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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: handbook
Adequacy of study:
key study
Study period:
Published in 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The comparative assessment of two sensitisation methods includes limited results for hexyl acetate but is sufficient to support a conclusion that the substance is not a skin sensitiser.

Data source

Reference
Reference Type:
review article or handbook
Title:
The Freund's Complete Adjuvant Test and the Open Epicutaneous Test A Complementary Test Procedure for Realistic Assessment of Allergenic Potential
Author:
G. Klecak
Year:
1985
Bibliographic source:
Curr. Probl. Derm., vol.14, pp.152-171

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Comparative assessment of skin sensitising potential in an adjuvant method (Freund’s Complete Adjuvant Test FCAT) and a non-adjuvant method (Open Epicutaneous Test).
GLP compliance:
no
Type of study:
other: Comparison of open epicutaneous test and Freund’s Complete Adjuvant Test (FCAT)
Justification for non-LLNA method:
study was done before LLNA method was first choice

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexyl acetate
EC Number:
205-572-7
EC Name:
Hexyl acetate
Cas Number:
142-92-7
Molecular formula:
C8H16O2
IUPAC Name:
hexyl acetate
Constituent 2
Reference substance name:
acetic acid hexyl ester
IUPAC Name:
acetic acid hexyl ester
Test material form:
not specified
Details on test material:
No details provided

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data provided

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: OET - open and FCAT - intradermal injection
Vehicle:
no data
Concentration / amount:
0.4%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
0.4%
No. of animals per dose:
No details available
Details on study design:
refer to "any other information on materials and methods" field below
Challenge controls:
No details
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not reported

In vivo (non-LLNA)

Results
Reading:
other: overall assessment at challenge
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
6

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Complementary testing of n-hexyl actate in two guinea pig models, one with and one without adjuvant, indicate the absence of sensitising potential.
Executive summary:

No evidence of skin sensitisation was seen with hexyl acetate, either in the Freund's Complete Adjuvant Test (FCAT: an adjuvant method) or in the Open Epicutaneous Test (OET: a non-adjuvant method). Although the studies are of non-standard design, the constently negative results are considered to be sufficient to conclude an absence of sensitising potential for hexyl acetate.