Octane-1,2-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: see 'Remark'

Remarks:

Well documented and reported study fully adequate for assessment. The study was conducted according to an internationally accepted technical guideline and in compliance with GLP in a recognized contract research organization. The present robust study summary is based only on a translation of the original study report, but both were written by the study director himself.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guide to Quasi-drug and Cosmetic Regulations in Japan, Yakuji Nippo, Ltd., Feb. 2006

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octane-1,2-diol

EC Number:

214-254-7

EC Name:

Octane-1,2-diol

Cas Number:

1117-86-8

Molecular formula:

C8H18O2

IUPAC Name:

octane-1,2-diol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species, Strain: Rabbit, NZW (Yac:NZW(KBL))
- Source: Yonam College of Agriculture
San 3-1, Suhyang-ri, Seonghwan-eup, Cheonan-si,
Chungcheongnam-do, Korea
- Number and Sex: 3 males were dosed in the study (selected from 5 males with suitable skin sites)
- Age at start of dosing (Day 1): 16 weeks
- Weight prior to dosing (Day 1): Minimum 2.71 kg, maximum 2.92 kg
- Housing: Individual housing in stainless steel cages (38 x 49 x 35 cm) with automated flush system
- Diet (ad libitum): Purina experimental diet for rabbits 5302 from Agribrands Purina Korea Inc.
- Water(ad libitum) : Filtered and purified public tap water (municipal supply), supplied in polycarbonate bottles
- Acclimation period: Ca. 2.5 months prior to study start under laboratory conditions.

Routine analysis of the diet used for nutrients and possible contaminants and of the drinking water for specified microorganisms and environmental contaminants were conducted or available at the testing facility. There were no known contaminants in the diet or water at levels that would be expected to interfere with or affect the results of the study.

ENVIRONMENTAL CONDITIONS IN THE ANIMAL ROOM

- Temperature (°C): 21.6 to 23.6°C
- Relative Humidity (%): 40.2 to 61.6%
- Photoperiod: 12 hours light, 12 hours dark per 24 hours
- Intensity of ilumination: 150 to 300 Lux
- Rate of air exchange: 10 to 15 changes/h (all fresh air)

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

The neat test material was warmed to 40-50°C for 10 minutes for liquefaction and then kept at room temperature for 10 minutes until use for dosing

Controls:

not required

Amount / concentration applied:

0.5 mL undiluted pre-warmed liquid test material per approx. 6 cm2 intact or abraded, clipped skin

Duration of treatment / exposure:

24 hours

Observation period:

72 hours post exposure start (i.e. the final observation time point was 48 hours post patch removal)

Number of animals:

3 males

Details on study design:

TEST SITE PREPARATION AND ADMINISTRATION
On the day before treatment, hair was removed with clippers from the dorsal region (left and right side of the spine) of each animal. Samples of 0.5 mL of the liquefied, neat test material were applied to the clipped intact and to clipped and then abraded skin of albino rabbits by means of gauze patches each of approx. 6cm2 size (2.5cm x 2.5 cm each; 0.5 mL test material per gauze patch). Prior to use the neat test substance was liquefied by warming for approx. 10 minutes to 40-50°C and then left for 10 minutes at room temperature before being administered to the gauze patches. Patches were fixed with commercially available transparent sticking plaster, then with Lint cloth plaster and finally with paper masking tape and held in contact with the intact or abraded skin sites by occlusive dressing.

On each animal one additional clipped intact skin site and one clipped and then abraded site remained untreated but were covered and dressed occlusively in the same manner as the treated skin sites and acted as a controls.

REMOVAL OF TEST MATERIAL
At the end of the 24 hour exposure period, the occlusive dressing and gauze patches and residual test material were removed, the latter by use of absorbent cotton moistened with tepid water.

TIME POINTS OF SKIN EVALUATION:
The treated skin patches were evaluated 24, 48 and 72 h after exposure start, (i.e. immediately, 24 & 48 hours post patch removal). The study was terminated after the final reading (72 h after exposure start), as on all occasions all animals were entirely free from skin reactions (erythema or edema). The scoring system for the grading of skin reactions is listed in Table 1 (next field below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Administered to intact skin for 24 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: administered to intact skin for 24 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: administered to intact skin for 24 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Administered to intact skin for 24 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: administered to intact skin for 24 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: administered to intact skin for 24 h

Irritant / corrosive response data:

In each animal, clipped intact and clipped abraded skin patches treated with liquefied neat test material for 24 hours were free from erythema, scab or edema formation at any observation time point of the study, i.e. at 24, 48 and 72 hours after treatment start.

Other effects:

Mortality or clinical signs attributable to treatment with the test material were not evident and bodyweight development was normal in all animals.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Occlusive administration of 1,2-octanediol to clipped, intact or clipped, abraded skin of three rabbits for 24 hours did not induce any skin reactions during the present study, i.e. during 72 hours after treatment start. According to EU classification rules [REGULATION (EC) 1272/2008] the outcome of this study does not necessitate any labelling regarding skin irritation.