Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Only few data on test method reported.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

GLP compliance:
not specified
Test type:
other: Writhing test
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyanocobalamin
EC Number:
200-680-0
EC Name:
Cyanocobalamin
Cas Number:
68-19-9
Molecular formula:
C63H88CoN14O14P
IUPAC Name:
cyanocobalamin
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Cyanocobalamin

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Vesuchstierzucht, Hagemann GmbH & Co, Extertal, FRG.
- Weight at study initiation: 21-28g.
- Diet (e.g. ad libitum): standard mouse diet, ad libitum.
- Water (e.g. ad libitum): ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: hydroxypropyl methylcellulose gel.
Details on oral exposure:
DOSAGE PREPARATION
The test compound was suspended in 0.8% aqueous hydroxypropyl methylcellulose gel.
The test substance was given alone or in combination at a ratio of 1:1:0.0025 for thiamine, pyridoxine, and cyanocobalamin.
Doses:
Not determined
No. of animals per sex per dose:
Groups of 5 animals
Control animals:
yes
Statistics:
A Kruskal-Wallis one-way analysis of variance in conjunction with a Wilcoxon two-sample test was used for the statistical analysis.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (maximum tolerated dose)
Mortality:
No mortality was observed for cyanocobalamine given alone or in combination up to a dose level of 5000 mg/kg bw.
Clinical signs:
other: No toxic effects were observed for cyanocobalamine given alone or in combination up to a dose level of 5000 mg/kg bw.

Any other information on results incl. tables

Following repeated oral administration for 7 days cyanocobalamin alone exerted a slight antinociceptive effect at 5620 mg/kg bw p.o.

The number of writhing reactions was reduced by 18% compared to the control.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No toxic effects were observed for the test substance up to a dose level of 5000 mg/kg bw/day.
Executive summary:

In the present acute oral toxicity study, the maximum tolerated dose was determined for cyanocobalamin. The test substance was given alone or in combination at a ratio of 1:1:0.0025 for thiamine, pyridoxine, and cyanocobalamin, to female mice. No toxic effects were observed for the test substance given alone or in combination up to a dose level of 5000 mg/kg bw/day.