Pyridoxine hydrochloride

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Remarks:

other: 10 days

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1974

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No details on purity of test substance. No guideline followed. Parameters addressed limited to body weight and mortality. No control group included.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats and mice were exposed daily via oral gavage for ten days. Body weight was meassured on day 0, 5 and 11. Mortality was determined daily.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

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

Details on test material:

- Name of test material (as cited in study report): Pyridoxin-hydrochlorid
- Lot no.: Mag-No 1160, A/364462

Test animals

Species:

other: rat and mice

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 20 g (mice), 50 g (rats)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: gum arabic

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

10 days

Frequency of treatment:

Daily

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
2000, 4000, 8000 and 16000 mg/kg bw (mice)
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
500, 1000, 2000, 4000, 8000 and 16000 mg/kg bw (rats)
Basis:
actual ingested

No. of animals per sex per dose:

No data

Control animals:

no

Details on study design:

Observation period: 20 days (10 days observation after last dose)

Examinations

Observations and examinations performed and frequency:

Mortality was checked at least daily. Weight was determined on day 0, 5, 10 and 20.

Sacrifice and pathology:

No data.

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

Observations in mice:
No mortality was observed at 2000 mg/kg bw/ day. At 4000 mg/kg, mortality was 30% on day 2, 50% on day 3, and 60% on day 8 until the end of the observation period. At 8000 mg/kg bw, 10% of the mice died on day 1, all others on day 2. At the highest dose of 16000 mg/kg bw, no mice survived the first exposure.
On day 5and 10, the mice exposed to 4000 mg/kg bw/ day suffered body weight loss (- 12% and -17.5% resp.). The group exposed at 2000 mg/kg bw had a slight body weight increase compared to the start weight on both days (on average + 8% and 15.5% for days 5 and 10 resp.).

Observations in rats:
No rats survived 16000 mg/kg bw (100% mortality day 1) and 8000 mg/kg bw/ day (80% mortality day 1, 100% mortality day 2). At 4000 mg/kg bw/ day, 50% of the rats died on day 3, on day 4 and 5 mortality increased to 80% and 100%. At 2000 mg/kg bw/ day, 10% of the rats died on day 3, mortality on day 6 increased to 60%, and on day 7 to 80%. No rats survived more than 8 days exposure to 2000 mg/kg bw/ day. At 1000 mg/kg bw/ day, no mortality occurred up to day 9 (10% mortality), no other rats died at this dose level. All rats survived 500 mg/kg bw/ day.
Rats at 2000 mg/kg bw/ day had a decreased body weight at day 5 compared to day 0 (-15%). Rats exposed to 500 and 1000 mg/kg bw/ day had an increased body weight on day 5 (+46.8% and + 37.6% resp.) and day 11 (+89.4% and + 67.6% resp.) compared to their weight at day 0.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Rats and mice were orally exposed to pyridoxine hydrochloride for 10 days. Only at the lowest test doses (2000 mg/kg bw/day (mice) and 500 mg/kg bw/ day (rats)) no mortality was seen. Rats and mice dosed at the highest dose (16000 mg/ kg bw/ day) died on the first day. At 8000 mg/kg bw/ day, exposed mice and rats died after second dosing. Pyrodoxin-hydrochlorid influenced body weight gain of mice and rats in a dose-dependent way.