Orange, sweet, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

12 May 2003 - 26 August 2003

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: This study was not conducted according to an OECD guideline or under GLP conditions, as it is a human study. No infomration is available on test concentration or vehicle, therefore the study was assigned Klimish 3.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Marzulli-Maibach sensitization technique

Principles of method if other than guideline:

100 male or female volunteers (18-64 years) were exposed to the test article on the back during the induction phase 3 times/week for 48 hours for 3 weeks. Following a two week resting period, the subjects were challenged by application of test article for 24 hours on the induction and a control site. Skin reactions were scored immediately and 24, 48 and 72 hours after removal of the patches.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Orange, sweet, ext.

EC Number:

232-433-8

EC Name:

Orange, sweet, ext.

Cas Number:

8028-48-6

Molecular formula:

This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.

IUPAC Name:

Essential oil of orange obtained from the peel of Citrus sinensis (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities

Constituent 2

Reference substance name:

Orange oil

IUPAC Name:

Orange oil

Constituent 3

Reference substance name:

Huille essentielle d'orange douce de floride

IUPAC Name:

Huille essentielle d'orange douce de floride

Details on test material:

- Name of test material (as cited in study report): Huile essentielle d'orange douce de floride (Orange oil)

Method

Type of population:

general

Controls:

Patches without test article applied were used as control group

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: open
- Vehicle / solvent: No data
- Concentrations: No data
- Volume applied: 30 µl
- Testing/scoring schedule: Skin reactions were scored immediately and 24, 48 and 72 hours after removal of the patches

EXAMINATIONS
- Grading/Scoring system: Erythema and desquamation scores were used to determine irritation index Z
- Statistical analysis: No data

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: 4% of the subjects showed a positive skin reaction at the first reading (24 hours) after challenge. No reaction was noted in the test group at the 48 and 72 hours reading and at any timepoint in the control group. Based on these results the substance was not considered to be sensitising.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
24 hours reading
- Number of subjects with positive reactions: 4
- Number of subjects with negative reactions: 96
- Number of subjects with equivocal reactions: 0

48 hours reading
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 100
- Number of subjects with equivocal reactions: 0

72 hours reading
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 100
- Number of subjects with equivocal reactions: 0

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, 4% of the subjects showed a positive skin reaction at the first reading (24 hours) after challenge. No reaction was noted in the test group at the 48 and 72 hours reading and at any timepoint in the control group. Based on these results the substance was not considered to be sensitising.

Executive summary:

100 male or female volunteers (18-64 years) were exposed to the test article on the back during the induction phase 3 times/week for 48 hours for 3 weeks. Following a two week resting period, the subjects were challenged by application of test article for 24 hours on the induction and a control site. Skin reactions were scored immediately and 24, 48 and 72 hours after removal of the patches.

 

Under the conditions of this study, 4% of the subjects showed a positive skin reaction at the first reading (24 hours) after challenge. No reaction was noted in the test group at the 48 and 72 hours reading and at any timepoint in the control group. Based on these results the substance was not considered to be sensitising.