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Diss Factsheets

Administrative data

Description of key information

Company data and peer-reviewed literature do not indicate oral and dermal toxicity of pyridoxine-hydrochloride below 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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.
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
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
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.
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.
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.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data derived from peer-reviwed handbook.
Principles of method if other than guideline:
No details are given on test protocol.
GLP compliance:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 000 mg/kg bw
Based on:
test mat.

Other data in this handbook:

rat- scu LD50 = 3000 mg/kg

rat- ivn LD50 = 530 mg/kg

mouse- oral LD50 = 5500 mg/kg bw

mouse- scu LD50 = 2450 mg/ kg

mouse- ivn LD50 = 660 mg/ kg

cat- scu LDL0 = 1000 mg/ kg

cat- ivn LD50 = 560 mg/ kg

cat- ims LD50 = 500 mg/ kg

rabbit- ivn LD50 = 464 mg/ kg

Conclusions:
In peer-reviewed literature, the LD50 for acute oral toxicity of the test substance in rat was found to be 4000 mg/kg bw and in mice 5500 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No details on test substance (Lot, purity), no details on test protocol (number of animals, doses tested). Observation time limited to 10 days.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Ten different batches of the test substance were tested in 3 concentrations. Animals were observed for at least 10 days.
GLP compliance:
no
Test type:
other: no details on study design
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Details on study design:
Observation period was ten days
Sex:
not specified
Dose descriptor:
LD50
Effect level:
7 750 mg/kg bw
Based on:
test mat.
95% CL:
> 6 600 - < 8 900
Remarks on result:
other: 10 days observation, calculated value
Sex:
not specified
Dose descriptor:
other: LD10
Effect level:
4 940 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 10 days observation, calculated value
Sex:
not specified
Dose descriptor:
other: LD90
Effect level:
12 160 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 10 days observation, calculated value
Mortality:
Some animals died within 24 hours, some animals died after the first 24 hours but within the observation time of 10 days.
Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The oral toxicity of pyridoxine-hydrochloride was tested in rats. As the LD10 after 10 days was found to be 4940 mg/ kg bw, the test substance is not classified for oral toxicity.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Company data is available on the acute oral toxicity of the test substance in rat and mouse (Klimisch 2). Furthermore, data from peer-reviewed literature source is available.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The oral toxicity of pyridoxine-hydrochloride was tested in rats.The LD10 after 10 days was found to be 4940 mg/ kg bw. 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. In peer-reviewed literature, the LD50 for acute oral toxicity of the test substance in rat was found to be 4000 mg/kg bw and in mice 5500 mg/kg bw.

The acute dermal toxicity test is not a data requirement for Annex VII. Moreover, according to Competent Authorities for REACH and CLP (CARACAL) agreement to amend REACH Annex VIII (point 8.5.3) to waive this endpoint for substances that have not shown oral acute toxicity up to a limit dose of 2000 mg/kg bw in absence of indications that dermal adsorption exceeds oral adorption. Furthermore, data from peer-reviewed literature source report an LD50 of 2450 mg/ kg in mice.


Justification for selection of acute toxicity – oral endpoint
No single study was selected, endpoint conclusion derived based on weight-of-evidence.

Justification for classification or non-classification

As the available data do not indicate toxic effects after single exposure, pyridoxine-hydrochloride is not classified for acute toxicity according to Regulation (EC) No 1272/2008.