Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: data from collection of data
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:
Acute exposure guideline levels for selected airborne chemicals
Author:
Committee on Acute Exposure Guideline Levels
Year:
2013
Bibliographic source:
Acute exposure guideline levels for selected airborne chemicals, vol 14, The National academic press, Washington, DC, USA, p. 96, ISBN: 978-0-309-28308--3

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Adequate data from a in vivo study (non-LLNA) was already available.

Test material

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

In vivo test system

Test animals

Species:
guinea pig

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Remarks on result:
no indication of skin sensitisation
Remarks:
No skin sensitisation has been reported in exposed workers and no skin sensitisation was noted in a maximization test with n-hexane solution.

Any other information on results incl. tables

Little information was available on skin irritation in humans and laboratory animals after acute exposure to n-hexane vapor. No clinical signs (rubbing, scratching, redness) of skin irritation were reported in acute inhalation studies.

No skin sensitisation has been reported in exposed workers and no skin sensitisation was noted in a maximization test with n-hexane solution. However, operators at a soybean hexane extraction facility had a higher incidence of dry or irritated skin than maintanance workers (65% to 20%). It could not be deducted from WHO (1991) report wether the operators were exposed to n-hexane or solutions of n-hexane.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
n-hexane was not reported to be a skin sensitiser.