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EC number: 270-337-8 | CAS number: 68425-17-2
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Version / remarks:
- -reliability scoring based on 1998 guideline
- Deviations:
- yes
- Remarks:
- -purity and source/origin of test article not provided; deviations continued in Materials and Method Section
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Syrups, corn, hydrogenated
- EC Number:
- 270-337-8
- EC Name:
- Syrups, corn, hydrogenated
- Cas Number:
- 68425-17-2
- Molecular formula:
- UVCB substance: not applicable
- IUPAC Name:
- Syrups, hydrolyzed starch, hydrogenated
- Details on test material:
- - Name of test material (as cited in study report): LYCASIN 80/55
- Physical state: Not reported
- Analytical purity: Not reported
- Lot/batch No.: 462B
- Stability under test conditions: Not reported
- Storage condition of test material: Cold room (4°C)
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CERM, 63201 RIOM, France
- Age at study initiation: 8 months (except for 1 dog, which was 6 months old).
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Animals were housed in 1.35 square meters wired boxes (2 animals of the same sex/box)
- Diet (e.g. ad libitum): Commercial compound granulated feeds
- Water (e.g. ad libitum): Adequate drinking water; ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.3 ± 1.2
- Humidity (%): relative humidity of 40 ± 20
- Air changes (per hr): 8 to 9
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: December 21, 1981 To: June 16, 1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Product was warmed up at 40°C just before each administration in order to reduce the viscosity.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Actual dose administered was reported as 4.95 g/kg bw; however, details on the analytical verification of the dose was not provided.
- Duration of treatment / exposure:
- 13 weeks (93 days)
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
4.95 g/kg body weight (4.87 mL/kg body weight)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
5.00 g/kg body weight (4.87 mL/kg body weight)
Basis:
other: nominal
- No. of animals per sex per dose:
- 4/sex/group
- Control animals:
- other: yes, treated concurrently with tap water
- Details on study design:
- - Dose selection rationale: Decision made by owner company
- Post-exposure recovery period in satellite groups: Animals were sacrificed after 13 weeks of treatment (no recovery period was tested). - Positive control:
- None used.
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily observations (diarrhea occurrence was recorded on a weekly basis)
BODY WEIGHT: No (only body weight gain data was provided)
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Weeks 0, 2, 4, 8, and 13
- Dose groups that were examined: all animals
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Weeks 0, 4, and 13
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Weeks 0, 4, and 13
- Animals fasted: No data
- How many animals: all animals
URINALYSIS: Yes
- Time schedule for collection of urine: Weeks 0, 4, and 13
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: Para aminohippurate (PAH) clearance was determined on all animals at the end of the study period. - Sacrifice and pathology:
- All of the animals were sacrificed at the end of the 13 weeks and macroscopic and microscopic examinations of various organs were evaluated.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
One animal was found dead on the 21st day with lesions of pneumonia. The authors reported that this death was due to incorrect intubation and not compound-related. No clinical symptoms appeared following the administration of Lycasin, except for intermittent diarrhea reported in all test animals. The onset of diarrhea was not related to the time of compound administration.
BODY WEIGHT AND WEIGHT GAIN
The control animals and the test animals had comparable growth. One female animal lost weight regularly in small amounts from the 8th week of treatment and had an increased serum triglyceride level, and an increased serum alkaline phosphatase level, which correlated with the presence of dark bile on autopsy.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The control animals received a normal food intake. Male dogs in the test group had their food intake reduced by 30% and all females had a normal food intake, except for 2 animals at the end of the study. Food intake in the test animals was slightly decreased throughout the entire study, without any effect on the animals’ weight progression.
OPHTHALMOSCOPIC EXAMINATION
Ophthalmologic examinations did not reveal any compound-related abnormalities.
HAEMATOLOGY
No hematological disturbances were reported to be related to the administration of Lycasin, except for increased erythropoiesis in 1 female animal in the test group. The increased erythropoiesis was suggested by the authors to be correlated with the tubular dilation of the nephron (stimulation of erythropoietin production).
CLINICAL CHEMISTRY
Biochemical laboratory tests revealed an increase in the level of circulating triglycerides in 3 female animals in the test group. This modification became abnormal for 1 female animal at 13 weeks. The authors suggested this animal was more sensitive than the other animals to the sugar-rich diet. The predominant oxidation of the glucids (glycolysis and krebs cycle) slowed down the oxidation of fatty acids resulting from lipolysis. Thus, the free fatty acids and those “formed” from glucids are reused for the synthesis of triglycerides. This animal also had a higher alkaline phosphatase level than the other animals, which correlated with the presence of dark bile upon autopsy. No biologically significant modification was reported for the other parameters.
URINALYSIS
Urinary analyses did not reveal any abnormalities related to the administration of the test compound.
ORGAN WEIGHTS
No significant compound-related changes in organ weight were reported.
GROSS PATHOLOGY
Following macroscopic examination, no compound-related abnormalities were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histological examinations revealed dilated kidney tubules (intensity was minimal) in 2 male dogs and 3 female dogs of the test group. Other lesions or abnormal findings are common and frequently observed in the beagle dog under the experimental conditions of the tests.
OTHER FINDINGS
Clearance determination of PAH did not show a decreased value.
Effect levels
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: The authors did not report a NOAEL.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
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