(Z)-N-octadec-9-enylhexadecan-1-amide

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

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

1

Reference substance name:

(Z)-N-octadec-9-enylhexadecan-1-amide

EC Number:

240-367-6

EC Name:

(Z)-N-octadec-9-enylhexadecan-1-amide

Cas Number:

16260-09-6

Molecular formula:

C34H67NO

IUPAC Name:

N-octadec-9-en-1-ylhexadecanamide

Constituent 1

Reference substance name:

(Z)-N-octadec-9-en-1-ylhexadecanamide

Molecular formula:

C34H67NO

IUPAC Name:

(Z)-N-octadec-9-en-1-ylhexadecanamide

Constituent 2

Reference substance name:

oleyl palmitamide

IUPAC Name:

oleyl palmitamide

Test material form:

other: solid, not further specified

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 326-352 g, females 206-238 g
- Fasting period before study: yes, feed was withheld twice; once overnight before first dosing until approximately 3-3.5 hours after administration and a second time 10-11 hours overnight before the second dosing until approximately 4 hours after administration of the test substance. Between the two fasting periods there was a 3-hour feeding period.
- Housing: Individually in polycarbonate cages; Bedding material (purified sawdust, Woody Clean, was recceived from the Broekman Institute, Someren, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory animal diet (RMH-B, pellet diameter 10 mm), which was obtained from Hope Farms, Woerden, The Netherlands, ad libitum.
- Water (e.g. ad libitum): 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
- Amount of vehicle (if gavage): 7.5 mL
- Justification for choice of vehicle: very low water solubility of test substance

MAXIMUM DOSE VOLUME APPLIED: 2 times 7.5 mL/kg within 24 hours

DOSAGE PREPARATION (if unusual):
The test substance was heated to melting point (approximately 60 °C) and suspended in corn oil (maydis oleum, ACF, Maarssen, The Netherlands). Prior to dosing the suspension was heated to approximately 65 °C and was transferred to a glass syringe; subsequently the syringe was cooled under running cold tap-water and the suspension was administered using a stainless steel cannula.

Doses:

2400 mg/kg bw (twice 1200 mg/kg bw : maximum dose feasible for oral administraion)

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 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, at the end of the study (Day 14) all surviving animals were sacrificed by CO2-asphyxiation and subjected to autopsy.
- Other examinations performed: clinical signs, body weight

Statistics:

Body weight group means with 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.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 400 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 400 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of systemic toxicity were observed during the 14-day observation period with exception of Day 1 when lethargy was frequently observed. There was no evident sex-related effect.

Gross pathology:

There were no test substance-related gross abnormalitites.

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