Registration Dossier
Registration Dossier
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EC number: 233-593-1 | CAS number: 10254-57-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 18 June to 03 July 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-methylene bis(dibutyldithiocarbamate)
- EC Number:
- 233-593-1
- EC Name:
- 4,4'-methylene bis(dibutyldithiocarbamate)
- Cas Number:
- 10254-57-6
- Molecular formula:
- C19H38N2S4
- IUPAC Name:
- N,N-dibutyl({[(dibutylcarbamothioyl)sulfanyl]methyl}sulfanyl)carbothioamide
- Reference substance name:
- 4,4'-Methylene(dibutyldithiocarbamate)
- IUPAC Name:
- 4,4'-Methylene(dibutyldithiocarbamate)
- Details on test material:
- Batch No.: not specified
Purity: not specified
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: The rats were deprived of food but not water overnight prior to dosing.
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.
IN-LIFE DATES: From: 18 June 1980 To: 03 July 1980
No additional data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Each animals was dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. Deviations are considered not to effect the validity of the study result.
- Doses:
- 1.0, 2.0, 4.0, 8.0 and 16.0 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed once daily, weighed on initial day and final day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology. - Statistics:
- None stated
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed.
- Clinical signs:
- other: No untoward symptoms were observed at the dosage levels of 1.0-8.0 g/kg. At 16.0 g/kg the animals were slightly dirty and ruffled after 18-24 hours. They appeared normal and clean after 48 hours.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of Methylenebis (dibutyldithiocarbamate) to rats is greater than 16.0 g/kg.
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