Registration Dossier
Registration Dossier
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EC number: 256-435-3 | CAS number: 49701-24-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-amino-2,5-dimethoxy-N-methylbenzenesulphonamide
- EC Number:
- 256-435-3
- EC Name:
- 4-amino-2,5-dimethoxy-N-methylbenzenesulphonamide
- Cas Number:
- 49701-24-8
- Molecular formula:
- C9H14N2O4S
- IUPAC Name:
- 4-amino-2,5-dimethoxy-N-methylbenzene-1-sulfonamide
- Details on test material:
- purity: 97.8 - 98.0 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hoe: WISKf(SPF71)
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: males about 7 weeks; females about 8 weeks
- Weight at study initiation: males 188-206 g; females:183 - 189 g
- Fasting period before study: 16 hours
- Housing:in macrolon cages with granulated soft wood in groups with 5 animals; fully airconditioned rooms
- Diet: rat diet Altromin 1324 ad libitum
- Water: tap water from plastic dispensers ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod:12 hrs light daily
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2% starch
- Doses:
- Dose Concentration Applicationvolume Number of animals
mg/kg bw % (w/v) ml/kg bw males females
630 6.6 10 5 -
1000 10.0 10 5 -
1600 16.0 10 5 5
2000 20.0 10 5 -
3150 31.5 10 5 - - No. of animals per sex per dose:
- see above
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 rsp. 21 days
- Frequency of observations: daily and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopic observation - Statistics:
- LD50 , 95% confidence interval and the euation of the Porbit curve were calculated from the letality of the males by Probit Analysis
Results and discussion
- Preliminary study:
- Pre Test
670 mg/kg bw 1 male + 1 female Day 10 female dead
1000 mg/kg bw 1 male + 1 female Day 3 male dead
2000 mg / kg bw no animal died
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 630 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- other: LD40
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- other: LD40
- Effect level:
- 1 600 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- other: LD20
- Effect level:
- 1 600 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- other: LD40
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- other: LD60
- Effect level:
- 3 150 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 230 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: calculated
- Mortality:
- Dose Letality
mg/kg bw males females
630 0/5 --
1000 2/5 --
1600 2/5 1/5
2000 2/5
3150 3/5 - Clinical signs:
- other: decreased spontaneous activity, coat bristling, squatting posture, flanks pinched in, gait: stilted, uncoordinated, ataxic, irregular and panting respirate, decreased respiration rate, stupot
- Gross pathology:
- liver, lung, kidneys
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- based on the results the substance has not to be classified for acute oral toxicity
- Executive summary:
Testing for acute oral toxicity was performed according to OECD guideline 401. Following concentrations were used for male rats:
630, 1000, 1600, 2000, 3150 mg / kg bw; for females only 1600 mg/kg bw. Mortality occurred in all concentrations except for the lowest one. Out of the results a LD50 of 2230 mg/ kg bw can be calculated
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