Fatty acids, sunflower-oil, conjugated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

18 Feb - 03 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP-Guideline study, tested with the source substance oleic acid (CAS 112-80-1). In accordance with the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that the study was conducted with a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

Oleic acid

EC Number:

204-007-1

EC Name:

Oleic acid

Cas Number:

112-80-1

Molecular formula:

C18H34O2

IUPAC Name:

octadec-9-enoic acid

Details on test material:

- Name of test material (as cited in study report): Priolene 6900 (Oleic acid)
- CAS No.: 112-80-1
- Physical state: liquid
- Cloud point: max 7 °C
- Purity: >98% saturated and unsaturated fatty acids
- Specific gravity: 0.9 (20 °C)
- Boiling point: > 200 °C
- Flash point: approx. 180 °C
- Vapour pressure: < 1 mbar (20 °C)
- Stability: Stable at storage conditions
- Storage condition of test material: at ambient 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 (SPF- quality)
- Age at study initiation: 8 weeks
- Weight at study initiation: 120 - 250 g (range)
- Fasting period before study: overnight
- Housing: individually in polycarbonate cages containing purified sawdust
- Diet (ad libitum): standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden)
- Water (ad libitum): tap-water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 (air-conditioned)
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- gavage using a stainless steel stomach cannula attached to a disposable plastic syringe
- test substance was heated to 37°C until the solid test substance particles were melted

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: on the day of dosing approx. once every two hours and once daily thereafter for 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

macroscopic examination of animals at termination did not reveal any abnormalities that were considered to be treatment related

Any other information on results incl. tables

Under the conditions used in this study, it is concluded that the test substance has no toxic effect when administered as a single oral dose to the rat at a level of 2000 mg / kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU