Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation, other
Remarks:
Maximization test on human volunteers
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs
Year:
1982
Bibliographic source:
Food and Chemical Toxicology. Vol. 20, Pg. 719

Materials and methods

Type of study:
other: Maximization test on human volunteers

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexyl isobutyrate
EC Number:
219-075-8
EC Name:
Hexyl isobutyrate
Cas Number:
2349-07-7
Molecular formula:
C10H20O2
IUPAC Name:
hexyl 2-methylpropanoate
Test material form:
not specified
Specific details on test material used for the study:
Material: RIFM no. 77-221

In vivo test system

Test animals

Species:
other: human

Results and discussion

Any other information on results incl. tables

A maximization test was carried out on 25 volunteers. The material (RIFM no.77 -221) was tested at a concentration of 4% in petrolatum and produced no sensitization reactions. No further information is given.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Hexyl isobutyrate (4% in petrolatum) produced no sensitization reactions in 25 human volunteers.
Executive summary:

Secondary literature data:

A maximization test (1, 2) was carried out on 25 volunteers. The material (RIFM no.77 -221) was tested at a concentration of 4% in petrolatum and produced no sensitization reactions (3).

(1) Kligman, A. M. (1966). The identification of contact allergens by human assay. III. The maximizarion test. A procedure for screening and rating contact sensitizers. J. invest. Derm. 47, 393.

(2) Kligman, A. M. & Epstein, W. (1975). Updating the maximization test for identifying contact allergens. Contact Dermatitis 1, 231.

(3) Kligman, A. M. (1977). Report to RIFM, 15 September.