Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

cited as Directive 92/69/EEC Part B, method B.1 bis as of 29.12.1992

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

61791-19-3

Cas Number:

61791-19-3

IUPAC Name:

61791-19-3

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: Tierzucht Schoenwalde GmbH, D-16352 Schoenwalde
- Age at study initiation: young adult rats
- Weight at study initiation: 127 - 156 g
- Fasting period before study: approximately 18 hours prior to dosing. After dosing diet was withheld for a further 3 hours.
- Housing: macrolone type I I I , floor area 810 cm2, 2 or 3 animals each cage
- Diet: pelleted complete rodent diet "Altromin 1314" from Altromin GmbH, D-32791 Lage, Lippe, was available ad libitum
- Water: free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: 7 days befor administration under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C ± 3 °C
- Humidity (%): 55 % ± 15 %
- Air changes: 10 times/hour
- Photoperiod : 12 hours light and 12 hours darkness. Light was on from 06.00 am to 06.00 pm.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/ kg bw
- Justification for choice of vehicle: common vehicle

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), 48 hours and 7 days after application and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examination: clinical signs

Results and discussion

Preliminary study:

One female rat the test substance was given in a 2000 mg/kg bw dose. Slight signs of toxicity were observed in this rat.
One, 3 and 6 hours after the application of the test article a pinched abdomen and piloerection were seen in this animal. On days 1 and 2 piloerection only was observed. From day 3 until the end of the observation period no abnormalities were seen. The post mortem inspection revealed no abnormalities.
On the basis of the results from the sighting study the main study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: One, 3 and 6 hours after the application of the test article a pinched abdomen and piloerection were seen in all animals. On day 1 only piloerection was observed in all animals. From day 2 until the end of the observation period no abnormalities were seen

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.