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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Aug 2010 - 20 Aug 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
occluded dressing, 24 h treatment, abraded sites included and dilution of liquid test substance
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(cyclohexyloxy)propane-1,2-diol
EC Number:
805-622-3
Cas Number:
10305-41-6
Molecular formula:
C9H18O3
IUPAC Name:
3-(cyclohexyloxy)propane-1,2-diol
Constituent 2
Reference substance name:
3-cyclohexyloxy-1,2-propanediol
IUPAC Name:
3-cyclohexyloxy-1,2-propanediol
Details on test material:
- Name of test material (as cited in study report): SDX-3012
- Physical state: liquid
- Analytical purity: > 99%
- Lot/batch No.: 019X9
- Expiration date of the lot/batch: Oct.2010
- Storage condition of test material: room temperature (20.6-21.2 °C), nitrogen substitution

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: 16 weeks
- Weight at study initiation: 2.38-2.49 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): 18.0 - 21.6
- Humidity (%): 47.4 - 69.6
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2010-08-09 To: 2010-08-20

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded sites
Vehicle:
water
Controls:
other: sites treated with water of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 10 and 50%

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat
- Lot/batch no.: GBA0001
Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: six sites (2.5x2.5 cm) below the suprascapular area, on each side of the midline. Three areas were assigned to the intact sites and the others served as the abraded sites.
- % coverage: not stated
- Type of wrap if used: all application sites were covered with a gauze patch (3M Tegaderm Transparent Dressing, Orginal Frame Style, 3M Co., Ltd., U.S.A.) and dressed with Lint cloth plaster (Soft Cloth Tape With Liner, width 10 cm, 3M Co., Ltd., Korea). Both sides were fixed with paper masking tape (DAESUN Com., Korea) and held in contact with the skin by an occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed using absorbent cotten moistened with tepid water
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize (1959) scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema 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: not applicable
Remarks on result:
other: 10% test substance on intact sites
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: not applicable
Remarks on result:
other: 10% test substance on intact sites
Irritation parameter:
erythema score
Basis:
animal: mean out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 50% test substance on intact sites
Irritation parameter:
edema score
Basis:
animal: mean out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 50% test substance on intact sites
Irritant / corrosive response data:
On the 10% test substance sites, no skin reactions were evident on abraded sites at 24, 48 and 72 hours after application. On the 50% test substance sites, erythema (score 1) was evident on abraded sites at 24 and 48 hours after application. The erythema (score 1) seen was then fully reversed within 72 hours after application on the abraded sites. On the control sites, no skin reactions were seen on abraded sites at 24, 48 and 72 hours after application.
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 gains. Mean body weight gains was 0.06 kg.

Any other information on results incl. tables

Table 1: Individual skin irritation scores

 

Animals ID

Erythema/edema scores

Intervals (hours)

24

48

72

Intact skin

Intact skin

Intact skin

10% Test substance

1101

0/0

0/0

0/0

1102

0/0

0/0

0/0

1103

0/0

0/0

0/0

Mean over 24, 48 and 72 h

0

50% Test substance

1101

1/0

1/0

0/0

1102

1/0

1/0

0/0

1103

1/0

1/0

0/0

Mean over 24, 48 and 72 h

0.7

Water

1101

0/0

0/0

0/0

1102

0/0

0/0

0/0

1103

0/0

0/0

0/0

Mean over 24, 48 and 72 h

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating at a concentration of 10 and 50%
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified for 10% and 50% test substance concentration
DSD: not classified for 10% and 50% test substance concentration

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