2-ethylhexane-1,3-diol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from published study in a peer-reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Toxicology Update 2-Ethyl-1,3-hexanediol

Author:

Ballantyne B

Year:

2005

Bibliographic source:

J. Appl. Toxicol 25: 248-259

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize 1944 human patch testing

Principles of method if other than guideline:

Human volunteers received repeated applications of undiluted substance under occlusive patches for 3 weeks and dermal sensitisation (erythema and edema) was assessed.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexane-1,3-diol

EC Number:

202-377-9

EC Name:

2-ethylhexane-1,3-diol

Cas Number:

94-96-2

Molecular formula:

C8H18O2

IUPAC Name:

2-ethylhexane-1,3-diol

Test material form:

liquid: viscous

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

203 male (n=31)and female (n=172) human volunteers

Controls:

Erythema and edema was compared with previous studies on the skin irritation potential of EHD.

Route of administration:

dermal

Details on study design:

During induction, single occlusive applications of 0.2 ml of EHD were made to the infrascapular skin three times a week for three consecutive weeks. Patches were left in contact for 24 h and then removed; the site was evaluated for local inflammatory reactions after a further 24 h. A rest period of 2 weeks followed the 3-week induction period. Then an occlusive challenge patch was applied for 24 h to an uncontaminated skin site. Challenge sites were evaluated 24 and 48 h after removal of the challenge patches.

Results and discussion

Results of examinations:

The incidence of marginal and definite erythematous responses was similar to that seen in previous skin irritation tests in human subjects (where mild skin irritation was observed). Twenty-one of 202 subjects showed a barely perceptible erythema and 2/202 subjects converted to a definite erythema during the induction phase. Two subjects showed a definite erythema 48 h after removal of the challenge patches. They were retested using occlusive and semi-occlusive patches applied to the skin of the flexor aspect of the arm. One subject demonstrated a definite erythema and edema under occlusive conditions, but the other subject showed only a questionable response. Thus there was clear evidence for a skin sensitizing response with only 1/203 subjects (0.5%), indicating that EHD is a weak skin sensitizer.

Any other information on results incl. tables

The skin reactions were compared to skin reactions in a 21-day cumulative occluded skin irritation test in humans.

Applicant's summary and conclusion

Conclusions:

2-Ethylhexane-1,3-Diol is a weak human sensitiser, as one of 202 subjects who participated in a human Draize sensitization assay developed a definitive response. Mild dermal irritation was observed in two-four other participants.