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EC number: 700-043-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Date of study initiation: September 8, 2006, Date of study completion: November 30, 2006 8.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Available guinea pig study report from 2006. Additional LLNA study scientifically not necessary.
Test material
- Reference substance name:
- (2R)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2R)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate; (2S)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2S)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate
- EC Number:
- 700-043-1
- Molecular formula:
- C24H56O8Si5
- IUPAC Name:
- (2R)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2R)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate; (2S)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2S)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Compound A
-Lot numbeer: T060620
- Appearance: clear to mild yellowish transparent liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Std: Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Inc
- Age at study initiation: 6 weeks
- Weight at study initiation: 384.7 – 451.8g
- Housing: Guinea pig rack - Size D×W×H = 450 × 1600 × 1970 (mm), Cage accommodation = 5 cages per shelf, 4 shelves, 20 cages/rack, Material = Stainless. Guinea pig cage (Cage G) - Size D×W×H = 355 × 225 × 245 (mm) Floor space: 798 cm2, Material – Aluminum.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Measured value 22.4-23.2°C
- Humidity (%): Measured value 48.2 - 59.0%
- Air changes (per hr): >7
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- 25, 50 and 100% v/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 25, 50 and 100% v/v
- No. of animals per dose:
- 10 per test solution dose
- Details on study design:
- RANGE FINDING TESTS: In order to confirm the maximum concentration at which no irritation is observed under the conditions of provocation by skin application, the preliminary study was conducted. Concnetrations of test substance applied = 100%, 50% and 25%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 48 hour for epicutaneous
- Test groups: Distilled water/FCA (Freunds Complete Adjuvant); original test solution; original test solution/FCA containing 50% test solution)
- Control group:
Negative controls- Distilled water
Positive control - DNCB (1-Chloro-2,4-dinitrobenzene)
- Site: dorsal cervix
- Frequency of applications: single
- Duration: 14 days until challenge exposure
- Concentrations: As described and in table below :'Constitution of dose groups'
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: Provocation by skin application was conducted 14 days afer sensitization by skin application.
- Exposure period: 24 hours
- Test groups: Test solution, test solution in acetone, acetone
- Control group:
negative; distilled water
postive; DNCB in Acetone
- Site: abdomen
- Concentrations: As described in table below: 'Constitution of dose groups'
- Evaluation (hr after challenge): 24, 48 and 72 hours
- Challenge controls:
- Negative and positive controls used for provocation by skin application.
- Positive control substance(s):
- yes
- Remarks:
- Known sensitizer used (DNCB)
Results and discussion
- Positive control results:
- For the 5 cases with the solvents, no erythema, incrustation, or edema were found in terms of the skin surfaces at 24 hours, 48 hours, and 72 hours after the sensitizations.
The mean score and reaction rate were 0 points and 0%, respectively. In the post 24-hour study for the positive control substances, erythema and incrustation (very mild edema, 2/5 cases; clearly visible erythema, 2/5 cases; moderate or severe erythema, 1/5 case), and edema (no edema, 2/5 cases; very mild edema, 3/5 cases) were observed; the corresponding mean score and reaction rate were 2.4 points and 100%, respectively.
In the post 48-hour study, erythema and incrustation (very mild edema, 3/5 cases; clearly visible erythema, 1/5 case; moderate or severe erythema, 1/5 case), and edema (no edema, 1/5 case; very mild edema, 3/5 cases; mild edema, 1/5 case) were observed; the corresponding mean score and reaction rate were 2.6 points and 100%, respectively.
In addition, in the post 72-hour study, erythema and incrustation (very mild edema, 1/5 case; clearly visible erythema, 4/5 cases), and edema (no edema, 1/5 case; very mild edema, 2/5 cases; mild edema, 2/5 cases) were observed; the corresponding mean score and reaction rate were 3.0 points and 100%, respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test solution
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- very mild erythema was observed in one case, clearly visible erythema was observed in one case
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test solution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- very mild erythema observed in one case
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100% test solution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Very mild erythema observed in one case
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Yes
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Yes
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Yes
Any other information on results incl. tables
Test Solution Group
For the 10 cases with the solvents and test solutions (50% and 25%), no erythema, incrustation, or edema were found in terms of the skin surfaces at 24 hours, 48 hours, and 72 hours after the sensitizations. The mean score and reaction rate were 0 points and 0%, respectively. However, at 24 hours after the sensitization in the 100% test solution study, erythema and incrustation (very mild erythema, 1/10 case; clearly visible erythema, 1/10 case) were observed, and mean the score and reaction rate were 0.3 points and 20%, respectively. At 48 hours and 72 hours after the sensitizations, erythema and incrustation (very mild erythema, 1/10 case) were observed, and the mean score and reaction rate were 0.1 points and 10%, respectively.
In the test solution groups, a weak positive skin reaction was found at the provoking concentration of 100% whereas no positive skin reactions were found at the provoking concentrations of 25% and 50% throughout the entire study period.
Accordingly, a potential to induce delayed-type hypersensitivity (sensitization) of the test substance under the conditions in this study was found at the provoking concentration of 100% as a weak positive case, suggesting the result to suspect sensitization. However, it was negative at the provoking concentrations of 25% and 50%, and it should not present any problem as the extent of the observed effect was very weak as compared to that in the positive control substances.
Please see attached Table 2. Skin Reactions After the Provocations in the In Vivo Skin Sensitization Study of Compound A Using Guinea Pigs for results for each group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A skin sensitization study using guinea pigs was conducted employing the maximization method to determine the presence/absence of skin sensitization for the test substance. As a result, a weak positive skin reaction was observed at a provoking concentration of 100%, but no positive reactions were observed at provoking concentrations of 25% and 50% throughout the entire observation period.
Accordingly, with regard to the potential to induce delayed-type hypersensitivity (sensitization) of the test substance under the experimental conditions of this study, a weak positive case was found at a provoking concentration of 100%, indicating the result at which to suspect sensitization. However, the sensitization was negative at provoking concentrations of 25% and 50% with very weak strengths as compared to those of the positive control substances; therefore, there should be no problems. - Executive summary:
The purpose of the study was to determine if the test substance had the potential to induce delayed-type hypersensitivity (skin sensitization) in guinea pigs.
The maximization method was followed to conduct the skin sensitization test using guinea pigs in order to determine the absence/presence of skin sensitization.
In the preliminary study for dose finding, since no skin reactions were observed after the maximum dose of 100% was applied to the skin, it became clear that there should be no irritation with the test substance or the effect should be extremely weak.
As a result of the observations on the skin conditions in all the groups at 24 hours, 48 hours, and 72 hours after the provocation by skin application, no skin reactions were found in all the animals of the negative control substance groups. On the other hand, in the positive control substance groups, the skin reactions of erythema, incrustation, or edema were found in all the animals throughout the entire study period.
In the test solution groups, a weak positive skin reaction was found at the provoking concentration of 100% whereas no positive skin reactions were found at the provoking concentrations of 25% and 50% throughout the entire study period.
Accordingly, a potential to induce delayed-type hypersensitivity (sensitization) of the test substance under the conditions in this study was found at the provoking concentration of 100% as a weak positive case, suggesting the result to suspect sensitization. However, it was negative at the provoking concentrations of 25% and 50%, and it should not present any problem as the extent of the observed effect was very weak as compared to that in the positive control substances.
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