Octadecanoic acid, C16-18-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Sep - 08 Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted Dec 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Docosyl stearate

EC Number:

244-971-0

EC Name:

Docosyl stearate

Cas Number:

22413-03-2

Molecular formula:

C40H80O2

IUPAC Name:

docosyl octadecanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

SPF [Crl:CD(SD)]

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Laboratories Japan Inc, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 197 - 203 g (range)
- Fasting period before study: Yes, approximately 18 h overnight
- Housing: 2 or 3 animals per cage were housed in plastic solid-floored cages (W 440 x D 275 x H 180 mm; by Hanyu Seimitsu Inc.) with bedding (ALPHA-dri, Shepherd Specialty Papers, Inc., Lot Nos: 04116 and 05116).
- Diet: CR -LPF pelleted diet (irradiation-sterilized, Oriental Yeast Co., Ltd., Lot No.: 160621), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Animals were quarantined/acclimated to the test environment for over a week at the testing facility.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24
- Humidity (%): 39 - 48
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Sep 2016 To: 08 Dec 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since the acute oral toxicity of the test substance was expected to be low, the starting dose level was set at 2000 mg/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (first and second step, respectively)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently for the first 6 hours after administration (from immediately after administration to 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after administration), and once daily thereafter for 14 days, for clinical signs such as abnormalities of external appearance, nutritional condition, posture, behavior and excretions. Body weight was recorded on day 0 of administration and on days 1, 3, 7 and 14 after administration.
- Necropsy of survivors performed: Yes, all animals were sacrificed after the 14-day observation period by exsanguination via the abdominal aorta under isoflurane anesthesia and necropsied. External appearance and organs/tissues in the cranial, thoracic and abdominal cavities were examined macroscopically.

Statistics:

For body weight, the mean value with standard deviation was calculated for each point measured for each dose step. The body weight gain during the observation period from day 0 of administration to day 14 after administration was determined and the mean value with standard deviation was calculated in the same manner.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

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