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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

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1985
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

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
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.