3-methoxybutyl acetate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1973

Justification for type of information:

Human Repeat Insult Patch Study to demonstrate no potential for skin sensitisation.

Materials and methods

Method

Type of population:

general

Subjects:

200 Human Subjects: 80 Males, 120 Females

Route of administration:

dermal

Details on study design:

group of 200 individuals who qualified were selected from a local population. The criteria for selecting these individuals were:
1. General well-being.
2. Absence of any skin diseases which might be confused with skin reactions
from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract.
(In the case of minors, parental consent was obtained.)
Sites on the upper arm of each individual were designated for contact with the test material. A total of sixteen applications, each of twenty-four hours'
duration, were scheduled to be carried out .

Results and discussion

Results of examinations:

The observations of each individual on a daily basis are appended.
1. Skin Changes Accompanying Application No.1:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
2. Skin Changes Accompanying Application Nos. 2 through 15:
Visible skin changes signifying reaction to injury were observed in 2 of the 200 subjects (Subject No. 31, Age 15, and Subject No. 34, Age 43).
3. Skin Changes Accompanying Challenge Application:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.

Applicant's summary and conclusion

Conclusions:

Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test
subjects. In this case, since 200 subjeets were used, we may predict with 95% certainty that at least 98.17% of a general population will not
be sensitized by this material.

Executive summary:

Under completely occluded conditions, Celanese Chemical Company - 50-50 Blend in Wat.er of 1, 3 Butylene Glycol, was capable of eliciting

visible skin changes consistent with the criteria deemed characteristic of a mild fatiguing agent in 2 out of 200 subjects.

In the opinion of the investigator, Celanese Chemical Company - 50-50 Blend in Water of 1, 3 Butylene Glycol may be considered safe to use in contact with the skin insofar as primary irritation or sensitization are concerned if the conditions of contact do not exceed those of the test procedure.

Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test

subjects. In this case, since 200 subjeets were used, we may predict with 95% certainty that at least 98.17% of a general population will not

be sensitized by this material.