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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

Constituent 1
Chemical structure
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.