Fatty acids, C18-unsatd., compds. with triethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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:

2-[bis(2-hydroxyethyl)amino]ethyl oleate

EC Number:

233-621-2

EC Name:

2-[bis(2-hydroxyethyl)amino]ethyl oleate

Cas Number:

10277-04-0

Molecular formula:

C24H47NO4

IUPAC Name:

2-[bis(2-hydroxyethyl)amino]ethyl octadec-9-enoate

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Breeding
- Age at study initiation: approx 7 weeks (males); approx. 8 weeks (females)
- Weight at study initiation: 171 +/- 3 g (males); 169 +/- 4 g (females)
- Fasting period before study: approx 16 hours pre dosing
- Housing:macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Doses:

2000 mg/kg/bw

No. of animals per sex per dose:

5 male
5 female

Control animals:

no

Details on study design:

The test item (Vehicle: Sesame oil, dose level was 2000 mg/kg/bw) was applicated via gavaging. The observation peroide was 14 days. The occurence of symptomes was recorded twice a day (forenoon and afternoon) during the week. On the week-end and on public holidays the occurence of symtoms was recorded once a day. During this time periode the weight of the animals was recorded once a week.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

male: 0
female: 0

Clinical signs:

other: male: unspecific symptoms, i.e. stilted gait and reduced spontaneous activity occured 30 min - 2 hours after application of the test item female: no toxic symptoms were observed during the whole study period.

Gross pathology:

male and female: no macroscopic effects were observed

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD 50 of the test item is >2000 kg/mg/bw.

Executive summary:

The acute oral toxicity of the test item was investigated in 5male and 5 female Wistar rats using sesame oil as vehicle. The study was performed according to OECD test guideline 401 and followed the principles of GLP. The animals were administered the test compound by single-dose gavage at a dose-level of 2000 mg/kg body weight. The observation period was 14 days. No deaths occurred during the study. Beside unspecific findings like stilted gait and reduced spontaneous activity shortly after dosing, no clinical signs of intoxication were observed during the course of the study. Body weight development was normal and within the range commonly recorded for this strain and age. At necropsy no macroscopic findings were recorded. Based on the findings of this limit-test the median lethal dosage (LD50) of the test item in the rat is greater than 2000 mg/kg body weight.