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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
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)

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)

Resultsopen allclose all
Reading:
other: overall assessment at challenge
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: other: overall assessment at challenge. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
other: HRIPT overall assessment
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: other: HRIPT overall assessment. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 6.0.

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.