1-(2-butoxy-1-methylethoxy)propan-2-ol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Proctor and Gamble sponsored study. Acquired via secrecy agreement. The study is acceptable and well documented, which meets basic scientific principles. Basic data given are comparable to guidelines with acceptable restrictions.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeat human patch test method

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-butoxy-1-methylethoxy)propan-2-ol

EC Number:

249-951-5

EC Name:

1-(2-butoxy-1-methylethoxy)propan-2-ol

Cas Number:

29911-28-2

Molecular formula:

C10H22O3

IUPAC Name:

1-(2-butoxy-1-methylethoxy)propan-2-ol

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

82 human volunteers

Route of administration:

dermal

Details on study design:

Route of induction exposure: epicutaneous, occlusive
Route of challenge exposure: epicutaneous, occlusive
Concentration used - 0.4 ml of test substance (unchanged, no vehicle)
Induction: Each individual received an occluded patch containing 0.4 ml of DPnB on Monday, Wednesday and Friday for 24 hours on upper arm. The induction period is 3 weeks.
Challenge: 17 days after the last induction application, duplicate challenge patches were applied for 24 hours.
Scoring of the test sites were conducted after a 24-hour resting period and immediately before the next patch application. Challenge sites were evaluated 48 and 96 hours after application.
Challenge controls: not used
Positive control: not used

Results and discussion

Results of examinations:

The test material showed no evidence of skin sensitization to human volunteers.

Applicant's summary and conclusion

Conclusions:

The test material showed no evidence of skin sensitization to human volunteers.

Executive summary:

A volume of 0.4 ml of DPnB was applied to a Webril disc with a diameter of 24 mm. The Webril disc, providing an occluded
patch was supplied to the upper arm of 82 volunteers nine times over a period of three weeks. During this induction
period each patch was left in place for 24 hours and then removed. Seventeen days after the last induction application, duplicate challenge patches were applied for 24 hours.

The test material showed no evidence of skin sensitization to human volunteers.