Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Performed under GLP following a method similar to a recognised guideline; limited test material characeterisation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Molecular formula:

C12H18O

IUPAC Name:

Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Test material form:

other: liquid

Details on test material:

- Physical state: liquid
- Storage condition of test material: The test article was stored in the container provided by the sponsor at ambient room temperature and humidity.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier.
- Age at study initiation: Not reported
- Weight at study initiation: 241 - 267 g
- Fasting period before study: 16-20 hours prior to doing.
- Housing: Test animals were housed 5/cage in suspended wire mesh cages.
- Diet (e.g. ad libitum): ad libitum except for 16-20 hours prior to doing.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was administered orally, one time, by syringe and dosing needle on a g/kg basis.

Doses:

5.0 g/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

A total of 5 animals died (3 on day 1 and 2 on day 2).

Clinical signs:

other: Principal toxic manifestations included lethargy, ataxia, piloerection, ptosis and coma. Except for isolated instances of chromodacryorrhea and chromorhinorrhea, the survivors were normal from Day 3 to Day 14.

Gross pathology:

Necropsy of the deaths revealed abnormalities of the heart, lungs, gastrointestinal tract, kidneys and urinary bladder. Necropsies of the survivors
were normal.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute oral median lethal dose (LD50) of the test material in male Wistar rats was considered to be 5000 mg/kg body weight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Wistar strain of rat. The study was performed under GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, after fasting for 16 -20 hours, once only by gavage. 10 male test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days.

Mortality occurred on Days 1 and 2 of the study. Principal toxic manifestations included lethargy, ataxia, piloerection, ptosis and coma. Except for isolated instances of chromodacryorrhea and chromorhinorrhea, the survivors were normal from Day 3 to Day 14. Necropsy of the deaths revealed abnormalities of the heart, lungs, gastrointestinal tract, kidneys and urinary bladder. Necropsies of the survivors VJere normal. The acute oral median lethal dose (LD50) of the test material in the male Wistar strain rat is 5000 mg/kg bodyweight.