Registration Dossier
Registration Dossier
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EC number: 205-642-7 | CAS number: 144-83-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is a publication result
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
Materials and methods
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sulfapyridine
- EC Number:
- 205-642-7
- EC Name:
- Sulfapyridine
- Cas Number:
- 144-83-2
- Molecular formula:
- C11H11N3O2S
- IUPAC Name:
- 4-amino-N-pyridin-2-ylbenzenesulfonamide
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- other: mice
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- weight: 12.06-19.74 g
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 and 2 %.
Basis:
nominal in diet
- No. of animals per sex per dose:
- no data
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- The principal pathological change appears to be renal damage.
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- 1 %:
day: 0 5 10 15 20 25 28
No. of survivors: 14 14 14 14 14 14 14
Mean of total dose eaten by survivors: 0.814 g
2 %:
day: 0 5 10 15 20 25 28
No. of survivors: 28 28 28 28 27 27 27
Mean of total dose eaten by survivors: 1.477 g
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 1 %:
day: 0 5 10 15 20 25 28
No. of survivors: 14 14 14 14 14 14 14
Mean of total dose eaten by survivors: 0.814 g
2 %:
day: 0 5 10 15 20 25 28
No. of survivors: 28 28 28 28 27 27 27
Mean of total dose eaten by survivors: 1.477 g - Executive summary:
Mice were fed the Sherman No. 1 diet containing the drugs in concentrations of 1 and 2 %. The result was as follows:
1 %:
day: 0 5 10 15 20 25 28
No. of survivors: 14 14 14 14 14 14 14
Mean of total dose eaten by survivors: 0.814 g
2 %:
day: 0 5 10 15 20 25 28
No. of survivors: 28 28 28 28 27 27 27
Mean of total dose eaten by survivors: 1.477 g
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