Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
0
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.