1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1990-09-06 to 1990-09-20

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)

Version / remarks:

February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 84/449/EEC, September 19, 1984

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate

EC Number:

411-700-4

EC Name:

1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate

Cas Number:

140921-24-0

Molecular formula:

C32H62N4O6

IUPAC Name:

2-[3-(heptan-3-yl)-1,2-oxazolidin-2-yl]ethyl N-{6-[({2-[3-(heptan-3-yl)-1,2-oxazolidin-2-yl]ethoxy}carbonyl)amino]hexyl}carbamate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Strain: SPF-bred Wistar rats (strain Bor: WISW (SPF Cpb)
- Age at study initiation: young-adult. At the start of the experiment, male rats were about 7 weeks old and females 10 weeks, based on their body weights.
- Weight at study initiation: The mean initial weight of males and females were 173 g and 167 g, respectively. The mean deviation in animal weights was less than 20 %.
- Housing: The rats were housed in groups of 5 animals each, under conventional conditions, in Makrolon type III cages on low-dust wood granules
- Nutrition: The animals received fixed-formula standard diet Altromin® 1324 pellets and tap water ad libitum. There were feeding troughs fitted in the cage lids as feed containers. Water was offered in polycarbonate bottles holding approximately 700 mL. The nutritional composition and the contaminant content of the standard diet were routinely spot-checked and analysed. The tap water was of drinking quality. The results of the feed and water analyses have been filed. The data available produced no evidence of any influence on the study objective.
From approximately 16 hours prior to application up to 4 hours thereafter feed was withdrawn, all the other time it was available ad libitum. Tap water was available ad libitum during the entire study period.
- Acclimation period: at least 4 days.
- Other: Females were nulliparous and not pregnant. The condition of the animals' health was checked before the start of experiment. Only healthy animals, without any clinical signs, were included in the study.

ENVIRONMENTAL CONDITIONS
- Temperature: room temperature (22 ± 2 °C)
- Humidity: about 50 ± 10 %
- Air changes: approximately ten air changes per hour
- Photoperiod: 12-hour light/dark cycle (artificial light from 6 a.m. to 6 p.m. CET)
- Other: All animals of this study were kept in one animal room. For reasons of capacity, animals from other toxicological studies were temporarily housed in the same animal room. Mixing up of the animals or mutual influence was avoided by appropriate organisation of the operations.

IN-LIFE DATES: From: 1990-09-06 To: 1990-09-20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Remarks:

1,2-propanediol

Details on oral exposure:

DOSE VOLUME APPLIED:
Application volume of 10 mL/kg bw

Doses:

Rationale for the selection of the dose:
According to OECD Guideline 401 of Feb. 24, 1987, sufficient assessment of acute oral toxicity is achieved as a rule, even if no substance related lethality occurs at a dose of 2000 mg/kg body weight. The following dose was administered: 2000 mg/kg body weight.

No. of animals per sex per dose:

5 male and 5 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration (day 0), after one week and at the end of the 14-day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the 14-day observation period.

Clinical signs:

other: All males and one female showed rough coat as a sign of intoxication after single administration of 2000 mg/kg. Two males additionally displayed increased salivation and apathy. The signs appeared approximately half an hour after the application, were of

Gross pathology:

Necropsy findings: The animals sacrificed at the end of study did not show any noticeable gross pathological findings.
The following signs of intoxication were observed: rough coat, increased salivation and apathy.

Other findings:

- Analytical investigations:
The analytical investigations into the stability of the test compound showed that it was stable for the duration of use in the concentration range employed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for male and female rats was greater than 2000 mg/kg bw.

Executive summary:

Acute toxicological investigations with male and female Wistar rats were conducted after oral administration (gavage) of the test substance in accordance with OECD guideline 401. The LD50 for male and female rats was determined to be greater than 2000 mg/kg bw and was not exactly determined. The following signs of intoxication were observed: rough coat, increased salivation and apathy. The body weight development of male and female rats was not affected. No animal died during the 14-day observation period. None of the animals sacrificed at the end of study showed any unusual gross pathological features.