Registration Dossier
Registration Dossier
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EC number: 212-090-0 | CAS number: 761-65-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N-dibutylformamide
- EC Number:
- 212-090-0
- EC Name:
- N,N-dibutylformamide
- Cas Number:
- 761-65-9
- Molecular formula:
- C9H19NO
- IUPAC Name:
- N,N-dibutylformamide
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight: males 205 g, females 163 g
The animals were offered a standardized animal laboratory diet.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- 0.5% aqueous CMC preparation
Test concentrations used were 2.15, 3.16, 4.64, 6.81, 10, 12.1, 14.7, 21.5% (G/V). - Doses:
- 215, 316, 464, 681, 1000, 1210, 1470, 2150 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- Application volume: 10 mL/kg
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 050 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 215, 316 and 464 mg/kg bw: no deaths after 14 days
681 mg/kg bw: 1/10 after 14 days
1000 mg/kg bw: 2/10 after 14 days
1210 mg/kg bw: 9/10 after 14 days
1470 and 2150 mg/kg bw: 10/10 after 14 days - Clinical signs:
- other: Time of deaths on the first study day. Staggering, atony, narcotic-like state with missing pain and corena reflex, spastic gait, partly salivation and lachrymation.
- Gross pathology:
- Animals that died:
- heart: acute congestion, acute congestive hyperemia
- lung: manifold slight edematized
- liver: manifold disseminated lobule periphery;
- stomach: partly substance-induced mucosa malacia
- intestine: partly atonic, diarrheic content.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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