1,2-Propanediol, 3-(hexyloxy)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Jul 2013 - 01 Aug 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(hexyloxy)propane-1,2-diol

EC Number:

600-386-6

Cas Number:

10305-38-1

Molecular formula:

C9H20O3

IUPAC Name:

3-(hexyloxy)propane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): SDX-3255
- Physical state: liquid
- Analytical purity: 99.4%
- Lot/batch No.: 03053
- Expiration date of the lot/batch: May 2014
- Storage condition of test material: room temperature (17.2 to 21.7 °C) in tight, light-resistant containers
- Other: specific gravity: 0.972

Test animals

Species:

rabbit

Strain:

other: NZW (Yac:NZW(KBL)),SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cheonan Yonan College, Laboratory Animal Center, Korea
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.28-2.29 kg
- Housing: stainless wire mesh cages, 450W x 600D x 360H (mm). One animal per cage
- Diet: Purina experimental diet for rabbit 38302AF, ad libitum
- Water: public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum via an automatic watering system
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-21.3
- Humidity (%): 48.0-65.4
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08-07-2013 To: 01-08-2013

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days
Reading time points: 1, 24, 48, 72 h and once daily thereafter for up to 14 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: three sites (2.5x2.5 cm) on the left and right area of the midline was used as the application site.
- % coverage: not stated
- Type of wrap if used: all application sites were covered with gauze (DaeHan Medical Supply Co., Ltd., Korea) and held in contact with the skin by semiocclusive dressing using elastic bandage (3M Co., Ltd., Korea) and paper tape (Masking Tape, DAESUN Com., Korea).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed using absorbent cotten moistened with tepid water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize (1959) scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was evident from day 5 to day 12

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was evident from day 5 to day 14

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was evident from day 5 to day 11

Results 4

Irritation parameter:

edema score

Basis:

other: mean out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Erythema (score 1-2) was evident from 1 hour after patch removal at the test substance sites of all animals. However, skin reactions were no longer evident on day 8 after application. In addition, scaling which was considered to be caused by the secondary changes of stimulation was evident from day 5 up to day 12 in two animals and from day 5 to day 14 in the remaining one animal. The control sites of all animals did not reveal any evidence of adverse skin reactions such as erythema or edema during the observation period.

Other effects:

No abnormal clinical signs or symptoms were evident in any animals throughout the duration of the study. All animals exhibited normal body weight gain. Mean body weight gain was 0.34 kg throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified