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Toxicological information

Acute Toxicity: other routes

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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:
1982
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
Name:
Unnamed
Type:
Constituent
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

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