Registration Dossier
Registration Dossier
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EC number: 201-182-6 | CAS number: 79-16-3
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:
- guideline study with acceptable restrictions
- Remarks:
- partly limited documentation, e.g. no details about test substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
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-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 99.9%
no further details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Initial body weight: 142-165 g in males and 132-167 g in females
No further details.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- concentration in test solution 20% at a dose level of 1600 µl/kg bw, 30% at all other dose levels
no data about fasting prior to application - Doses:
- 1600, 3200, 4000, 5000, and 6400 µl/kg bw
with a density of 0.975 @25°C: 1560, 3120, 3900, 4875, 6240 mg/kg - No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: (presumably) daily
- weighing: no data
- Necropsy of survivors and rats found dead - Statistics:
- LD50 estimated; no data about confidence limits
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 200 other: µl/kg bw
- Remarks on result:
- other: corresponding to 4095 mg/kg bw
- Mortality:
- Data on mortality are presented in the Table below. At the high dose level rats died within 2 days (at other dose levels within 7 days).
- Clinical signs:
- other: at 1600 µl/kg bw: no effects 3200 µl/kg bw: 1/10 rats with alopecia (head) 4000 µl/kg bw: no symptoms (but mortality) 5000 µl/kg bw: ruffled coat, apathy, side position 6400 µl/kg bw: bloody muzzle (day 2), adhered eyes, tremor, apathy
- Gross pathology:
- Surviving rats: no treatment related effects.
Rats found dead: congestion of liver and lung, degeneration of the heart, liver coloured (dark yellow); loss of weight - Other findings:
- no data
Any other information on results incl. tables
Acute toxicity in male (m) and female (f) rats after oral application of monomethylacetamide
Dose in µl/kg bw |
Number of rats which died within |
||||
1 hour |
24 hours |
48 hours |
7 days |
14 days |
|
6400 |
0/5m |
0/5m |
4/5m |
5/5m |
5/5m |
5000 |
0/5m |
0/5m |
0/5m |
5/5m |
5/5m |
4000 |
0/5m |
0/5m |
0/5m |
1/5m |
1/5m |
3200 |
0/5m |
0/5m |
0/5m |
0/5m |
0/5m |
1600 |
0/5m |
0/5m |
0/5m |
0/5m |
0/5m |
Applicant's summary and conclusion
- Conclusions:
- The oral LD50 is 4200 µl/kg bw in male and female rats combined; corresponding to 4095 mg/kg bw with a density of 0,975 g/cm3.
- Executive summary:
The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about test animals).
Groups of 5 male and 5 female rats were gavaged with 20 or 30% aqueous solutions at dose levels of 1600, 3200, 4000, 5000, and 6400 µl/kg bw. The post exposure observation period was 14 days. At the high dose levels rats died within 2 days.Clinical signs like ruffled coat, apathy, side position occurred and in the high dose group also bloody muzzle (day 2), adhered eyes, and tremor; no treatment related effects were seen in survivors. Necropsy revealed also no treatment related effects in survivors; rats found dead showed congestion of liver and lung, degeneration of the heart, coloured liver coloured (dark yellow), and loss of weight.
Conclusion: The oral LD50 is 4200 µl/kg bw corresponding to 4095 mg/kg bw in male and female rats combined.
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