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Toxicological information

Acute Toxicity: oral

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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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Dodecane-12-lactam of Hüls AG, purity > 99.9 %; main impurity cyclododecanone approx. 100 ppm

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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 continued to show convulsive twitches and impairment of breathing. Later on, moderate to severe sedation and ataxia, salivation, hypothermia, staggering, crouched posture, closed or small dark eyes and, in some animals, diarrhea were observed. After 2-3 days, the animals showed a ruffled fur, increase in motility and, in part, vocalisation when being touched. Signs of toxicity had disappeared after 11 days in the animals of the three lower dose groups, while the animals of the highest dose group (3160 mg/kg) showed signs of toxicity during the 14-day observation period.
Body weight:
Increase of body weight was practically unaffected by the treatment.
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

no further remarks

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.