Butane-1,3-diol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was well performed with sufficient participants, but the purity of the test substance was not stated.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeated Insult Patch test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,3-diol

EC Number:

203-529-7

EC Name:

Butane-1,3-diol

Cas Number:

107-88-0

Molecular formula:

C4H10O2

IUPAC Name:

butane-1,3-diol

Test material form:

liquid

Details on test material:

Name of test material (as cited in study report): 1,3 butylene glycol; 50% aqueous solution, provided by Celanese Chemical Company

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 200
- Sex: 120 females, 80 males
- Age: 6-67 years
- Race: not stated

Clinical history:

Individuals of general well-being, absence of any skin diseases "which might be confused with skin reactions from the test material"

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Repeated Insult Patch Test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: lintine pad
- Vehicle / solvent: water
- Concentrations: 50% aqueous solution
- Volume applied: 0.9 ml

A. INDUCTION EXPOSURE
- No. of exposures: 15
- Exposure period: 24 h
- Test groups: 80 males/120 females
- Control group: none
- Site: upper arm
- Frequency of applications: Monday, Wednesday, Friday
- Duration: 5 weeks
- Concentrations: 50% aqueous solution

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after induction has been finished
- Exposure period: 24 h
- Test groups: 80 males/120 females
- Control group: none
- Site: upper arm (same site as induction site)
- Concentrations: 50% aqueous solution
- Evaluation (h after challenge): 0, 24, 48 h

EXAMINATIONS
- Grading/Scoring system: 0 (no reactions), 1+ (slight erythema), 2+ (marked erythema), 3+ (marked erythema, edema, with or without a few vesicles), 4+ ( marked erythema, edema, with vesicles and oozing)
- Statistical analysis: Statistical analysis was performed, but not stated in detail.

Results and discussion

Results of examinations:

No signs of sensitisation were oberserved. Transient mild skin irritation was reported in 2 out of the 200 subjects (grade 2+ at exposure no. 5 and grade 3+ at exposure no. 14, respectively). After changing the site of application no further signs of irritation were observed with these indviduals.

The author claimed that based on these results and the power of the study at least 98.17% of the general population will not be sensitised (95% certainty).

Applicant's summary and conclusion

Conclusions:

Under these experimental conditions, a 50% aqueous solution of the test substance produced no skin sensitisation.

Executive summary:

200 subjects (80 males, 120 females) were induced with 50% aqueous solution (0.9 ml) of the test substance for 15 times (24 h each) within 5 weeks (exposures on Monday, Wednesday and Friday) by occlusive patch exposures at the upper arm. Two weeks later they were challenged with a 24 h occlusive patch exposure at the same site. A transient mild skin irritation was reported in 2 subjects, but no sensitisation was observed (Shelanski 1973, 1974).