1,3-dioxepane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

yes

Remarks:

; only 7 days observation period (14 days recommended by OECD guideline); body weights of the animals were not recorded at test ending.

Principles of method if other than guideline:

BASF test, in principle comparable to the OECD Guideline 401 (1987)

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dioxepane

EC Number:

208-015-6

EC Name:

1,3-dioxepane

Cas Number:

505-65-7

Molecular formula:

C5H10O2

IUPAC Name:

1,3-dioxepane

Details on test material:

Butandiolformal (1,3-Dioxacycloheptane)
Purity 99.99%
Physical state: liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Designation: US-Ratten
Source: no data
Age at test initiation: no data
Bodyweight range at test initiation: males 134-198 g, females 150-182g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Traganth

Details on oral exposure:

The test substance was given to the animals as aqueous emulsion using Traganth as vehicle at following concentrations: 2%, 20% and 30%.
The 30% test solution served for preparation of the 3.2, 4.0, 5.0 and 6.4 ml/kg bw dose levels;
The 20% test solution served for preparation of the 1.6 ml/kg bw dose level;
The 2% test solution served for the preparation of the 0.2 ml/kg bw dose level.
The application volume was as follows:
- 21.3 ml/kg bw for the 6.4 ml/kg bw group,
- 16.6 ml/kg bw for the 5.0 ml/kg bw group,
- 13.3 ml/kg bw for the 4.0 ml/kg bw group,
- 10.6 ml/kg bw for the 3.2 ml/kg bw group,
- 8.0 ml/kg bw for the 1.6 ml/kg bw group,
- 10.0 ml/kg bw for the 0.2 ml/kg bw group.

Doses:

Original doses:
0.2, 1.6, 3.2, 4.0, 5.0 and 6.4 ml/kg bw
Doses in mg/kg bw (according to a density of 1.005g/cm3):
201, 1608, 3216, 4020, 5025, 6432 mg/kg bw

No. of animals per sex per dose:

10 animals/sex/group were used

Control animals:

no

Details on study design:

The animals received a single application of the test material by gavage. Thereafter, they were observed over a period of 7 day for mortality and clinical symptoms of toxicity. At the end of the observation period, the animals were sacrificed for the purpose of necropsy.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 523 mg/kg bw

Remarks on result:

other: (original reported value: 4.5ml/kg bw)

Mortality:

Mortalities were as follows:
201 mg/kg bw: none (0/20)
1608 mg/kg bw: none (0/20)
3216 mg/kg bw: none (0/20)
4020 mg/kg bw: 5/20 (4 females and 1 male)
5025 mg/kg bw: 17/20 (10 females and 7 males)
6432 mg/kg bw: 20/20

Time point of death:
In the 6432 mg/kg bw group, all mortalities occurred within the first 24 hours following treatment;
In the 5000 and 4000 mg/kg bw groups, all mortalities occurred within 48 hours following treatment.

Clinical signs:

other: At 201 and 1608 mg/kg bw: piloerection, labored respiration, chewing, and in some cases, slightly staggering gait were reported; these signs disappeared within 1 to 2 days. At 3216 mg/kg bw: severe staggering gait, apathy, side and prone position, and dys

Gross pathology:

Necropsy of those animals that survived and were sacrificed at the end of the observation period of 7 days revealed no abnormalities.
Necropsy of the rats that died mainly revealed bloody lungs partly with edema, as well as serous contents in the thorax. In some cases, liver congestion with questionable fatty degeneration and thightly filled urinary bladder were seen.