Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 940-005-3 | 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:
- 22 Oct 2013 to 28 Nov 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with OECD test guideline 423 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of Saccharose, Glycerine, biodiesel propoxylated
- EC Number:
- 940-005-3
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction product of Saccharose, Glycerine, biodiesel propoxylated
- Test material form:
- other: liquid
- Details on test material:
- Color of test item: red to brown, clear
Test item No.: 13/0453-1
Batch identification: T41/012/13
Purity: 100% UVCB
Homogeneity: The test item was homogeneous by visual inspection. Additionally, the homogeneity of the test item was ensured after shaking the test item container.
Storage conditions: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Strain: Crl:Wl (Han) SPF
Supplier: Charles River Wiga GmbH, Sulzfeld, Germany
Age on day 0: Young adult animals (female animals approx. 10 weeks)
Sex: Nulliparous and non-pregnant female animals were used for the test as suggested by the OECD guideline when there is no indication that male animals are likely to be more sensitive to the acute effects of the test item.
Arrival in the testing facility: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Body weight on day 0: Animals of comparable weight (± 20% of the mean weight)
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ±
3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Air changes per hour: approx. 10
Day/night rhythm: 12 h/12 h
Housing: Makrolon cages (type III), single housing
Diet: The animals received a VRF1(P) diet (SDS Special Diets Services, Altrip, Germany) and tap water ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Feed was withdrawn from the animals at least 16 hours before administration. The administration volume was 1.89 ml/kg bw.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The test item was administered to 2 test groups of 3 fasted rats each.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No clinical signs were observed during clinical examination
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).
Any other information on results incl. tables
Table 1. Effects on body weight.
Individual body weight changes | ||||||||||
Dose (mg/kg bw): | 2000 | 2000 | ||||||||
Administration: | 1 | 2 |
||||||||
Animal No.: | R948 | R949 | R950 | Mean weight | Standard-deviation | R960 | R961 | R962 | Mean weight | Standard-deviation |
Body weight at study day (g) | ||||||||||
0 | 180 | 182 | 183 | 181.7 | 1.53 | 188 | 185 | 185 | 186.0 | 1.73 |
7 | 199 | 203 | 204 | 202.0 | 2.65 | 213 | 197 | 205 | 205.0 | 8.00 |
14 | 210 | 208 | 214 | 210.7 | 3.06 | 217 | 206 | 223 | 213.3 | 8.62 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the median lethal dose of Reaction product of Saccharose, Glycerine, biodiesel propoxylated after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the undiluted test item Reaction product of Saccharose, Glycerine, biodiesel propoxylated were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females).
At 2000 mg/kg (first and second test group), no mortality occurred, and no clinical signs were observed. The mean body weight increased within the normal range throughout the study period with one exception in the second test group. One female showed
stagnation of body weight during the second week. There were no macroscopic pathological findings at the end of the observation
period.
The acute oral LD50 was calculated to be > 2000 mg/kg bw.
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.