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EC number: 940-422-0 | CAS number: -
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: other: clastogenicity/aneugenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-05 to 2013-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Glucamide CC
- IUPAC Name:
- Glucamide CC
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- EC Number:
- 940-422-0
- Cas Number:
- 1591783-13-9
- Molecular formula:
- C15H31NO6 (C8 derivative) C17H35NO6 (C10 derivative) C19H39NO6 (C12 derivative) C21H43NO6 (C14 derivative) C23H47NO6 (C16 derivative) C25H51NO6 (C18 derivative) C25H49NO6 (C18 unsatd. derivative)
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- Test material form:
- other: solid
- Details on test material:
- Name: Glucamide CC
Chemical Name: N-Cocoyl-N-methyl-glucamin
Physical State: solid
Density: 1.05 at 75°C
pH: 8-10
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: minimum 7 weeks
- Assigned to test groups randomly: yes
- Fasting period before study: 4h
- Housing: 5 animals of identical sex per cage, IVC cage (Polysulphone), Type II L
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice
- Water (ad libitum): tap water, sulphur acidified to pH value of approx. 2.8 (drinking water, municipal residue control, micro-biologically controlled at frequent intervals)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x per hour
- Photoperiod (hrs dark / hrs light): artificial light 6:00 - 18:00
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Solvent used: Aqua ad iniectabilia
- Justification for choice of solvent/vehicle: The solvent was chosenas suggested by the sponsor based on the test item`s characteristics.
- Concentration of test material in vehicle: 200 mg/mL (1 MTD), 100 mg/mL (0.5 MTD), 40 mg/mL (0.2 MTD)
- Amount of vehicle (if gavage or dermal): 10 mL per kg body weight
-Batch No.: 26210S1_2, AlleMan Pharma - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was weighed into a tared plastic vial on a precision balance.
The dose formulations were prepared by adding the required volume of Aqua ad iniectabilia and further short vortexing. Afterwards the test item-water mixture was heated to 40°C and vortexed again. After cooling to RT, the test item was applied to the animals. When crystallization occured, the test item-water mixture was again heated to 40°C and homogenized by vortexing.
The vehicle was selected as suggested by the sponsor based on the test item’s characteristics. The test item formulation was prepared freshly on each administration day before the administration procedure. The vehicle was also used as control item.
All animals received a single volume orally of 10 mL/kg bw. The solvent was chosen according to its relative non-toxicity for the animals. - Frequency of treatment:
- The animals received the test item once orally.
- Post exposure period:
- Sampling of the peripheral blood was carried out on animals 44 h (all control and dose groups) and 68 h (negative control, 1 MTD group) after treatment.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
three dose groups: 1 MTD (2000 mg/kg bw), 0.5 MTD (1000 mg/kg bw), 0.2 MTD (400 mg/kg bw)
Basis:
other: solution in Aqua ad iniectabilia
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control: clastogenic control substance, good stability at room temperature, broad basis of historical laboratory data
- Route of administration: intraperitoneal
- Doses / concentrations: 40 mg/kg body weight
Examinations
- Tissues and cell types examined:
- peripheral blood erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A preceding study on toxicity was performed with the same strain and under identical conditions as in the main study. Three animals of each sex were treated orally for detection of the maximum tolerable dose. The maximum dose that was applied was 2000 mg/kg bw according the OECD 474 guideline. The maximum volume which was administered was 10 mL/kg bw. The highest dose group evaluated in the main experiment (2000 mg/kg bw) was based on the toxicity observed in the pre-experiment.
METHOD OF ANALYSIS:
Evaluation of all samples, including those of positive and negative controls, was performed using a flow cytometer (FACScan, BD Biosciences). Anti-CD71 antibodies were labelled with Fluorescein-isothiocyanate (FITC), anti-CD61 antibodies were labelled with Phycoerythrin (PE). Particles were differentiated using Forward Scatter (FSC) and Side Scatter (SSC) parameters of the flow cytometer. Fluorescence intensity were recorded on the FL1, FL2 and FL3 channels for FITC, PE and PI respectively. At least 10000 immature erythrocytes per animal were scored for the incidence of micronucleated immature erythrocytes. To detect an eventually occurring cytotoxic effect of the test item the ratio between immature and mature erythrocytes was determined. The results were expressed as relative PCE (rel. PCE = proportion of polychromatic (immature) erythrocytes among total erythrocytes). - Evaluation criteria:
- There are several criteria for determining a positive result:
- dose-related increase in the number of micronucleated cells and/or
- biologically relevant increase in the number of micronucleated cells for at least one of the dose groups.
According to the OECD guideline, the biological relevance as well as the statistical significance of the results are the criterion for the interpretation.
A test item is considered to be negative if there is no biologically relevant and/or statistically significant increase in the number of micronucleated cells at any dose level. - Statistics:
- For the statistics the nonparametric Mann-Whitney Test was used. However, both biological relevance and statistical significance were considered together.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Clinical signs of toxicity in test animals:
In the pre-experiment a concentration of 200 mg/mL of the test item was evaluated. Three male and three female mice received a single dose of 2000 mg/kg bw orally and showed toxicity such as reduction of spontaneous activity, piloerection and half eyelid closure.
Due to the results obtained in the pre-experiment 2000 mg/kg bw was chosen as maximum tolerable dose (1 MTD) in the main experiment.
RESULTS OF DEFINITIVE STUDY
- Toxicity in the main experiment:
2000 mg/kg bw was tested as the maximum tolerable dose (1 MTD) in the main experiment. The volume administered was 10 mL/kg bw orally.
All animals treated with the highest dose (1 MTD) showed slight toxic effects. The animals treated with 1000 mg/kg bw (0.5 MTD) and 400 mg/kg bw (0.2 MTD) showed no toxic effects after the treatment with the test item.
- Induction of micronuclei (for Micronucleus assay):
The negative controls (44 h and 68 h) evaluated were within the range of the historical control data of the negative control (0.10 – 0.34%). The mean values of micronuclei observed for the negative control (44 h) were 0.23% (male mice) and 0.22% (female mice). The mean values for the 68 h negative control groups were 0.22% (male mice) and 0.23% (female mice).
The mean values of micronuclei observed after treatment with 0.2 MTD were 0.24% (male mice) and 0.27% (female mice). These values were within the range of the corresponding negative control and within the range of the historical negative control data.
The mean values noted for the 0.5 MTD dose group were 0.26% (male mice) and 0.24% (female mice). These values were within the range of the corresponding negative control and within the range of the historical negative control data.
The dose group treated with 1 MTD (44 h treatment) showed mean values of 0.31% (male mice) and 0.33% (female mice). The value observed in the male group was slightly above the range of the corresponding negative control, but within the range of the historical negative control data. The value observed in the female group was statistically significantly increased compared to the corresponding negative control. However this value was within the range of the historical negative control data.
The mean values observed for the 1 MTD 68 h treatment were 0.26% (male mice) and 0.29% (female mice). The value observed in the male group was within the range of the corresponding negative control and within the range of the historical negative control data. The value observed in the female group was statistically significantly increased compared to the corresponding negative control. However this value was within the range of the historical negative control data.
No biologically relevant increase of micronuclei was found after treatment with the test item in any of the dose groups evaluated.
- Ratio of PCE/NCE (for Micronucleus assay):
The negative controls (44 h, 68 h) were within the range of the historical control data of the negative control (1.19 - 4.30). The mean values noted for the 44 h negative control were 2.05 (male mice) and 1.32 (female mice). The mean values detected for the 68 h negative control were 3.14 (male mice) and 2.41 (female mice).
The animal group treated with 0.2 MTD showed mean values of the relative PCE of 2.21 (male mice) and 2.24 (female mice). The mean values observed in the male and in the female group were within the range of the historical negative control data. Moreover, in comparison to the corresponding negative control no statistically significant increases were observed.
The dose groups which were treated with 0.5 MTD showed mean values of the relative PCE of 2.45 (male mice) and 1.98 (female mice). The mean values observed in the male and in the female group were within the range of the historical negative control data. Moreover, in comparison to the corresponding negative control no statistically significant increases were observed.
The animals who received 1 MTD (44 h treatment) showed mean values of 2.04 (male mice) and 2.19 (female mice). The mean values observed in the male and in the female group were within the range of the historical negative control data. Moreover, in comparison to the corresponding negative control no statistically significant increase/decrease were observed
The animal group which was treated with 1 MTD (68 h treatment) showed mean values of the relative PCE of 1.75 (male mice) and 2.85 (female mice). The value observed in the male group was statistically significant decreased compared to the corresponding negative control. However, the values observed in the male and in the female group were within the range of the historical negative control data.
- Statistical evaluation:
The nonparametric Mann-Whitney Test was performed to verify the results. No statistically significant increases (p<0.05) of cells with micronuclei were noted in the dose groups of the test item evaluated, except the value observed for the 1 MTD female groups (44 h and 68 h). These groups were significantly increased as compared with the corresponding control. However the values were within the range of the historical negative control data. Based on this data these increases were regarded as not biologically relevant.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the study and under the experimental conditions reported, the test item Glucamide CC did not induce structural and/or numerical chromosomal damage in the immature erythrocytes of the mouse.
Therefore, the test item Glucamide CC is considered to be non-mutagenic with respect to clastogenicity and/or aneugenicity in the Mammalian Erythrocyte Micronucleus Test. - Executive summary:
In a NMRI mouse peripheral blood micronucleus assay, five male and female animals per dose group were treated orally with Glucamide CC at doses of 2000, 1000 and 400 mg/kg bw. Peripheral blood cells were harvested at 44 h (all dose and control groups) and 68 h (negative control and 1 MTD group) post-treatment. The vehicle was Aqua ad iniectabilia. The animals received the test item once orally.
Glucamide CC was tested at an adequate dose based on OECD 474. The positive control induced the appropriate response. There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in peripheral blood cells after any treatment time.
The animals treated with doses of 0.2 and 0.5 MTD showed no signs of systemic toxicity. The animals treated with a dose of 1 MTD showed slight signs of systemic toxicity such as reduction of spontaneous activity, catalepsis, piloerection, constricted abdomen and half eyelid closure.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 474 for in vivo cytogenetic mutagenicity data.
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