Registration Dossier
Registration Dossier
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EC number: 942-166-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- available data was used which included a non-LLNA method.
Test material
- Reference substance name:
- Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid
- EC Number:
- 942-166-5
- Cas Number:
- 922708-02-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid
- Reference substance name:
- Glyceryl Behenate/isostearate/Eicosadioate
- IUPAC Name:
- Glyceryl Behenate/isostearate/Eicosadioate
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Nomcort SG
- Substance type: organic
- Physical state: solid
- Analytical purity: not stated
- Lot/batch No.: L060725
- Expiration date of the lot/batch: July 25 2009
- Stability under test conditions: not stated
- Storage condition of test material: room temperature, air tight
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc., 3371-8 Kotoh-cho, Hamamatsu, Shizuoka Prefecture, 431-1103 Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 343-397 g
- Housing: individual
- Diet: standard, ad libitum
- Water: filtered and sterilitzed drinking water, ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.6 - 23.3
- Humidity (%): 38.2 - 63.8
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % Test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % Test substance
- No. of animals per dose:
- 20 in test group, 10 in control
- Details on study design:
- RANGE FINDING TESTS: performed
- tested concentrations: 100%, 50%, 25%, 12.5% 6.25%, 3.13%
- vehicle: olive oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: dorsal area
- Frequency of applications: Day 1, Day 7 and Day 14
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: left and right flank
- Concentrations: 100 % Test substance
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- olive oil
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-Dinitrobenzene
Results and discussion
- Positive control results:
- clearly positive reactions were noted. The positive control is thus assessed valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 % CDNB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Magnusson & Kligman grading score
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 % CDNB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Magnusson & Kligman grading score
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results obtained in this study, it was concluded that Nomcort SG is not a skin sensitizer under the conditions of this study.
- Executive summary:
This study was designed to evaluate the skin sensitization of Nomcort SG using the Buehler test protocol. The test groups consisted of test substance group (20 animals) and control group (10 animals).
In the first, second and third induction for the test substance group, 100% test substance was held in contact with thee skin by an occlusive dressing for 6 hours. In two weeks, the flanks in the left and right were challenged with 100% test substance and olive oil, respectively, which were occlusively dressed for 6 hours.
In the first, second and third induction for the control group, olive oil was held in contact with the skin by an occlusive dressing for 6 hours. In two weeks, the left and right flanks were challenged with 100% test substance and olive oil, respectively, which were occlusively dressed for 6 hours.
As a result of the study, there were no skin reactions from any challenge sites on the test substance group and control group.
Abnormal clinical signs and body weight changes by the test substance were not observed in all animals during the observation period.
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