N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

Endpoint summary

Description of key information

The NOEL for systemic effects was 500 mg/kg B.W., the highest dose tested, for both sexes. Local irritation of gastric mucosa was observed in the sub-acute toxicity study at 150 mg/kg B.W. leading to a local 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.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

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

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)

Species:

rat

Strain:

Wistar

Sex:

male/female

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

Remarks:

Doses / Concentrations:
0, 50, 150, 500
Basis:
actual ingested

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

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

Critical effects observed:

not specified

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

500 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

guideline study according to GLP; local effects are observed at lower doses (NOAEL local effects: 50 mg/kg/day)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Local irritation of gastric mucosa was observed in the sub-acute toxicity study at 150 mg/kg B.W. leading to a local 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., the highest dose tested, for both sexes.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Guideline study according to GLP

Justification for classification or non-classification

Local irritation of gastric mucosa was observed in the sub-acute toxicity study at 150 mg/kg B.W. leading to a local 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., the highest dose tested, for both sexes.