5-ethyl-1,3-dioxane-5-methanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 June 1992 to 27 Aug 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-ethyl-1,3-dioxane-5-methanol

EC Number:

225-967-8

EC Name:

5-ethyl-1,3-dioxane-5-methanol

Cas Number:

5187-23-5

Molecular formula:

C7H14O3

IUPAC Name:

(5-ethyl-1,3-dioxan-5-yl)methanol

Test material form:

liquid

Specific details on test material used for the study:

Batch 9201; clear / colourless liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: Møllegaard Breeding Centre ApS, Ejby, DK-4623 Lille, Skensved
Age at study initiation: 6 - 7 weeks old
Weight at study initiation: 146 -163 g
Fasting period before study: Rats were fasted for approximately 18 hours prior to dosing
Housing: Housed in Macrolone type III cages (42 x 26 x 15cm), with 2 or 3 to a cage. Males and females were kept separated
Diet (e.g. ad libitum): Complete rodent diet "Altromin 1314" ad libitum
Water (e.g. ad libitum): Drinking water acidified with hydrochloric acid to pH 2.5 ad libitum
Acclimation period: 5 days

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

IN-LIFE DATES: No information provided.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water.

Details on oral exposure:

VEHICLE- Concentration in vehicle: 2000 mg/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: 10ml/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:

2000 mg/kg body weight

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: Bodyweights were recorded on Day 0, Day 7 and Day 14. Observations on clinical signs of toxicity were made 1, 2, 3 and 6 hours and daily thereafter from Day 1 to 14.- Necropsy of survivors performed: Any rats found dead during the 14 day observation period were subjected to a autopsy examination. All surviving rats were subjected to gross necropsy examination at the end of the 14 day observation period.- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No information provided.

Statistics:

Not required

Results and discussion

Preliminary study:

A dose-range finding study was conducted at a dose level of 2000 mg/kg bw

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died during the treatment.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The surviving rats had a normal body weight gain during the study period.

Gross pathology:

Autopsy of the rat that died from the treatment revealed no pathological findings that could be attributed to the treatment. No gross pathological findings related to the treatment wee observed following autopsy of the surviving rats.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study, the oral LD50 of CTF was >2000 mg/kg bw.

Executive summary:

The acute oral toxicity of CTF in rats was determined according to the method recommended in OECD Guideline 401. CTF was administered orally by gavage to 5 male and 5 female Wistar rats at a concentration of 2000 mg/kg bw. The test animals were observed for a period of 14 days following exposure and observations were made at regular intervals, including observations on body weight, clinical signs and any clinical signs of toxicity. All test animals were subjected to a gross necropsy at termination on day 14. With only one female rat found dead during the course of the exposure, the oral LD50 was above 2000 mg CTF/kg body weight under the conditions of this study.