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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No rough data are included (calculated LD values only). No data on number of animals tested per concentration. No details on clinical signs or gross pathology. The test was performed in mice. Observation time limited to 10 days.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male and female mice were exposed to three different concentration of the test substance and observed for at least ten days.
GLP compliance:
no
Test type:
other: no details on study design
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridoxine hydrochloride
EC Number:
200-386-2
EC Name:
Pyridoxine hydrochloride
Cas Number:
58-56-0
Molecular formula:
C8H11NO3.ClH
IUPAC Name:
4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol hydrochloride
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Pyridoxine hydrochloride
- Lot No.: 258001, 258002, 258241, 248242, 258409, 258410, 258464, 258505, 258506, 258732

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 18-22 g

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on oral exposure:
Animals were observed for at least 10 days.
Doses:
3500, 7000 and 14000 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Ten batches were tested.
Statistics:
OLIVETTI calculator was used to detrmine LD values.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 6 994 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 10 day observation period; calculated value
Sex:
male/female
Dose descriptor:
LD0
Effect level:
3 344 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 10 day observation period
Mortality:
One animals died within 24 hours, some animals died after the first 24 hours but within the observation time of 10 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of ten batches of pyridoxine-hydrochlorid was tested in mice. After 10 days observation period, the LD0 was found to be 3344 mg/kg bw. The LD50 was calculated based on results of 10 batches and found to be 6994 mg/ kg bw.