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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.