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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from a 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 study / information:
skin irritation in humans
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Draize, 1944 skin irritation
Principles of method if other than guideline:
Single application patch testing with semi-occlusive or occlusive bandages was undertaken in human volunteers, to assess dermal irritation.
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

Ethical approval:
not specified
Details on study design:
the study involved semi-occlusive and occlusive patch testing of 136 human volunteers.
Exposure assessment:
measured
Details on exposure:
Primary irritation studies were conducted in human volunteers using 5% aqueous and undiluted EHD applied to the skin. Aqueous 5% EHD studies were conducted on 106 subjects (15 men and 91 women, aged 18–80 years). Two applications of solution soaked into 2.0 cm2 blotting paper were made to the infraclavicular skin: one application was covered with an occlusive dressing and the other with a semi-occlusive dressing. Patches were removed after 48 h and the sites evaluated immediately for local irritant effects and again 24 h later. A similar protocol was used for undiluted EHD with 30 subjects (3 men and 27 women, aged 18–80 years).

Results and discussion

Results:
Minor skin irritation was produced in approximately 13% of subjects having sustained cutaneous contact with undiluted EHD. In this group, barely perceptible erythema was observed in two subjects tested with semi-occlusive patches and four subjects with occlusion. Effects were seen at 48 and 72 h. An additional subject demonstrated a definite erythema at 72 h.
Milder reactions were observed using 5% aqueous EHD. Under semi-occlusive conditions only 1/106 subjects showed a barely perceptible erythema on removal of the dressing but not 24 h later. With occlusive conditions, only 1/106 subjects had barely perceptible erythema at 24 and 72 h.

Applicant's summary and conclusion

Conclusions:
Minor primary skin irritation may be produced upon exaggerated exposure of human subjects to 2-ethylhexane-1,3-Diol (EHD), with a greater response seen with undiluted EHD compared with 5% aqueous EHD.