3-(2,2-dimethyl-3-hydroxypropyl)toluene

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

publication

Title:

Fragrance contact dermatitis – a worldwide multicenter investigation (Part III)

Author:

Larsen, W. et al.

Year:

2002

Bibliographic source:

Contact Dermatitis, 46, 141-144

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Patch test methods and readings were conducted according to internationally accepted criteria (Fischer & Maibach, 1984; Nethercott, 1991) and involved the Finn Chamber patch test technique.

- Short description of test conditions: 218 fragrance-sensitive volunteers were evaluated for skin reactions after exposure to the test substance for 2-3 days. Additional readings were done 2 - 5 days after first reading.
- Parameters analysed / observed: skin reaction after application of the test substance

Fischer T., Maibach H. I. (1984) Finn Chamber patch test technique. Contact Derm 1984: 11: 137–140.
Nethercott J. R. et al. (1991) Patch testing with a routine screening tray in North America 1985–1989. I. Frequency of response. Am J Contact Dermatitis 1991: 2: 122–129.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(2,2-dimethyl-3-hydroxypropyl)toluene

EC Number:

403-140-4

EC Name:

3-(2,2-dimethyl-3-hydroxypropyl)toluene

Cas Number:

103694-68-4

Molecular formula:

C12H18O

IUPAC Name:

2,2-dimethyl-3-(3-methylphenyl)propan-1-ol

Method

Type of population:

other: patients with proven contact dermatitis due to fragrance materials

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 217
- Sex: 85.3% females and 14.3% males
- Age: 46.3 ± 14.7
- Demographic information: Volunteers were tested in Japan, Northern Ireland, United States, England, Germany, Switzerland and Sweden. The majority of the subjects were Caucasian.

Clinical history:

- History of allergy or casuistics for study subject or populations: All patients had proven contact dermatitis due to fragrance materials. Facial eruptions (28.0%) and hand (26.1%) and neck (10.6%) involvement were the most common location for eczematous dermatitis. Alll patients were free of eczema.
- Exposure history: Volunteers had proven sensitization to at least one fragrance material established by previous patch tests to fragrance allergens.
- Any other allergic or airway disorders: Many patients reported a personal history of hay fever, asthma or atopic dermatitis.

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: not specified
- Description of patch: Finn patch
- Concentrations: undiluted
- Testing/scoring schedule: The patch test sites were evaluated initially at 2 - 3 days. The sites were reexamined in the majority of cases, usually between 2 and 5 days after the 1st reading.

EXAMINATIONS
- Grading/Scoring system: not specified

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: 3.2% positive response in 217 patients

Applicant's summary and conclusion

Conclusions:

In this human patch test in patients with proven contact dermatitis due to fragrance materials, the undiluted test substance induced sensitisation in 3.2% of 217 patients. Therefore, the test substance is regarded as skin sensitising.