Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according OECD guideline, GLP, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SAT 970 419, Decansäuredimethylamid
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Lot/batch No.: Ch. 1/96
- Expiration date of the lot/batch: June 1998
- Storage condition of test material: room temperature, darkness

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, Schönwalde, Germany
- Weight at study initiation: main study mean 212g male, 168g female
- Fasting period before study: 18h prior admin
- Housing: animal room 4, filtered air, transparent polycarbonate cages (macrolonge type III), two or three rats per cage
- Diet (e.g. ad libitum): Altromin 1314 (Altromin, Lage, Germany) ad libitum
- Water (e.g. ad libitum): ad libitum (acified pH=2.5 with HCl)
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10 times/h
- Photoperiod (hrs dark / hrs light): 12h each

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE: sterile distilled water
- Concentration in vehicle: 2g/10ml
- Amount of vehicle (if gavage): ca. 8ml
- Justification for choice of vehicle: common vehicle
- Purity: 100 %

MAXIMUM DOSE VOLUME APPLIED: 10ml/kg b.wt

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Sighting study show dead in the 5000mg/kg b.wt. group whereas only signs of toxicity were observerd in the 2000 mg/kg b.wt. sighting study.
Doses:
sighting study: 5000mg/kg b.wt. (one rat), 2000mg/kg b.wt. (one rat)
main study: 2000 mg/kg b.wt.
No. of animals per sex per dose:
main study: 5 rats per sex per dose
Control animals:
no
Details on study design:
Rats were observed 1, 3 and 6 h after administration and daily for 14 days
Body weight were recorded on day 0, 7, 14
Statistics:
no statistics

Results and discussion

Preliminary study:
Preliminary study with one rat each for dosages of 5000mg/kg b.wt. and 2000 mg/kg b.wt. were performed.
Deads occured within the 5000mg dosing whereas signs of toxicity could be observed for the 2000mg dosing. Therefore it was decided to performe a limit test with 2000mg/kg b.wt.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Sighting study: 5000mg/kg b.wt. the animal died
2000mg/kg b.wt. the animal survived
Main study: 2000mg/kg b.wt. no increased mortality
Clinical signs:
Sighting study: 5000mg/kg b.wt. pinched abdomen, piloerection, ataxia, comatose
2000mg/kg b.wt. pinched abdomen, piloerection
Main study: 2000mg/kg b.wt. pinched abdomen, piloerection
Body weight:
Sighting study: surviving rat has normal body weight
Main study: rats had normal body weight gain during the study period
Gross pathology:
Main study: gross necropsy revealed a gas filled intestine (three animals), distended vessel of testes in one animal, light margin of liver in two animals
Other findings:
not stated

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS EC 1272/2008
Conclusions:
The oral LD50 of N,N-Dimethyldecan-1-amide in rats was found to be above 2000 mg/kg b.wt.
Executive summary:

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Method", July 1992 and the corresponding EEC GuidelineB.l bis "Acute Toxicity (Oral)", 29.12.1992.

The study was initiated with a sighting study, in which one female rat was given SAT 970 419 (N,N-Dimethyldecan-1 -amide) in a 2000 mg/kg b.wt. dose. Slight signs of toxicity were observed in this rat. Another female rat was given SAT 970 419 (N,N-Dimethyldecan-1-amide) in a 5000 mg/kg b.wt. dose. This animal died under severe signs of toxicity on day 2.

On the basis of the results from the sighting study it was decided to carry out the main study with one group consisting of five male and five female rats given a dose of 2000 mg/kg b.wt.

All animals in the main study survived the treatment and showed slight signs of toxicity (clinical signs: pinched abdomen, piloerection). Gross necropsy revealed a gas filled intestine for three animals, distended vessel of testes in one animal, light margin of liver in two animals.

Under the experimental conditions described in this report, the oral LD50 of SAT 970 419 (N,N-Dimethyldecan-1-amide) in rats was found to be above 2000 mg/kg b.wt.