Registration Dossier
Registration Dossier
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EC number: 270-337-8 | CAS number: 68425-17-2
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 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:
- no guideline followed
- Principles of method if other than guideline:
- Groups of rats were injected intraperitoneally with a single dose of Lycasin® 80/55 (50% dry weight) at a dose volume of 26 mL/kg body weight.
- 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: Liquid (clear, colorless)
- Analytical purity: 50% dry weight (originally 75% Lycasin® 80/55 was tested but after dilution with water, Lycasin® 80/55 was injected at 50% dry weight)
- Composition of test material, percentage of components: D-sorbitol (6 to 8%); hydrogenated disaccharides (50 to 55%); from tri to hexasaccharides hydrogenated (20 to 25%); hydrogenated saccharides higher than hexa (15 to 20%)
- Lot/batch No.: 1773
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Doses:
- 13 g/kg body weight [based on dry weight of Lycasin® 80/55]
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: LD50 could not be determined.
- Remarks on result:
- other: No mortalities were reported during the study period.
Any other information on results incl. tables
A significant reduction in weight gain was observed in animals which had received Lycasin® when compared to concurrent control group on Day 3 for male rats and on Days 3 and 7 for female rats. The weight changes of the animals which had received Lycasin® is otherwise comparable in the two groups from Day 7 to Day 14 for male rats and from Day 10 to Day 14 for female rats. There were no other particular clinical signs observed during the 14 days of the study.
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.
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.
