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EC number: 240-367-6 | CAS number: 16260-09-6
Toxicological information
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:
- 1 986
- 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
- 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
- Reference substance name:
- (Z)-N-octadec-9-en-1-ylhexadecanamide
- Molecular formula:
- C34H67NO
- IUPAC Name:
- (Z)-N-octadec-9-en-1-ylhexadecanamide
- Reference substance name:
- oleyl palmitamide
- IUPAC Name:
- oleyl palmitamide
- Test material form:
- other: solid, not further specified
1
Constituent 1
Constituent 2
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 levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 400 mg/kg bw
- Based on:
- test mat.
- 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
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