Oligomerisation products of ethylene oxide with reaction products of rape oil and ethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 5 August 1991 to 28 October 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: clear yellow liquid
- Stability under test conditions: stable
- Storage condition of test material: Between 20-30ºC in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 197-218 g
females: 155-169 g
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/Kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality

Mortality:

No mortality occurred during the study period

Clinical signs:

other: No clinical signs of ill health or behavioural changes were seen during the test

Gross pathology:

Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities

Any other information on results incl. tables

INDIVIDUAL ANIMAL OBSERVATIONS - MALES

Dose Level (mg/kg)	Observations	Number showing effects during day of exposure (hours)			Number showing effects during day of observation														Total mortality
		0,05	2,1	4,15	2	3	4	5	6	7	8	9	10	11	12	13	14	15
2000	No abnormalities	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5
	Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5

INDIVIDUAL ANIMAL OBSERVATIONS - FEMALE

Dose Level (mg/kg)	Observations	Number showing effects during day of exposure (hours)			Number showing effects during day of observation														Total mortality
		0,05	2,1	4,15	2	3	4	5	6	7	8	9	10	11	12	13	14	15
2000	No abnormalities	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5
	Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/Kg body weight.

Executive summary:

This study was entitled "Assessment of acute oral toxicity with the substance in the rat". The study was carried out in accordance with the OECD Guideline No. 401, “Acute Oral Toxicity” and EEC Directive 84/449/EEC, Par B.1, “Acute Toxicity-Oral”. No clinical signs of ill health or behavioural changes were observed during the study and no macroscopic abnormalities were seen at necropsy. The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/kg body weight.

The substance cannot be classified and has no obligatory labelling requirement.