Fatty acids, C16-22

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP-Guideline study, tested with the source substance stearic acid (CAS 57-11-4). 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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Stearic acid

EC Number:

200-313-4

EC Name:

Stearic acid

Cas Number:

57-11-4

Molecular formula:

C18H36O2

IUPAC Name:

stearic acid

Details on test material:

- Name of test material (as cited in study report): Edenor C 18 98/100 (stearic acid 98-100%)
- Physical state: A solid white substance, crystalline structure
- Analytical purity: 98-100%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Supplied by Winkelmann, Hannover, Germany
- Weight at study initiation: Mean body weights of male and female rats were 170 and 146 g, respectively
- Fasting period before study: 18 hours prior to dosing (feeding only)
- Housing: Same sex-groups of five Wistar rats were housed in type III Makrolon-cages containing soft wood granulated material
- Diet: A standard laboratory animal diet (Altromin for rats)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Purity: 99%


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed immediately after dosing and 1, 4 and 24 hours after dosing, then once every 24 hours thereafter for the rest of the observation period. Individual bodyweights were measured immediately prior to dosing and 24 hours after dosing as well as 7 and 14 days after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Female rats: no mortality occurred during the 14 days observation period
Male rats: one animal died on day 13 after dosing, all other animals survived the 14 days observation period

Clinical signs:

other: Clinical signs appeared approximately 20 minutes after dosing. Ruffled fur, strong salivation and very diminished activity. These clinical signs completely subsided within 24 hours after dosing

Gross pathology:

Swelling of the gastric mucosa. Rests of substance in stomach (surviving and death animals)