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EC number: 805-622-3 | CAS number: 10305-41-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- preliminary study: 9-12 Aug 2010; main study: 18 Aug - 11 Sep 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 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- only 5 animals was used in the treatment groups
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- an in vitro skin sensitization study does not need to be conducted because adequate data from an in vivo skin sensitization study is available.
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
- Other: flash point: 159 °C
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Slc:Hartley, SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc., Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 340-387 g
- Housing: stainless wire mesh cages, 210W x 350D x 180H (mm). 1 animal per cage during the study.
- Diet: Purina experimental diet for guinea pigs 38065. The diet was placed in feeders and provided ad libitum
- Water: public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum via a polycarbonate bottle (500 mL) in an quarantine room and by an automatic watering system in the animal room
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3-21.5
- Humidity (%): 46.6-71.8
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- First induction: 12%
Second induction: 100%
Challenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- First induction: 12%
Second induction: 100%
Challenge: 25%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Two guinea pigs were injected intradermally with 0.1 mL (midline of the shaved shoulder region) of the test substance at dose levels of 100, 50, 25, 12.5, 6.25 and 3.13% w/v (six sites, three of each on the left and right side of the midline of the shaved shoulder region). In addition, for topical applications, 0.1 mL of test substance concentration (100, 50, 25, 12.5, 6.25 and 3.13% w/v) was applied to two further animals. Animals were wrapped with occlusive dressing for 24 hours. The skin reactions were then evaluated at 24 and 48 hours after intradermal injection and 24 and 48 hours after patch removal according to the evaluation standard of skin reaction by Magnusson and Kligman. The following doses were chosen for the main study based on the results of this preliminary study: The dose level for the first induction was selected as 12% as this is approximate to 12.5% which was tested, and which was the highest concentration that did not produce necrosis at the intradermal injection sites. The dose level for the second induction was selected at 100%, as it was the highest concentration that produced slight to moderate skin reactions at the topical application sites. For the challenge induction, the dose level was selected at 25%, as no any skin reactions at the topical application sites were observed at this concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal ( 3 pairs of 0.1 mL injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 12% (w/v) test substance in water
Injection 3: 12% (w/v) test substance in FCA
Epicutaneous: 0.2 mL of 100% test substance
- Control group:
Intradermal ( 3 pairs of 0.1 mL injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: water
Injection 3: a 1:1 mixture (v/v) FCA/water
- Site: shoulder region
- Frequency of applications: every 7 days
- Duration: 0-8 days
- Concentrations: 12% interdermal and 100% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Test and control groups: 0.1 mL of the 25% test substance
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (CDNB)
Results and discussion
- Positive control results:
- The positive control substance (0.1% CDNB in olive oil) induced positive reactions in 5/5 animals (100%) at 24 and 48 hours after challenge patch removal. On the other hand, the sensitisation rates for the olive oil challenge sites were determined to be 0% at 24 and 48 hours after challenge patch removal.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction intradermal: 12%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Induction intradermal: 12%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction intradermal: 12%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction intradermal: 12%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction intradermal: 0.1%; challenge: 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Induction intradermal: 0.1%; challenge: 0.1%. No with. + reactions: 5.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction intradermal: 12%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction intradermal: 12%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction intradermal: 12%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction intradermal: 12%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction intradermal: 0.1%; challenge: 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Induction intradermal: 0.1%; challenge: 0.1%. No with. + reactions: 5.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Table 2: Mean skin reaction scores
Test group |
Substance for sensitisation |
Substance for challenge |
Score of skin reactiona |
No. of animals |
No. of animals with positive reactions |
Sensitisation rate (%) |
||
1stconcentration |
2ndconcentration |
24 hoursb |
48 hoursb |
|||||
G1 Test substance |
SDX-3012 (12%) |
SDX-3012 (100%) |
SDX-3012 (25%) |
0 |
5 |
5 |
0/5 |
0 |
1 |
0 |
0 |
||||||
2 |
0 |
0 |
||||||
3 |
0 |
0 |
||||||
Mean score |
0.0 |
0.0 |
||||||
Water |
0 |
5 |
5 |
0/5 |
0 |
|||
1 |
0 |
0 |
||||||
2 |
0 |
0 |
||||||
3 |
0 |
0 |
||||||
Mean score |
0.0 |
0.0 |
||||||
G2 Control |
Water |
Water |
SDX-3012 (25%) |
0 |
5 |
5 |
0/5 |
0 |
1 |
0 |
0 |
||||||
2 |
0 |
0 |
||||||
3 |
0 |
0 |
||||||
Mean score |
0.0 |
0.0 |
||||||
Water |
0 |
5 |
5 |
0/5 |
0 |
|||
1 |
0 |
0 |
||||||
2 |
0 |
0 |
||||||
3 |
0 |
0 |
||||||
Mean score |
0.0 |
0.0 |
||||||
G3 Positive control |
CDNB (0.1%) |
CDNB (0.1%) |
CDNB (0.1%) |
0 |
0 |
0 |
5/5 |
100 |
1 |
0 |
0 |
||||||
2 |
0 |
0 |
||||||
3 |
5 |
5 |
||||||
Mean score |
0.0 |
0.0 |
||||||
Olive oil |
0 |
5 |
5 |
0/5 |
0 |
|||
1 |
0 |
0 |
||||||
2 |
0 |
0 |
||||||
3 |
0 |
0 |
||||||
Mean score |
0.0 |
0.0 |
||||||
aMagnusson & Kligman grading scale
bObservation after patch removal for challenge
CDNB : 1-Chloro-2,4-dinitrobenzene
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 were 133 g, 129 g and 134 g in the test substance, negative control and positive control groups, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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