Orange, sour, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Detailed information on the test substance was not reported. No details on materials & methods and results were reported. Data on materials and methods could be found in the article of Kligman (1966). The results are acceptable as basic data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: JID; Vol 47; No 5; 393-409; 1966

Deviations:

not specified

Principles of method if other than guideline:

A human maximisation test was performed to study the sensitising potential of Orange Oil Bitter. The maximisation procedure consisted of 5 induction exposures and 1 challenge exposure (Kligman, 1966).

GLP compliance:

no

Remarks:

pre-GLP test

Test material

Test material information

Constituent 1

Reference substance name:

Orange Oil Bitter

IUPAC Name:

Orange Oil Bitter

Details on test material:

- Name of test material (as cited in study report): Orange Oil Bitter
- Lot/batch No.: Confidential

Method

Type of population:

general

Controls:

Control patch for the provocative test consisting of petrolatum applied for 48 hours to a site pre-treated for one hour with 10% SLS. No positive controls included.

Route of administration:

dermal

Results and discussion

Results of examinations:

SYMPTOMS
- No data.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0

Any other information on results incl. tables

Reading	Hours after challenge	Group	Dose level	No. with + reactions	Total no. in group	Clinical observations
1st reading	48	test group	undiluted	0	25	no data
2nd reading	72	test group	undiluted	0	25	no data

Applicant's summary and conclusion

Conclusions:

In a human maximization test, Orange Oil Bitter did not induce contact sensitization in any of the 25 healthy adult males under the conditions of this test.

Executive summary:

The sensitising properties of Orange Oil Bitter were investigated in a human maximisation test. Twenthy-five healthy male volunteers completed the experiment. The test material was applied under occlusion to the forearms of all subjects for 5 alternate day 48-hour periods. SLS was used as pre-treatment. Following a 10-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours, also preceeded by 1 hour application of SLS. The challenge sites were read on removal of the patch and 24 hours thereafter. None of the subjects showed sensitisation. Based on these results and according to the EU classification outlined in 1272/2008/EC and 67/548/EEC, the substance Orange Oil Bitter is not a sensitiser.