Oxazolidine, 3-butyl-2-(1-ethylpentyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-11-10 to 1995-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 17th 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31st 1992

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-660-0

EC Name:

-

Cas Number:

165101-57-5

Molecular formula:

C14H29NO

IUPAC Name:

3-butyl-2-(heptan-3-yl)-1,3-oxazolidine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd
- Weight at study initiation: male: 201-283 g; female: 165-190 g
- Fasting period before study: approximately 18 hours prior to dosing until 3 hours after dosing
- Housing: five animals per sex in suspended stainless steel mesh cages (dimensions 55 x 34 x 20 cm)
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

dessicated

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle: 10 mL/kg bw
- Lot/batch no.: 11362

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

five animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once within one-half hour of dosing, four times within four hours of dosing, twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
- body weight: was done on day -1 (day before dosing), day 1 (day of dosing), day 8 and day 15

Statistics:

NA

Results and discussion

Preliminary study:

The preliminary study was undertaken to allow selection of the discriminating dose level for the main study. The discriminating dose level is the highest of four dose levels (5, 50, 500 or 2000 mg/kg) that is non-lethal in the main study. The preliminary investigation was conducted using groups of two fasted female rats dosed at 500 or 2000 mg/kg body weight.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died following single oral administration of Incozol 2 at 2000 mg/kg body weight.

Clinical signs:

other: There were no overt signs of reaction to treatment.

Gross pathology:

No macroscopic changes were apparent during necropsy of rats killed on day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity study on Sprague-Dawley rats treated with Incozol 2 resulted in a LD50 of above 2000 mg/kg bw.

Executive summary:

This study was conducted to assess the acute oral toxicity of Incozol 2 in the rat (Sprague-Dawley). The method followed was in compliance with Method B.1 bis and OECD TG 420. Five male and five female fasted rats were given the test item as a single dose by oral gavage at the limit dose level of 2000 mg/kg body weight. The test item was dispersed in corn oil and administered at a dose volume of 10 mL/kg bw on day 1. All animals were killed on day 15 and subsequently underwent a full necropsy. No animal died. There were no overt signs of reaction to treatment. All rats achieved body weight gains during the first and second week of the study. No macroscopic changes were apparent during necropsy of rats killed on day 15. The acute oral minimum lethal dose of Incozol 2 to rats was found to exceed 2000 mg/kg body weight (Corning Hazleton, 1995).