2-ethylhexyl nitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No analytical certificate (no data on batch number and expiry date of the test substance), no data on GLP and experimental conditions. The very high tested dose enables a reliable conclusion.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substance Act.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl nitrate

EC Number:

248-363-6

EC Name:

2-ethylhexyl nitrate

Cas Number:

27247-96-7

Molecular formula:

C8H17NO3

IUPAC Name:

2-ethylhexyl nitrate

impurity 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

Molecular formula:

C8H18O

IUPAC Name:

2-ethylhexan-1-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Laboratory Supply Company, Indianapolis, Indiana
- Weight at study initiation: 200 to 275 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

10 mL/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:

Yes, but results were not indicated.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Mortality:

2 males and 1 female were found dead.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross abnormalities were noted at necrospy.

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 was expressed in mL/kg. The volume mass of the substance is 0.96 kg/L (0.96 g/mL). Therefore, when treating rats with 10 mL/kg, rats received 9.6 g/kg of substance, lowest limit of the LD50.