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EC number: 923-418-3 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 6 November 2007 - 27 August 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across froma acetalization product between glucose and C16/18(even numbered)alcohol. compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Except for absence of chemical analysis of the dosage forms
- Limit test:
- no
Test material
- Reference substance name:
- acetalization product between glucose and C16/18(even numbered)alcohol.
- IUPAC Name:
- acetalization product between glucose and C16/18(even numbered)alcohol.
- Details on test material:
- - Name of test material (as cited in study report): LCE07051
- Substance type: UVCB
- Physical state: white powder
- Analytical purity: not indicated
- Impurities (identity and concentrations): not indicated
- Composition of test material, percentage of components: not indicated
- Purity test date: not indicated
- Lot/batch No.: T70615
- Expiration date of the lot/batch: 7 February 2009
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature, protected from sunlight
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder
- Age at first treatment: approx. 7 weeks
- Weight at first treatment (mean): M=304 g, F=199 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Relative humidity: 50 ± 20%
- Light/dark cycle: 12h/12h
- Ventilation: 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: beginning: 19 November 2007 / end: 20 December 2007
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
test item heated to 80°C, mixed with vehicle heated to 80°C, forming a solution.
The test item dosage forms were prepared daily
VEHICLE
- Justification for use and choice of vehicle (if other than water): lipophilicity of the substance
- Concentration in vehicle: 10, 30 and 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg/day
- Lot/batch no. (if required): 057K6093
- Purity: not indicated - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Absence of a practical method of analysis
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day (m/f)
Basis:
other: nominal per gavage
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no serious effects at up to 1000 mg/kg/day in a 7-day range-finding study, see 7.5.1
- Rationale for animal assignment: computerized stratification procedure (average body weight of each group is similar)
- Post-exposure recovery period, satellite groups: not performed - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule: day 1 and then weekly
FOOD CONSUMPTION for each animal: Yes
- Time schedule: weekly (last 7-day consumption period)
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY and CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 23 to 26
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule: day 22
- Dose groups that were examined: all
- Battery of functions tested: behavior / reflexes / sensory activity / grip strength / motor activity / rectal temperature
REPRODUCTION/FERTILITY: Yes
- Vaginal smears for oestrous cycles: each morning from day 22
- Seminology: at sacrifice, on all males : epididymal sperm motility and morphology ; epididymal and testicular sperm counts - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all animals
ORGAN WEIGHTS: Yes, all animals
HISTOPATHOLOGY: Yes, all animals
all : see Table 1
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL CHEMISTRY
(Study director's opinion, see CSR author's opinion under "Effect levels") blood biochemistry analysis revealed higher triglycerides levels for male and female groups treated at 300 or 1000 mg/kg/day and higher urea and cholesterol levels for male and female groups treated at 1000 mg/kg/day.
SEMINOLOGY:
Epididymal sperm count and the percentage of morphologically normal sperm were lower for all groups treated with the test item and a slight effect was also observed on testicular sperm count. However since there were no treatment-related macroscopic or microscopic findings, and no dose-relationship, this was not considered unlikely to be test item-related by the study pathologist.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- set by study director
- Effect level:
- ca. 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Remarks:
- revised by CSR authors
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 2: Effects at blood biochemistry
Sex |
Male |
Female |
||||||
Dose-level (mg/kg/day) |
0 |
100 |
300 |
1000 |
0 |
100 |
300 |
1000 |
Urea (mmol/L) |
2.7 |
3.2 |
3.1 |
3.5* |
3.0 |
3.2 |
3.1 |
3.3 |
Cholesterol (mmol/L) |
1.8 |
1.9 |
2.0 |
2.1* |
1.5 |
1.6 |
1.5 |
1.9* |
Triglycerides (mmol/L) |
1.41 |
1.44 |
1.68 |
1.50 |
0.49 |
0.47 |
0.54 |
0.61 |
Table 3: Quantitative effects on sperm
Dose-level (mg/kg/day) |
0 |
100 |
300 |
1000 | ||||
Number of spermatozoa in cauda epididymis (M) | 120.0 | 81.5 | 80.2 | 85.4 | ||||
Number of spermatozoa per g of cauda of epididymis (M/g) | 441 | 346 | 319 | 375 | ||||
Percent motile epididymal sperm (%) | 96.7 | 93.3 | 91.6 | 92.3 | ||||
Number of sperm heads per g of testis (M/g) | 126.7 | 120.3 | 116.8 | 114.7 |
Table 4: Qualitative effects on sperm
Dose-level (mg/kg/day) |
0 |
100 |
300 |
1000 | ||||
Normal (%) | 93.8 | 86.5 | 86.6 | 90.6 | ||||
Normally shaped head separated from flagellum (%) | 3.0 | 9.5 | 7.4 | 3.6 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) was considered by the study director to be 100 mg/kg/day based on the blood biochemistry effects. The CSR authors upgraded it to 1000 mg/kg/day as the biochemical effects were either negligible and/or related to the expectable metabolism of the components of the UVCB (see CSR section 5.1: fatty acid metabolism).
- Executive summary:
The test item, LCE07051, was administered once daily by gavage to rats at the dose-levels of 100, 300 or 1000 mg/kg/day for 4 weeks.
No treatment-related effects were observed on mean body weight gain, food consumption, Funtional Observation Battery or hematology and no adverse clinical signs were recorded. There were no effects on female estrous cycles.
Cholesterol and triglycerides levels were increased in male and female groups treated at 300 and 1000 mg/kg/day and urea levels were also higher at 1000 mg/kg/day. These effects, being observed in both males and females, were considered to be treatment-related and adverse (Study director's opinion, see conclusion of CSR authors above).
Sperm analysis of the left testis and epididymis revealed a decreased epididymal sperm count and a lower percentage of morphologically normal sperm at all dose-levels. This could indicate an effect on epididymal maturation or testicular-epididymal transport although no effects were observed at microscopic examination of the right testis and epididymis and no effects were
observed on the organ weights. Particularly noticable in the epididymal sperm count was the homogeneity of the results among the males of each group and the fact that all the test item-treated males were affected. However the pathologist concluded : in view of the lack of relationship to dose, and the high incidence of unilateral spontaneous lesions in the testis and epididymis in this strain of rats, the decrease in sperm numbers was considered unlikely to be treatment-related.
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