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EC number: 205-642-7 | CAS number: 144-83-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientific research with rational method
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sulfasalazine (SASP)
- IUPAC Name:
- Sulfasalazine (SASP)
- 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
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Porton strain
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Central Animal House, Panjab University, Chandigarh
- Weight at study initiation: Sexually mature Males: 150-200 g
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet: pelleted standard laboratory feed ad libitum
- Water: water ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 40 ± 5%
- Photoperiod: 12 h light, 12 h darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Sulfasalazine at doses of 125, 250, 500 mg/ kg body weight and sulfapyridine at doses of 60, 120 and 250 mg kg/ body weight suspended in 0.5 mL of corn oil was administered to male rats (six animals in each group) by oral intubation daily for 60 days.
- Analytical verification of doses or concentrations:
- no
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
125, 250, 500 mg/kg body weight
Basis:
nominal conc.
Sulfasalazine
- Remarks:
- Doses / Concentrations:
60, 120 and 250 mg/kg body weight
Basis:
nominal conc.
sulfapyridine
- No. of animals per sex per dose:
- 6 males per group
- Control animals:
- yes, concurrent vehicle
- Positive control:
- No
Examinations
- Statistics:
- Student’s Mest.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- sperm motility was reduced significantly at the higher dose levels
- Reproductive performance:
- not specified
Details on results (P0)
No morphological changes in the histoarchitecture of the testis were discernible and all germinal elements were intact. There was a marginal decrease in the step 19 spermatid: step 7 spermatid ratio in the animals receiving 500 mg of sulfasalazine. No significant changes in tubular diameter or germinal height were observed in sulfasalazine treated animals.
A marginal (3.88%) decrease was seen in germinal height and tubular diameter of the sulfapyridine treated group.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The study precludes the testis as a site of action of sulfasalazine and sulfapyridine and confirms earlier observations that the effect of these two test substances is post- testicular at the level of the epididymis.
- Executive summary:
Sulfasalazine at doses of 125, 250, 500 mg/ kg body weight and sulfapyridine at doses of 60, 120 and 250 mg kg/ body weight suspended in 0.5 mL of corn oil was administered to male rats (six animals in each group) by oral intubation daily for 60 days.
Sperm motility was reduced significantly at the higher dose levels of sulfasalazine and sulfapyridine. An increased frequency of abnormal spermatozoa was seen. Significant reductions in sperm reserves were encountered, 46% and 29% in the caput and cauda sperm reserves at 500 mg dose of sulfasalazine. A significant fall (56%) occurred in the cauda of animals given sulfapyridine (250 mg). Total sperm reserves also decreased (28.91% and 34.93%) at the highest dose levels of sulfasalazine and sulfapyridine. No morphological changes in the histoarchitecture of the testis were discernible and all germinal elements were intact. There was a marginal decrease in the step 19 spermatid: step 7 spermatid ratio in the animals receiving 500 mg of sulfasalazine. No significant changes in tubular diameter or germinal height were observed in sulfasalazine treated animals. A marginal (3.88%) decrease was seen in germinal height and tubular diameter of the sulfapyridine treated group.
Neither of the two test substances, at the dose levels employed, caused major disturbances in the histomorphological profile of the testis as far as the different stages of spermatogenesis are concerned. Histoarchitecture was also retained and comparable with that of the controls.
The two test substances did not affect the earlier stages of spermatogenesis that proceed to form step 19 spermatids.
Thus, this study precluded the testis as a site of action of sulfasalazine and sulfapyridine and confirms earlier observations that the effect of these two test substances was post- testicular at the level of the epididymis.
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