N-hexane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Test substance was applied for 24 hrs.

GLP compliance:

no

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

Details on test animals or test system and environmental conditions:

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: both intact and abraded shaved skin was tested

Duration of treatment / exposure:

24 hrs

Observation period:

24 and 72 hrs

Number of animals:

6 males

Details on study design:

TEST SITE
- Type of wrap if used: gauze

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hrs

Score:

1.92

Max. score:

3

Reversibility:

no data

Irritant / corrosive response data:

All six rabbits showed irritation ranging from a score of 1 to 3 on both intact and abraded skin.

Applicant's summary and conclusion

Conclusions:

The primary dermal irritation index (PDII) was 1.92 which is calculated from the average erythema score and the average oedema score. Additionally, the exposure period was 24 hours.

Executive summary:

This study examined the potential of the test substance hexane to cause irritation to skin. Test substance was applied to both intact and abraded skin of 6 male rabbits. The test area was covered with gauze for 24 hrs. After the exposure period, the animals were scored for irritation at 24 and 72 hrs after start of exposure. The primary dermal irritation index (PDII) was 1.92 which is calculated from the average erythema score and the average oedema score.