2-ethylhexanal

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: Study is well conducted and acceptable for endpoint evaluation. No guideline was followed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1991

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- no guideline mentioned and limited reporting
- remark: study based on dermal toxicity and skin studies

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexanal

EC Number:

204-596-5

EC Name:

2-ethylhexanal

Cas Number:

123-05-7

Molecular formula:

C8H16O

IUPAC Name:

2-ethylhexanal

Details on test material:

- Name of test material (as cited in study report): 2-ethylhexyl aldehyde
- Physical state: not reported
- Analytical purity: not reported

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

no details reported
TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation (g): M 251-264, F 205-218
- Fasting period before study: not reported
- Diet (e.g. ad libitum): not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not reported
- % coverage: not reported
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24h exposure residual test substance was washed off with running water
- Time after start of exposure:

TEST MATERIAL
- Amount applied (volume or weight with unit): limit dose 20 ml/kg bw (16440 mg/kg bw)
- Constant volume or concentration used: yes

Duration of exposure:

not reported

Doses:

undiluted substance administered
- Volume: 20 ml/kg bw - calculated 16440 mg/kg bw (density at 20°C 822 mg/ml)

No. of animals per sex per dose:

5 animals per sex and dose

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 440 mg/kg bw

Remarks on result:

other: no mortalities at limit dose

Mortality:

no mortality observed

Clinical signs:

- erythema was observed in all animals at the application site after termination of exposure period
- by day4: all male animals are without substance related effects while females continue showing erythema until day8

Body weight:

normal body weight gain in all animals

Gross pathology:

not reported

Other findings:

- Other observations: no signs of percutaneous adsorption

Applicant's summary and conclusion

Executive summary:

The study is reliable with acceptable restrictions mostly due to limited documentation (e.g. body weight only determined for dose calculation prior to application). A single limit dose of 20 ml/kg bw (calculated 16440 mg/kg bw) of the test substance was applied on rats for 24h. 5 animals per sex were used in the. No mortality and no substance related clinical findings were reported within, besides erythema occurrence at the application site after termination of exposure. Erythema formation was reversible within 14 days. No signs of percutaneous adsorption were observed.

2-ethylhexanal is practically nontoxic when in contact with skin.