3-ethyloxetane-3-methanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16th April 1998 to 6th May 1998.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-ethyloxetane-3-methanol

EC Number:

221-254-0

EC Name:

3-ethyloxetane-3-methanol

Cas Number:

3047-32-3

Molecular formula:

C6H12O2

IUPAC Name:

(3-ethyloxetan-3-yl)methanol

Specific details on test material used for the study:

- Name of test material (as cited in study report): TMP oxetane
-CAS No 3047-32-3
- Physical state: Colourless liquid.
- Analytical purity: No information provided.
- Lot/batch No.: JNS 980121 F 1-3
- Expiration date of the lot/batch: No information provided.
- Storage condition of test material: Stored in a refrigerator at 2 - 8°C 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: Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved.
- Age at study initiation: 6 - 7weeks
- Weight at study initiation: 147 - 172g
- Fasting period before study: Fasted overnight prior to dosing.
- Housing: HOused in groups of 2 or 3 in transparent polycarbonate cages (Macrolon type II) with a floor area of 810cm2. Males and females were grouped separately.
- Diet (e.g. ad libitum): A pelleted complete rodent diet (Altromin 1314) ad libitum.
- Water (e.g. ad libitum): Free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.

IN-LIFE DATES: From: To: Not documented.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sterile water.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000mg/kg body weight.
- Amount of vehicle (if gavage): No information provided.
- Justification for choice of vehicle: No information provided.
- Lot/batch no. (if required): No information provided.
- Purity: No information provided.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.

DOSAGE PREPARATION (if unusual): No information provided.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No information provided.

Doses:

Test animals were administered a single dose.

No. of animals per sex per dose:

5 animals per sex per dose.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight was measured on days 1, 8 and 15. Each rat was observed for clinical signs at 1, 3 and 6 hours after administration and daily thereafter for 14 consecutive days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No additional observations recorded.

Statistics:

No information provided.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities recorded.

Clinical signs:

other: Seven animals showed mild signs of toxicity, including ataxia, piloerection and subdued behaviour from 1 - 3 hours after dosing: piloerection in 7 animals, piloerection and ataxia in 5 animals and subdued behaviour in 2 animals. During the rest of the ob

Gross pathology:

No abnormalities were recorded.

Other findings:

No additional findings recorded.

Any other information on results incl. tables

Body Weight: Group Mean:

Dose (mg/kg bw)	Sex	Day 1			Day 2			Day 3
		Mean	SD	N	Mean	SD	N	Mean	SD	N
2000	Male	163.5	8.05	5	219.2	13.79	5	254.6	15.5	5
2000	Female	153.4	5.39	5	176.9	7.29	5	183.8	7.40	5

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the oral LD50 in rats was found to be above 2000mg TMP oxetane/kg body weight.

Executive summary:

The acute oral toxicity in rats was determined in accordance with OECD Guideline 420 and EEC Guideline B.1.bis "Acute Toxicity (Oral). The study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg TMP oxetane/kg body weight. All animals survived the treatment. Seven animals showed mild signs of toxicity, including ataxia, piloerection and subdued behaviour from 1 - 3 hours after dosing: piloerection in 7 animals, piloerection and ataxia in 5 animals and subdued behaviour in 2 animals. During the rest of the observation period, no signs of toxicity were observed. The rats had a normal body weight gain during the study period.

Under the experimental conditions of this study, the oral LD₅₀in rats was found to be above 2000mg TMP oxetane/kg body weight.