Fatty acids, C14-22, C16-24-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Jan -2 Feb 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16 and C18-22-unsatd., C16-18 and C18-unsatd. alkyl esters

EC Number:

292-792-1

EC Name:

Fatty acids, C16 and C18-22-unsatd., C16-18 and C18-unsatd. alkyl esters

Cas Number:

90990-29-7

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tuck & Sons Ltd, Battlesbridge, Essex, UK
- Weight at study initiation: 174 - 278 g (males and females)
- Fasting period before study: 16 - 20 h overnight
- Housing: 5 rats per cage in solid polypropylene cages, on softwood sawdust
- Diet: Rat Diet (Nottingham University, School of Agriculture, Nottingham, UK), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

Range finding study: 10 and 20 mL/kg bw (corresponding to 8700 and 17400 mg/kg bw, respectively, based on a relative density of 0.87 g/cm³)
Main study: 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³)

No. of animals per sex per dose:

Range finding study: 1
Main study: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed to record mortality and clinical signs 1/2, 1 and 4 hour(s) after dosing and then once daily for fourteen days. The body weights of all animals were recorded on Day 0 and Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

Based on the data of the dose range-finding study a dose level of 20 mL/kg bw was selected for the main test.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Based on:

test mat.

Remarks on result:

other: corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³

Mortality:

No mortality occured during the observation period.

Clinical signs:

No overt signs of toxicity were observed up to the end of the observation period.

Body weight:

No effect on body weight was noted.

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.

Conclusions:

In this acute oral toxicity study in rats a LD50 value of > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³) was found.