2-ethylhexyl nitrate

Acute Toxicity: inhalation

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.

Materials and methods

Test guideline

Qualifier:

according to guideline

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 or test system 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.