Registration Dossier
Registration Dossier
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EC number: 251-607-4 | CAS number: 33629-47-9
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:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- EC Number:
- 251-607-4
- EC Name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- Cas Number:
- 33629-47-9
- Molecular formula:
- C14H21N3O4
- IUPAC Name:
- N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley (SD) rats, five weeks of age.
The animals were quarantiner for 7 days prioir to test article administration.
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 700 mg/kg
1000 mg/mkg
1200 mg/kg
1600 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 5
- Control animals:
- yes
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 169.5 mg/kg bw
- 95% CL:
- >= 914.4 - <= 1 495.9
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 1 049 mg/kg bw
- 95% CL:
- >= 818.1 - <= 1 345.1
Applicant's summary and conclusion
- Conclusions:
- The LD50 was calculated to be 1169.5 mg/kg with a 95% confidence level of 914.4 to 1495.9 for the male rats and 1049.0 mg/kg with 95% confidence level of 818.1 to 1345.1 for the females.
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