Tangor, Murcote, 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: Test is performed according to guideline but pre-GLP. Information on substance identity and concentration of test substance is not reported. Report is 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: Maximization Test (JID; Vol. 47; No. 5; 393-409; 1966)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Tangerine oil

IUPAC Name:

Tangerine oil

Details on test material:

- Name of test material (as cited in study report): Tangerine oil
- Lot/batch No.: confidential

Method

Type of population:

general

Controls:

No data

Route of administration:

dermal

Results and discussion

Results of examinations:

SYMPTOMS
- No symptoms observed

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		0	25
2nd reading	72	test group		0	25

Applicant's summary and conclusion

Conclusions:

In a human maximization test with Tangerine oil, no sensitisation was observed in human volunteers under the conditions of this test.

Executive summary:

The sensitising properties of tangerine oil were investigated in a human maximisation test. Twenthy-five healthy male inmate volunteers completed the experiment. For induction, 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. After a 10 -day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours, also preceded 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 Tangerine oil would not classify as a sensitiser.