2,5-dimethylhexane-2,5-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: well-documented, guideline-conform, but non-GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,5-dimethylhexane-2,5-diol

EC Number:

203-731-5

EC Name:

2,5-dimethylhexane-2,5-diol

Cas Number:

110-03-2

Molecular formula:

C8H18O2

IUPAC Name:

2,5-dimethylhexane-2,5-diol

Details on test material:

Name of the test substance used in the study report: 2,5-Dimethylhexandiol-2,5
Analytical purity: 99.5%
Lot/batch No.: 21922-108
Stability under test conditions: yes

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

One animal per cage (stainless steel with mire mesh walk floors (40 x 51 cm), no bedding).
The rabbits were identified via ear tattoo.
They were housed in fully air-conditioned rooms with a temperature ranging between 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
The animals were offered a standardized animal laboratory diet (ca. 130 g/animal/day) as well as about 250 ml tap water/animal/day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping of the fur

Vehicle:

unchanged (no vehicle)

Remarks:

unchanged, moistened with water

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

The test patch (2.5 cm x 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and had been moistened with aqua dest.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: porous dressing ( four layers of absorbent gauze + porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure periode

SCORING SYSTEM:
erythema/edema: according to OECD Guideline 404 (only the readings of 24, 48 and 72 hrs were used)

Clipping of the fur: at least 15 h before the beginning of the study; readings: 30-60 min after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Only on one male animal erythema formation occurred (4-h reading; erythema score 1), but it was fully reversible within 20 hrs (at the 24 hrs reading). No edema was detected.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the available data, the test substance showed no irritating potential after application to the skin of rabbits.

Executive summary:

The undiluted test substance was droped at a test patch (2.5 x 2.5 cm). After adsorption the patch was placed on the upper third of the back or flanks. The untreated skin sites served as the negative control. The reading of the parameter was conducted 24, 48, and 72 hours after removal of the test patches. Based on the results of the available data, the test substance showed no irritating effects after application to the skin of rabbits.