Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1996
Reference Type:
publication
Title:
Robust summary and test plan for 1,5-cyclooctadiene with cover letter dated 11 Dec 2002
Author:
DuPont Safety, Health & Environmental Excellence Center, Wilmington (Del., USA)
Year:
2002
Bibliographic source:
Quelle U.S. EPA 37 pp

Materials and methods

Principles of method if other than guideline:
Method: other: See Test Conditions: standard acute inhalation toxicity study; nose-only
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: other TS: 1,5-cyclooctadiene, purity > 99%

Test animals

Species:
rat
Strain:
other: Crl:CD(R) BR
Sex:
male
Details on test animals 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 %
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Concentrations was measured at approximately 15-minute intervals by GC
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
Key result
Sex:
male
Dose descriptor:
other: ALC (approximate lethal concentration)
Effect level:
ca. 12 - ca. 19 mg/L air
Exp. duration:
4 h
Mortality:
- 1400 ppm: 0/6
- 2700 ppm: 1/6 night after exposure
- 4300 ppm: 4/6 during exposure 
Clinical signs:
- 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  following exposure
- Lethargy, irregular respiration: Only on day of exposure
- No other clinical signs; all clinical signs reversible within 4 days
Body weight:
Body weights: Losses of 4-14% were recorded the day after exposure,  followed by body weight gains in all animals.
Gross pathology:
no data
Other findings:
no other findings

Any other information on results incl. tables

no further results

Applicant's summary and conclusion

Conclusions:
Under the present test conditions, 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.

On an acute inhaltion basis, test item is considered slightly toxic.