Registration Dossier
Registration Dossier
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EC number: 213-424-8 | CAS number: 947-04-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-01-09 - 1985-01-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dodecane-12-lactam
- EC Number:
- 213-424-8
- EC Name:
- Dodecane-12-lactam
- Cas Number:
- 947-04-6
- Molecular formula:
- C12H23NO
- IUPAC Name:
- 1-azacyclotridecan-2-one
- Test material form:
- solid
- Details on test material:
- Dodecane-12-lactam of Hüls AG, purity > 99.9 %; main impurity cyclododecanone approx. 100 ppm
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Wistar (Bor: WISW (SPF TNO))
- Source: Winkelmann, Borchen (Germany)
- Weight at study initiation:
females 117 g, males 126 g (mean) environmental conditions: Feed: R 10 complete feed for rats (Ssniff, Soest; Germany); Water: tap water ad libitum; Room temperature: 20°C (+/- 1°C); Humidity: 60% (+/- 5%), Air change: 15 times per hour; illumination: 12 hour light/dark rhythm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: fatty alcohol ethoxylate (Cremophor EL)
- Details on oral exposure:
- - Test substance preparation: the test substance was finely ground in a mortar, mixed with cremophor EL, stirred in an Ultra-Turrax and then heated to 40 °C.
- Single dose after 16 h of fasting
- Volume administered or concentration: 20 ml/kg - Doses:
- - Doses: 1580 / 1990 / 2510 / 3160 mg/kg bw (gavage),
selected after screening test with small number of animals - No. of animals per sex per dose:
- 5; highest dose: 10
- Control animals:
- no
- Details on study design:
- - Post dose observation period: 14 days
EXAMINATIONS:
- body weight: before and on days 1, 7, 14 after treatment
- clinical signs: up to 6 hours after treatment, then daily
- gross pathology at the end of investigation - Statistics:
- Litchfield and Wilcoxon (1949), J. Pharmacol. Exp. Ther. 96, 99
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 330 mg/kg bw
- 95% CL:
- 2 044 - 2 656
- Mortality:
- 1580 mg/kg: none
1990 mg/kg: 3 males, 1 female, within 24 hours
2510 mg/kg: 1 male, 5 females, within 24 hours
3160 mg/kg: 8 males, 7 females, within 72 hours - Clinical signs:
- other: Observed in all dosed animals: About 10 to 15 minutes after adminstration, the animals took a prone position and showed convulsive twitches, tremor and Straub's phenomenon. After half an hour, the animals took a lateral position, had a ruffled fur and con
- Gross pathology:
- Post-mortem dissection revealed hyperaemia of the gastric and intestinal mucosae, hyperaemia of the lungs, light-coloured spots on the liver and liver congestion. Dissection at the end of the experiment also revealed hyperaemia of the gastric and intestinal mucosae in some animals.
- Other findings:
- no further information
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item Dodecane-12-lactam (lauryl lactame) is 2330 mg/kg of body weight. Under the conditions of this study the acute toxicity of Dodecane-12-lactam (lauryl lactame) afer oral application in rats is very low.
- Executive summary:
In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item Dodecane-12-lactam (lauryl lactame) is 2330 mg/kg of body weight. In few cases, the treated animals showed signs of toxicity during the 14 day observation period. There was no influence on the increase in body weight. Dissection at the end of the experiment revealed hyperaemia of the gastric and intestinal mucosae in some animals.
Under the conditions of this study the acute toxicity of Dodecane-12-lactam (lauryl lactame) after oral application in rats is very low.
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