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EC number: 204-826-4 | CAS number: 127-19-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study with acceptable restrictions (no details about the test substance or decrease in body weight; no non-lethal dose in females; no necropsy at termination).
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute and subchronic toxicity of dimethylformamide and dimethylacetamide following various routes of administration
- Author:
- Kennedy GL & Sherman H
- Year:
- 1 986
- Bibliographic source:
- Drug Chem Toxicol 9: 147-170
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-dimethylacetamide
- EC Number:
- 204-826-4
- EC Name:
- N,N-dimethylacetamide
- Cas Number:
- 127-19-5
- Molecular formula:
- C4H9NO
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: dimethylacetamide (DMAC) No details available.
Test animals
- Species:
- rat
- Strain:
- other: ChR-CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult rats
- Weight at study initiation: males 198-224 g, females 166-183 g
No further details available.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- 50 % solution in water; average of 2.17-2.84 mL per male rat or 1.58-2.05 mL per female rat
- Doses:
- 5000, 5500, 6000, 6500 mg/kg bw in males
4500, 5000, 5500, 6000 mg/kg bw in females - No. of animals per sex per dose:
- 10 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14-15 days
- Observations (frequency): yes (presumably daily)
- Weighing: yes, but no details
- Necropsy of survivors performed: no
- Sacrifice: 14-15 days after application - Statistics:
- Probit analysis (Finney)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 810 mg/kg bw
- Remarks on result:
- other: 95% CL not defined
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 930 mg/kg bw
- Remarks on result:
- other: 95% CL not defined
- Mortality:
- Details are presented in Table 1.
In males 3/10 animals died at 5500 mg/kg bw, 9/10 at 6000 mg/kg bw and 7/10 at 6500 mg/kg bw. No males died at 5000 mg/kg bw.
In females 4/10 animals died at 4500 mg/kg bw, 2/10 at 5000 mg/kg bw, 9/10 at 5500 mg/kg bw and 10/10 at 6000 mg/kg bw. - Clinical signs:
- other: Belly-to-cage posture; wet and/or stained mouth, nose and perineal area; eyes half closed; diarrhea, tremors, piloerection, pallor, prostration, lethargy, chromodacryorrhea and cyanosis were noted.
- Gross pathology:
- No data
Any other information on results incl. tables
Table 1: Mortality in male and female ChR-CD rats after gavage within the post exposure observation period of 14 days
| Dose (mg/kg bw) | Mortality in males | Mortality in females |
| 6500 | 7/10 | not tested |
| 6000 | 9/10 | 10/10 |
| 5500 | 3/10 | 9/10 |
| 5000 | 0/10 | 2/10 |
| 4500 | not tested | 4/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 = 5810 mg/kg bw (males); LD50 =and 4930 mg/kg bw (females).
- Executive summary:
Groups of 10 ChR-CD rats per sex per dose were gavaged with 4500 - 6500 mg/kg bw (4 dose levels per sex). The post exposure observation period was 2 weeks.
Male rats died at a dose level >=5500 mg/kg bw and no mortality was found at 5000 mg/kg bw. In females even at the low dose level lethal effects were seen.
Clinical signs like belly-to-cage posture, wet and/or stained mouth, nose and perineal area, half closed eyes, diarrhea, tremors, piloerection, pallor, prostration, lethargy, chromodacryorrhea, and cyanosis were recorded.
Conclusion: In male ChR-CD rats the oral LD50 was 5810 mg/kg bw and in females 4930 mg/kg bw.
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