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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data provided
Route:
other: OET - open and FCAT - intradermal injection
Vehicle:
no data
Concentration / amount:
0.4%
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
Positive control results:
Not reported
Reading:
other: overall assessment at challenge
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
6
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 consistantly negative results are considered to be sufficient to conclude an absence of sensitising potential for hexyl acetate. The results of the two guinea pig assays are also consistent with the results of human testing. Following induction and challenge of 25 male volunteers with hexyl acetate, using a version of the repeat insult patch test, no reactions were apparent in any of the 25 volunteers challenged with hexyl acetate. No evidence of delayed contact hypersensitivity was seen in this human patch test. It is considered unlikely hexyl acetate would elicit contact sensitisation in humans in normal use.

Migrated from Short description of key information:

Complementary testing of n-hexyl acetate in two guinea pig models, one with and one without adjuvant, confirmed the absence of sensitising potential determined in a human repeat insult test.

Justification for selection of skin sensitisation endpoint:

Only one study is available for this endpoint.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The absence of positive sensitisation reactions in animal models and in human patch tests confirmed hexyl acetate does not require classification for delayed contact hypersensitivity according to the CLP Regulation.