Fatty acids, C8-18 and C18-unsatd.

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:

Guideline study, tested with the source substance fatty acids C8-18 (CAS 90990-08-2). 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:

yes

Remarks:

Institut für Toxikologie, Henkel KgaA

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-18

EC Number:

292-769-6

EC Name:

Fatty acids, C8-18

Cas Number:

90990-08-2

IUPAC Name:

90990-08-2

Details on test material:

- Name of test material (as cited in study report): Carbonfettsäure (Kokosölfettsäure C 8 - 18)
- Physical state: solid, white
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Hannover, Germany
- Weight at study initiation: mean 167 g (males), 133 g (females)
- Fasting period before study: 18 h, but water ad libitum
- Housing: in groups of 5/sex in Makrolon Type III cages
- Diet (e.g. ad libitum): standard laboratory diet (Altromin Haltungsdiät für Ratten); ad libitum
- Water (e.g. ad libitum): 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:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 20 ml/kg bw


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

5000 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 immediately and 1, 4 and 24 hours after dosing, then every 24 hours; weighing prior to dosing and 24 hours, 7 and 14 days after dosing
- 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:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: 20 min after dosing reduced activity and ruffled fur was noted. After 24 hours animals were free of symptoms.

Gross pathology:

- Males: swelling of stomach mucosa
- Females: swelling of stomach mucosa and with partial inflammation of the intestine