Reaction mass of 4-Vinylcyclohexene, Cyclododeca-1,5,9-triene (1Z,5E,9E) and Cycloocta-1,5-diene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Conditions: standard acute inhalation toxicity study; nose-only

Principles of method if other than guideline:

Standard acute inhalation toxicity study; nose-only

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(1E,5E,9E)-cyclododeca-1,5,9-triene; (1Z,5Z)-cycloocta-1,5-diene; 4-ethenylcyclohex-1-ene

EC Number:

940-766-1

Molecular formula:

unspecified

IUPAC Name:

(1E,5E,9E)-cyclododeca-1,5,9-triene; (1Z,5Z)-cycloocta-1,5-diene; 4-ethenylcyclohex-1-ene

Details on test material:

- Name of test material (as cited in study report): Cycloocta-1,5-dien (constituent of registered reaction mass)
- Analytical purity: pure (not indicated)

Test animals

Species:

rat

Strain:

other: Crl:CD(R) BR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ORGANISMS:
- Source:
- Age: approximately 8 weeks
- Weight at study initiation: 268-292 g
- Number of animals: 6
- Controls: no

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose only

Vehicle:

other: houseline air

Details on inhalation exposure:

ADMINISTRATION:
- Type of exposure: single nose-only exposure
- Concentrations: measured at approximately 15-minute intervals by GC
- Type or preparation of particles: No particles. Chamber atmospheres were generated by vaporizing the test substance in a heated nitrogen stream and dilution with houseline air.
- Temperature, humidity in chamber: 23 +/- 2 °C, 50 +/- 10 %

Concentrations was measured at approximately 15-minute intervals by GC

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

1400, 2700, or 4300 ppm = 6.30, 12.1, or 19.3 mg/l

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

EXAMINATIONS:
mortality and response to stimuli during exposure; clinical signs and mortality immediately following exposure; body weight and clinical signs daily
thereafter for 14 days (during weekends only when warranted by the health status of the rats).

Statistics:

Evaluation with simple statistics at p <= 0.05.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

12 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

2 700 ppm

Based on:

test mat.

Exp. duration:

4 h

Mortality:

- 1400 ppm: 0/6
- 2700 ppm: 1/6 night after exposure
- 4300 ppm: 4/6 during exposure

Clinical signs:

other: - Response to external sound stimuli: Absent for all animals after 3 hours exposure - Immobility: 2 surviving rats at 4300 ppm and 4 rats at 2700 ppm - Ataxia: 3 rats at 1400 ppm - Ocular discharge, ruffled fur, or stained perineum: Up to 4 days follow

Body weight:

Losses of 4-14% were recorded the day after exposure, followed by body weight gains in all animals.

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the present test conditions, the test item is considered slightly toxic in an acute inhalation toxicity study.

Executive summary:

Three groups of 6 male rats each were exposed nose-only for a single, 4 hour period to vapors of the test item in air at chamber vapor concentrations of 1400, 2700 or 4300 ppm. Mortality was 0/6, 1/6 and 4/6 at 1400, 2700 and 4300 ppm respectively. By 3 hours into the exposure all rats failed to respond to external sound stimuli. At the end of exposure, the 2 rats at 4300 ppm and 4 rats at 2700 ppm were immobile. Threee rats at 1400 ppm exhibited ataxia. Other clinical signs of toxicity observed after exposure: ocular discharge,  lethargy, irregular respiration. Ocular discharge, ruffled fur or stained perineum were observed up to 4 days following exposure. The test item is considered slightly toxic.