Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test substance was applied within a glass ring to the volar forearm of a volunteer and left on the skin for 5 min.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
n-hexane, analytical grade

Test animals

Species:
other: human

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
single dose, 1.5 ml on an area of 3.1 cm²
Duration of treatment / exposure:
5 min.
Observation period:
60 min.
Number of animals:
1 human volunteer

Results and discussion

In vivo

Results
Irritation parameter:
other: visual inspection
Time point:
other: 10-20 minutes
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
A slight transient erythema was observed after 10-20 minutes exposure to 1.5 mL n-hexane. Stinging and/or burning sensation reported by the volunteer. Application of 0.1 mL neat n-hexane did not cause clinical signs or affect blood flow.
Irritant / corrosive response data:
increased blood flow, slight erythema, stinging and/or burning sensation
fully reversible within 60 min.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Analogue substance n-hexane caused fully reversible skin irritation at a human volunteer.