N-hexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because there was no GLP statement provided, and limited data on methods were reported, but the study seemed to be well-conducted.

Data source

Reference

Reference Type:

publication

Title:

The Toxicological Properties of Hydrocarbon Solvents

Author:

Hine, CH, and Zuidema, HH

Year:

1970

Bibliographic source:

Industrial Medicine, Vol. 39, No. 5, May 1970.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane

IUPAC Name:

C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane

Details on test material:

- Name of test material (as cited in study report): S-1
- Composition of test material, percentage of components: C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Type of wrap if used: saran wrap sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with damp towels
- Time after start of exposure: 4 hrs


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

Duration of exposure:

4 hrs

Doses:

up to 5.0 ml/kg

No. of animals per sex per dose:

3 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

method of Litchfield and Wilcoxen

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: 3.35 g/kg

Mortality:

No mortality was observed.

Clinical signs:

other: Animals showed signs of discomfort and were uncoordinated at the end of the exposure period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The 4-hr LD50 for dermal exposure in rabbits is > 5.0 ml/kg bw (3.35 g/kg).

Executive summary:

This study examined the dermal toxicity of the hexane. Doses of up to 5.0 ml/kg of test substance was placed on the shaved skin of 3 male rabbits. The test area was then covered with a saran wrap sleeve for 4 hrs. After the exposure period, the test substance washed off, and the animals observed for toxicity and mortality over the next 14 days. No animals died, however, they did show signs of discomfort and uncoordination after the exposure. The LD50 for dermal exposure is > 5.0 ml/kg (3.35 g/kg). The test substance is not classified as toxic under EU GHS guidelines.