Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,6-anhydro-β-D-glucose
- EC Number:
- 207-855-0
- EC Name:
- 1,6-anhydro-β-D-glucose
- Cas Number:
- 498-07-7
- Molecular formula:
- C6H10O5
- IUPAC Name:
- (1R,2S,3S,4R,5R)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
- Reference substance name:
- Glycollaldehyde
- EC Number:
- 205-484-9
- EC Name:
- Glycollaldehyde
- Cas Number:
- 141-46-8
- Molecular formula:
- C2H4O2
- IUPAC Name:
- 2-hydroxyacetaldehyde
- Reference substance name:
- Organic acids
- IUPAC Name:
- Organic acids
- Reference substance name:
- Ketones
- IUPAC Name:
- Ketones
- Reference substance name:
- Phenols
- IUPAC Name:
- Phenols
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Oligomers of sugars and anhydrosugars
- IUPAC Name:
- Oligomers of sugars and anhydrosugars
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of Experimental Pharmacology and Toxicology, Center of Experimental Medicine of the Slovak Academy of Sciences, Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 222g, 220g, 219g, 189g, 195g, 190g
- Fasting period before study: Animals were fasted prior to dosing (food but not water was withheld over-night)
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air- conditioning.
- Diet (e.g. ad libitum): A standard laboratory food KKZ-P/M (UEFT CEM SAS) was available ad libitum.
- Water (e.g. ad libitum): The animals received tap water for human consumption. Supply of drinking water was unlimited.
- Acclimation period: The animals were acclimated to the condition identical to the condition during the experiment at least 5 days prior to the start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The room temperature was maintained within the range of 22±2 °C.
- Humidity (%): The relative humidity was 55±10 %.
- Photoperiod (hrs dark / hrs light): The light regime was set to a 12-hour light / 12-hour dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua Pro Injectione Bieffe
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg of the test item/4 mL
- Amount of vehicle (if gavage): 4 ml
- Justification for choice of vehicle: Ultra pure water such as API is a common vehicle for water soluble items in toxicity studies like OECD TG 423
CLASS METHOD
- Rationale for the selection of the starting dose: Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg of BTG Pyrolytic Sugar per kg body weight to be used as a starting dose. - Doses:
- Single dose of 2000 mg/kg body weight mixed with 4ml of the vehicle.
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2 and 4 hours later. Each animal was inspected daily for the next 14 days.
- Frequency of observations and weighing: Individual weights of animals were determined shortly before the test item administration and weekly thereafter.
- Observations included: Changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behavioural patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: All test animals were subjected to gross necropsy.
- Other examinations performed: External body surface and orifices, the appearance of tissues and organs in the thoracic cavity (trachea, esophagus, heart, aorta, lungs with main stem bronchi, thymus, tracheobronchial lymph node) and in the abdominal cavity (liver, spleen, adrenal glands, kidneys, ovaries, uterus including cervix, urinary bladder, small intestine, large intestine, pancreas, stomach, mesenteric lymph nodes). - Statistics:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- other: Mortality
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
- Gross pathology:
- No visible pathological findings were observed
Any other information on results incl. tables
Summary results of body weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 – Week 1 |
|||
Female |
2000 mg/kg |
1 |
222 |
238 |
244 |
16 |
22 |
6 |
2 |
220 |
231 |
235 |
11 |
15 |
4 |
||
3 |
219 |
231 |
235 |
12 |
16 |
4 |
||
4 |
189 |
224 |
227 |
35 |
38 |
3 |
||
5 |
195 |
227 |
247 |
32 |
52 |
20 |
||
6 |
190 |
223 |
230 |
33 |
40 |
7 |
Necropsy Results
Sex |
Dose |
ID |
Result |
Female |
2000 mg/kg |
1 |
no findings |
2 |
no findings |
||
3 |
no findings |
||
4 |
no findings |
||
5 |
no findings |
||
6 |
no findings |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
- Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. The test item at this dose did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level. It did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. During necropsy it was not observed any macroscopic findings in any of the animals.It was concluded that the LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
