Registration Dossier
Registration Dossier
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EC number: 201-182-6 | CAS number: 79-16-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study with acceptable restrictions (pregnant rats used; partly limited documentation, e.g. no details about doses).
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryotoxicity in rats and rabbits from cutaneous application of amide-type solvents and substituted ureas
- Author:
- Stula EF, Krauss WC
- Year:
- 1 977
- Bibliographic source:
- Toxicol Appl Pharmacol 41: 35-55
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Approximate lethal dose procedures
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- other: Approximate lethal dose procedures
- Limit test:
- no
Test material
- Reference substance name:
- N-methylacetamide
- EC Number:
- 201-182-6
- EC Name:
- N-methylacetamide
- Cas Number:
- 79-16-3
- Molecular formula:
- C3H7NO
- IUPAC Name:
- N-methylacetamide
- Details on test material:
- Purity >=98%
no further details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- primigravida rats, 220-250 g bw
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- One animal used per dose level; rats were treated on gestation day 11
- Duration of exposure:
- unwashed
- Doses:
- dose level with a factor of 1.5 between dose levels
no further details - No. of animals per sex per dose:
- 1 female
- Control animals:
- not required
- Details on study design:
- animals sacrificed gestation day 20.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- other: approximate lethal dose
- Effect level:
- 11 000 mg/kg bw
- Remarks on result:
- other: pregnant rats
Any other information on results incl. tables
No further details were presented.
Applicant's summary and conclusion
- Conclusions:
- In pregnant Sprague-Dawley rats the approximate lethal dose was 11000 mg/kg bw after dermal exposure.
- Executive summary:
Comparable to Guideline study with acceptable restrictions (pregnant rats used; partly limited documentation, e.g. no details about doses).
The approximate lethal dose in pregnant Sprague-Dawley rat was determined. One rat per dose level received dermal application (coverage: open) at gestation day 11. The post exposure period was 9 days.
Conclusion: In pregnant Sprague-Dawley rats the approximate letal dose was 11000 mg/kg bw after dermal exposure.
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