Registration Dossier
Registration Dossier
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EC number: 256-380-5 | CAS number: 49564-57-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well perfomed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
- EC Number:
- 256-380-5
- EC Name:
- 4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
- Cas Number:
- 49564-57-0
- Molecular formula:
- C9H14N2O3S
- IUPAC Name:
- 4-amino-5-methoxy-N,2-dimethylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): Kresidinsulfmethylamid TF 9
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, breeding colony
- Age at study initiation: males: 7 weeks; females: 8 weeks
- Weight at study initiation: males: min. 176 gr max. 195 gr average 187 gr
females: min. 175 gr max 189 gr average 180 gr
- Fasting period before study: about 16 hours
- Housing: in air conditioned rooms, 5 animals in macrolone cages
- Diet : rat diet Altromin 1324 ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2% potato starch mucilage
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5, 0.63, and 0.8 %
- Amount of vehicle (if gavage): 10 ml/kg bw - Doses:
- Dose 50 mg/kg bw: Conc. 0.50 % (w/v) / Vol. 10 ml/kg bw / 5 males / - females
Dose 63 mg/kg bw: Conc. 0.63 % (w/v) / Vol. 10 ml/kg bw / 5 males / 5 females
Dose 80 mg/kg bw: Conc. 0.80 % (w/v) / Vol. 10 ml/kg bw / 5 males / - females - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily observations; weighing at day 0, 7 and 14
- Necropsy of survivors performed: yes
- Necropsy of animals found dead performed: yes - Statistics:
- Probit analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 91.5 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 63 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no lethality at 63 mg/kg bw
- Mortality:
- Dose 50 mg/kg bw: 1/5 males / -/- females
Dose 63 mg/kg bw: 2/5 males / 0/5 females
Dose 80 mg/kg bw: 2/5 males / -/- females - Clinical signs:
- other: squatting posture, flanks pinched in, spontaneous activity decreased, coat bristling, irregular respiration, stilted and uncoordinated gait, palpebral fissure narrow additionally male animals showed prone and lateral position, lid margin and snout blood-
- Gross pathology:
- animals found dead:
spleen brightened
adrenal gland darkened
thorax filled with slightly yellow viscous fluid
survivors:
no abnormal findings
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information if swallowed Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50, male rat: 91.5 mg/kg bw
Female rats did not show a higher sensitivity. - Executive summary:
When testing Kresidinsulfmethylamid TF 9 for acute oral toxicity in rats according to OECD 401 an LD50 of 91.5 mg/kg bw was calculated for males. Females did not show a higher sensitivity.
Animals showed narrowed palpebral fissures and impairment of respiration, and in the course of motion. Additionally male animals showed prone and lateral position, blood-encrusted lid margin and snout, saltatory and rolling convulsions, exophthalmos, and screaming. Males (females) were free of symptoms 4 (1) days post application.
Animals found dead revealed brightened spleen, darkened adrenal gland, and thorax filled with slightly yellow viscous fluid. Survivors were free of abnormal findings.
Body weight gain was not affected.
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