Registration Dossier
Registration Dossier
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EC number: 218-915-0 | CAS number: 2280-49-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide
- EC Number:
- 218-915-0
- EC Name:
- N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide
- Cas Number:
- 2280-49-1
- Molecular formula:
- C13H10Cl3NO2S2
- IUPAC Name:
- N-phenyl-N-[(trichloromethyl)sulfanyl]benzenesulfonamide
- Test material form:
- other: solid
- Details on test material:
- Purity >99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150, 500
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: the local irritation of gastric mucosa at 150 mg/kg bw leads to a NOAEL (no-observed-adverse-effect-level) of 50 mg/kg B.W.
- Dose descriptor:
- LOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: the local irritation of gastric mucosa at 150 mg/kg B.W. leads to a NOAEL (no-observed-adverse-effect-level) of 50 mg/kg B.W.
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: The NOEL for systemic effects was 500 mg/kg B.W. for both sexes
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
All animals survived until scheduled necropsy.
At 150 mg/kg B.W. necropsy and histopathology revealed minimal to moderate diffuse mucosal hyperplasia in the forestomach of 3 male and 5 females of the highest dose group of 500 mg/kg B.W. Additionally inflammation and erosion were seen in one male at 500 mg/kg B.W. These findings are evidence of local intolerance.
No systemic effects were observed at any dose.
Conclusion:
Under the conditions described above, the local irritation of gastric mucosa at 150 mg/kg B.W. leads to a NOAEL (no-observed-adverse-effect-level) of 50 mg/kg B.W. for male and female rats for N-Phenyl-N-[(trichloromethyl)thio]benzenesulphonamide after 4-week daily oral treatment by gavage. The NOEL for systemic effects was 500 mg/kg B.W. for both sexes.
Applicant's summary and conclusion
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