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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Test substance was applied for 24 hrs.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.