Fatty acids, C14-18 and C16-18-unsatd.

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:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Bewertung Wassergefährdender Stoffe, II Bestimmung der akuten, oralen Säugetiertoxizität, Ad-hoc-Arbeitsguppe I (Obmann Dr. Niemits), LTwS, nr. 10, September 1979

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C14-18 and C16-18-unsatd.

EC Number:

266-930-6

EC Name:

Fatty acids, C14-18 and C16-18-unsatd.

Cas Number:

67701-06-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Fatty acids, C14-18 (even numbered) and C16-18-unsatd.(even numbered)

Details on test material:

- Name of test material (as cited in study report): PRIFAC 7920
- Physical state: solid
- Analytical purity: > 98 % saturated and unsaturated fatty acids
- Melting point: 38 - 43 °C
- Boiling point: > 200 °C
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG.
- Age at study initiation: 10 weeks
- Weight at study initiation: mean 323 g (males), 205 g (females)
- Fasting period before study: overnight (prior to dosing) until approximately 3.5 hours after administration
- Housing: in groups of same sex in polycarbonate cages containing purified sawdust as bedding material
- Diet: Standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, the Netherlands)
- Water: Tap-water; ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Doses:

2000 mg/kg bw

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: Observations were performed on the day of dosing (approximately 0.05, 2 and 4 hours after dosing) and once daily thereafter for 14 days; individual bodyweights were measured weekly (0, 7 and 14 days)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No moratality occurred

Clinical signs:

other: Apart from one female rat that showed bloody eye encrustation (on day 0) and dacryorrhoea (on day 1), no clinical signs of possible toxicity were seen during the s 14 days observation period.

Gross pathology:

Macroscopic examination of animals at termination revealed no abnormalities