Registration Dossier
Registration Dossier
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EC number: 805-622-3 | CAS number: 10305-41-6
Skin irritation / corrosion
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:
- 2 012
- 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
- 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
- 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
Constituent 1
Constituent 2
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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