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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
not specified
Remarks:
migrated information
Adequacy of study:
weight of evidence
Study period:
1964
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Basic details provided, Single dose study involving male animals only. Limited parameters were evaluated
Justification for type of information:
Basic details provided, Single dose study involving male animals only. Limited parameters were evaluated
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Influence of Nicotinic, Picolinic and Pyridine-3-sulfonic Acids on Cholesterol Metabolism in the Rat
Author:
Kritchevsky D and Tepper SA
Year:
1964
Bibliographic source:
J. Nutr. January 1, 1964 vol. 82 no. 1 157-161

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Animals were treated with test substance through dietary administration for three weeks and observed for limited parameters including mortality, body weight, food consumption and liver weight.
GLP compliance:
no
Remarks:
pre-GLP
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-3-sulphonic acid
EC Number:
211-265-9
EC Name:
Pyridine-3-sulphonic acid
Cas Number:
636-73-7
Molecular formula:
C5H5NO3S
IUPAC Name:
pyridine-3-sulfonic acid
Test material form:
not specified
Specific details on test material used for the study:
- Name of test material: Pyridine-3-sulfonic acid
- Molecular formula: C5-H5-N-O3-S
- Molecular weight: 159.165
- Smiles notation: S(c1cnccc1)(=O)(=O)O
- Substance type: Pure active substance

No further details were provided in the publication

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150-160g
- Diet: Rats were fed on the basal test diet or control diet (ad libitum), as described under 'Details on oral exposure'.

No further details on test animal were provided

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: diet admixed
Details on oral exposure:
DIET PREPARATION:

Test diet: The basal test diet contained, per 100g: cereal mixture 70g; wheat germ 6.25g; skim milk powder 20g; vitamin mixture 2.75g; and test compound 1.0g. Sufficient water was added to make a thick dough.

Control diet: The control diet contained 70g of cereal mixture.

- No further details were provided in the publication
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
3 weeks
Frequency of treatment:
Continuously in diet (ad libitum)
Doses / concentrations
Remarks:
Doses / Concentrations:
0 and 1%
Basis:
nominal in diet
No. of animals per sex per dose:
5 males/dose group
Control animals:
other: control diet (refer to details on oral exposure)
Details on study design:
No details were provided in the publication
Positive control:
no

Examinations

Observations and examinations performed and frequency:
- Animals were observed for Mortality, Body weight gain and Food consumption
Sacrifice and pathology:
- All surviving animals were sacrificed on completion of the 3 week treatment period. No relevant pathological examination were performed
Other examinations:
- Organ weight: Liver weight was examined for all experimental animals
Statistics:
Findings were presented as group mean value with standard deviations

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No mortality was noted
Mortality:
no mortality observed
Description (incidence):
No mortality was noted
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
not examined
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
MORTALITY
- All experimental animals survived to the scheduled sacrifice

BODY WEIGHT AND WEIGHT GAIN
- The control group exhibited a greater body weight gain than did the test group. However, this difference was not statistically significant.

FOOD CONSUMPTION AND COMPOUND INTAKE
- No anorexia (as evidenced by reduced weight gain) was observed in any group

ORGAN WEIGHTS
- Group mean Liver weight of test group was low when compared to the control group. However, this difference was not statistically significant.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
>= 900 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No significant differences observed in mortality; body weight; food consumption; and organ weights (liver) of test animals

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Administration of test substance to male wistar rats at dose level of 1% in diet (equivalent to 900 mg/kg bw/day) for 3 weeks, did not produce any adverse effects attributable to treatment with test substance. Under the conditions of this study, NOAEL was determined to be 900 mg/kg bw/day.
Executive summary:

Male wistar rats were treated with test substance at dose level of 1% in diet (equivalent to 900 mg/kg bw/day) for 3 weeks and observed for limited parameters including mortality, body weight, food consumption and liver weight. Group of animals that received basal untreated diet, served as control.No treatment related adverse effects were observed. Under conditions of this study, NOAEL was determined to be 900 mg/kg bw/day.