(Z)-N-octadecyldocos-13-enamide

Acute Toxicity: oral

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:

guideline study

Remarks:

GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-octadecylstearamide

EC Number:

236-276-6

EC Name:

N-octadecylstearamide

Cas Number:

13276-08-9

Molecular formula:

C36H73NO

IUPAC Name:

N-octadecyloctadecanamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Credo, Brussels, Belgium
- Age at study initiation: 9-10 weeks
- Weight at study initiation: males 311-340 g, females 212-229 g
- Fasting period before study: yes, feed was withheld twice; once overnight before the first dosing until approximately 3.5-4 hours after administration of the test substance and a second time for 12-12.5 hours overnight before the second dosing until approximately 3.5-4 hours after administration. Between the two fasting periods there was a 4.75-hour feeding period.
- Housing: Individually in polycarbonate cages with purified sawdust (Woody Clean, The Broekman Institute, Someren, The Netherlands) as bedding material.
- Diet: Standard laboratory animal diet RMH-B, pellet diameter 10 mm (Hope Farms, Woerden, The Netherlands), ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 50-95
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 160 mg/mL; adequate dose was determined by a dose range finding investigation.
- Amount of vehicle (if gavage): 7.5 mL/kg bw
- Justification for choice of vehicle: limited solubility of test substance water; common vehicle for oral administration

MAXIMUM DOSE VOLUME APPLIED: always 7.5 mL/kg bw, twice within 24 hours

DOSAGE PREPARATION (if unusual):
The test substance was warmed to its melting point (approximately 80 °C) and was suspended in corn oil (maydis oleum, ACF, Maarssen, The Netherlands). Prior to dosing the suspension was heated to approximately 85 °C and was transferred to a glass syringe; subsequently the suspension was cooled by either waiting for a while or by holding the syringe under running cold tap water. The suspension was then administered using a stainless steel stomach cannula. The suspensions were prepared daily.

Doses:

2400 mg/kg bw (2 x 1200 mg/kg bw within 24 hours)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage-side observations were performed on the day of dosing (approx. once every 2 hours) and daily thereafter. With exception of weekends and holidays a mortality check was performed at the end of the day. Individual body weights (with group means and standard deviation) were measured weekly.
- Necropsy of survivors performed: yes, animals sacrificed on day 14 by CO2-asphyxiation and subjected to autopsy
- Other examinations performed: clinical signs, body weight, gross abnormalities

Statistics:

Group means of body weight and standard deviations.

Results and discussion

Preliminary study:

In order to establish an appropriate dose range six groups of Wistar rats, each comprising 1 male and 1 female, were dosed with an oral dose of the test substance at 2400, 1800, 1000, 560, 320 and 180 mg/kg bw, respectively. No mortalities occurred and no signs of systemic toxicity were observed during the 7-day observation period. Based on the absence of toxicity one group of animals (5 males and 5 females) was dosed with a total oral dose of 2400 mg/kg bw (twice 1200 mg/kg bw). This was the maximum dose that could be prepared for feasible oral dosing in this species.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 400 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred.

Clinical signs:

other: No signs of systemic toxicity were observed during the 14-day observation period.

Gross pathology:

No test substance-related gross abnormalitites were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008