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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP, very low detail level, extremely low sensitivity of the study design (3-fold too short exposure, 4-fold too low concentration, 7-fold too short observation period and doubt whether macroscopic examination was performed) excluding conclusion on classification.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Department of Transportation Regulation 49 CFR 173.343, 1976.
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
yes

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder: Laboratory Supply Company, Indianapolis, Indiana
- Weight at study initiation: 236-273 g
- Fasting period before study: No

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The rats were exposed to the test compound in a 0.5 cm3 volume stainless steel inhalation chamber. The air flow through the chamber was
148 liters of air/min. The vapor of 2-Ethyl-n-hexyl nitrate was generated by heating the test compound in a glass flask while bubbling nitrogen
into the compound. The concentrations of the test compound in the chamber was calculated by determining the weight of the compound used and
dividing by the total air flow through the chamber during the test. As the stated air flow in the chamber, approximately 15 minutes is required to
reach equilibrium concentration. Therefore, a total exposure time of 75 minutes was used to allow a one-hour exposure to the equilibrium
concentration.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
75 min
Remarks on duration:
including equilibration time
Concentrations:
4.6 mg/L (nominal)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The animals were observed 24 and 48 hours following the exposure to determine the number of death that occurred.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LCLo
Effect level:
> 4.6 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
75 min

Applicant's summary and conclusion

Interpretation of results:
other: insufficient exposure excluding conclusion
Remarks:
Criteria used for interpretation of results: EU
Executive summary:

No death occured within 48h among ten female rats exposed to 2EHN vapour at 4.6 mg/L (nominal) averaged over 75 min of exposure (incl. equilibration time).

The extremely low sensitivity of the study design when compared to the applicable guideline (3-fold too short exposure, 4-fold too low concentration, 7-fold too short observation period and doubt whether macroscopic examination was performed) excludes any conclusion on classification.