Registration Dossier
Registration Dossier
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EC number: 219-983-4 | CAS number: 2591-76-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-05-10 to 1988-05-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented, scientifically acceptable study report.
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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,7950 Biberach, Germany
- Weight at study initiation (mean): males: 261 g, females: 222 g
- Housing: Single housing in stainless steel wire mesh cages, Typ DK-III (Becker & Co., Castrop-Rauxel)
- Diet: Standardized animal laboratory diet, ad libitum (Kliba-Labordiaet 343, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland)
- Water: Tap water ad libitum
- Acclimation period: For at least one week
- Animal identification: Identification of groups using cage cards
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours dark/ 12 hours light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk (about 50 cm²)
- Type of wrap if used: Covered with a porous dressing (four layers absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application side with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2.29 mL/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- 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 application, at least once each workday. Check for moribund and dead animals twice each workday and once on 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:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Symptoms and local findings: no abnormalities
- Gross pathology:
- no pathologic findings noted
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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