2,2-dimethyl-3-phenylpropanol

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable and well documented publication, no single scores were documented, only 20 % pure substance in peanut oil was tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Type of study / information:

Human patch test (skin irritation)

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In an human patch test the test item was tested in a 20 % suspension in vaseline on 50 persons.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-3-phenylpropanol

EC Number:

236-400-9

EC Name:

2,2-dimethyl-3-phenylpropanol

Cas Number:

13351-61-6

Molecular formula:

C11H16O

IUPAC Name:

2,2-dimethyl-3-phenylpropan-1-ol

Method

Ethical approval:

not specified

Details on study design:

STUDY PERIOD: Time of exposition was 24 hours, reaction was examined immediately after removal of the testing patch and 24 hours later.

STUDY POPULATION
- Total number of subjects participating in study: 50 (40 with eczema of various kinds)
- Sex/age/race: 21 women, 29 men

Exposure assessment:

not specified

Details on exposure:

TYPE OF EXPOSURE: Human closed patch test

EXPOSURE PERIOD: 24 hours

Results and discussion

Results:

The preparation was tolerated by all persons without pathological findings. No skin irritation potential was observed.

Applicant's summary and conclusion

Conclusions:

In a human patch test the test item was tested in a 20 % suspension in vaseline on 50 persons. No adverse skin irritation reactions were observed.

Executive summary:

In a human patch test the skin irritation potential of the test item was tested in a 20 % suspension in vaseline on 50 persons. The test area on the body was the shoulder blade. The test was performed by the patch skin test. As testing patch Leukosilk was used. The time of exposure was 24 hours. The reaction to the test was examined immediately after removal of the testing patch and 24 hours later. The interpretation of the test reaction was based on the criteria of the International Contact Dermatitis Research Group. The preparation was tested on 50 persons (21 female, 29 male). 40 persons had eczema of various kinds. Reactions were read at patch removal and again 24 hours after patch removal.Therefore the test was conducted under especially “hard” conditions. No skin irritation reactions were observed.