueous sucrose solution, in the contact mode, Tween 85 solution (1 %), acetone and water were used as controls. Danadim Progress (0.022 - 0.046 - 0.100 - 0.220 - 0.460 µg Dimethoate/bee - nominal doses in oral and contact mode) was used as a reference item. The mortality was assessed after 4, 24 and 48 hours exposure period in oral and contact modes. After 24 hours, the LD50value of the reference item treatment was 0.101 µg a.i./bee in oral mode (based on the actual references item doses) and 0.142 µg a.i./bee in contact mode (based on the nominal reference item doses). LD50values of C8/C10-Glucamide AC93/13 are summarised below.
The study is considered valid as the validity criteria were fulfilled.
Toxicity to Honeybees, Laboratory Tests
Test item
C8/C10-Glucamide AC93/13
Test organism
Apis mellifera
Exposure
Oral*)
Contact
LD5024 h
µg a.i./bee
> 89.0
> 100
LD5048 h
µg a.i./bee
> 89.0
> 100
*) = LD50value based on the actual test item doses (food uptake was taken into account)
a.i. = active ingredient, analytical value 93.9 % w/w, according to the certificate of analysis from 2013-09-03
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