Registration Dossier
Registration Dossier
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EC number: 219-983-4 | CAS number: 2591-76-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-04-13 to 1988-04-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented, scientifically acceptable study report; no GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N-bis(2-methylpropyl)formamide
- EC Number:
- 219-983-4
- EC Name:
- N,N-bis(2-methylpropyl)formamide
- Cas Number:
- 2591-76-6
- Molecular formula:
- C9H19NO
- IUPAC Name:
- N,N-bis(2-methylpropyl)formamide
- Details on test material:
- - Name of the test substance used in the study report: Diisobutylformamid
- Purity: Please refer to section 1.2 for purity information.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Weight at study initiation: males: 193 g; females: 179 g
- Fasting period before study: Yes, 16 hours before administration.
- Housing: groupwise (5 animals per cage)
- Diet: ad libitum (Kliba Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum (tap water)
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.64, 10.0, 21.5 g/100 mL (w/v)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 464, 1000 and 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
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration (at least once each working day). A check of moribund or dead animals was made twice each working day and once on public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 464 - < 1 000 mg/kg bw
- Mortality:
- No mortality was observed in the lowest dosing group. 4 males and all females died at 1000 mg/kg bw. All animals died in the highest dosing group.
- Clinical signs:
- other: dyspnea, apathy, abnormal position, staggering, twitching, extention, saltatory and flexion spasms, rolling convulsions, piloerection, exophthalamus (females only), salivation, poor general state
- Gross pathology:
- Animals that died: general congestion
Sacrificed animals: no pathologic findings noted
Applicant's summary and conclusion
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