2-ethylhexane-1,3-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data obtained from a peer-reviewed publication

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1985

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Primary Cutaneuous irritaion study was conducted with a 4 hr occlusive contact time.

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

Details on test material:

- Name of test material (as cited in study report): 2-Ethylhexane-1,3-Diol

- Substance type: Aliphatic Alcohol
- Physical state: Liquid; slightly viscous
- Analytical purity: 98.5

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
3 male and 3 female rabbits
Dorsal skin was clipped prior to exposure.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of undiluted EHD
VEHICLE - None

Duration of treatment / exposure:

Four hours of occluded contact

Observation period:

14 Days

Number of animals:

6 Rabbits

Details on study design:

TEST SITE: - Type of wrap if used: Occlusive dressing
REMOVAL of occlusive dressing: at the end of 4 h. Excess material was removed gently with moist tissue.
The exposure site was inspected for signed of inflammation at 1 h, and 1, 2, 3, and 7 days after removal of the occlusive dressing.
Erythema and edema were scored according to the method of Draize (McCreesh AH and Steinberg M. Skin Irritation Testing in Animals. In: Dermatoxicology and Pharmacology, Marzulli FN and Maibach HI, (Eds.) Hemisphere Publishing Corp. Washington, 1977, p. 196) and the skin was closely examined for other dermal reactions.

Results and discussion

In vivo

Results

Irritation parameter:

other: descriptive

Basis:

mean

Time point:

other: 4 h

Score:

> 0 - < 2

Max. score:

4

Reversibility:

fully reversible within: 24-48 h

Remarks on result:

other: mild irritation, mostly resolved by 24 h.

Irritant / corrosive response data:

At the end of a 4-h occlusive contact period with 0.5 ml of undiluted EHD applied to the clipped dorsal trunk skin, five animals had slight local erythema and one also had well-defined local edema. These effects resolved within 24–48 h

Any other information on results incl. tables

Scores not provided in publication.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After a 4-hour exposure (occluded), undiluted 2-Ethylhexane-1,3-Diol showed mild erythema in five of six rabbits, which resolved in 24-48 h. The substance is considered mildly irritating to rabbits under these conditions.