Fatty acids, tall-oil, compds. with diethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 12, 1989 to February 14, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

EC Number:

271-653-9

EC Name:

Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Cas Number:

68603-38-3

Molecular formula:

The alkyl chain length of the amide ranges between 16 and 18 carbon atoms

IUPAC Name:

Amides, C16-18 (even numbered) and C18-unsatd., N, N-bis(hydroxyethyl)

Constituent 2

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

glycerol

impurity 1

Reference substance name:

2,2'-iminodiethanol

EC Number:

203-868-0

EC Name:

2,2'-iminodiethanol

Cas Number:

111-42-2

Molecular formula:

C4H11NO2

IUPAC Name:

2,2’-iminodiethanol

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Bor:WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Weight at study initiation: 249 g
- Fasting period before study: > 16 h
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: R10 Alleindiät for rats, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5-8 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 60 +/- 5%
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 3.09 cm3/kg

Doses:

3000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of clinical observation: Continuously up to 6 h post-treatment and subsequently once daily for 14 d
- Frequency of weighing: Pre-treatment , then on Days 1, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: All animals were in resting position 30 minutes after dosing. Three had slightly rough fur. Thirty minutes later, no symptoms were seen anymore.

Gross pathology:

Six animals showed local thickenings of the mucous membrane of the forestomach; in three of these animals, the mucous membrane of the stomach was slightly reddened.

Other findings:

None.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 of the test substance in rats was found to be >3000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the test substance, C16-18 and C18-unsatd. DEA, in Bor: WISW rats according to OECD Guideline 401. A group of 20 fasted animals (10 males and 10 females) were given a single oral dose of 3000 mg/kg bw undiluted test substance. The animals were observed for 14 d then sacrificed and subjected to gross pathological examination. There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals. Under the study conditions, the LD50 of the test substance in rats was found to be >3000 mg/kg bw (Mürmann, 1990).