Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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