Hexyl acetate

Endpoint summary

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.