2-ethylhexyl nitrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Only 4 instead of 5 tested animals + unknown shaved area surface (cm2) + no mention of application under gauze + no detail on investigations (unknown whether any post-mortem examination done) + number of deaths not indicated = doubtful sensitivity and lack of details. The skin was abraded before treatment. However the moderate skin penetration (see 7.1) and the absence of acute oral toxicity imply an absence of dermal toxicity.

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:

no

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:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Small Stock Industries, Pea Ridge, Arkansas
- Age at study initiation: young adults
- Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not indicated
- % coverage: not indicated
- Type of wrap if used: rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: just after removal of the rubber dams

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg

Duration of exposure:

24 hours

Doses:

5 mL/kg

No. of animals per sex per dose:

4 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: not indicated
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:

Not indicated

Effect levels

Sex:

not specified

Dose descriptor:

LDLo

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

Not indicated.

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LDLo of the test substance after skin exposure during 24 hours is > 5 mL/kg. According to the volume mass of the test substance (0.96 kg/L), the LDLo of the test substance under the experimental conditions of the study is > 4.8 g/kg.