Registration Dossier
Registration Dossier
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EC number: 214-046-6 | CAS number: 1074-82-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Skin Sensitization test for CAS 17796-82-6
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 016
- Bibliographic source:
- High Production Volume (HPV) Challenge Program; 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Shelanski Repeated Insult Patch Test, 1953
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed on human to observe the skin sensitization effect.
- GLP compliance:
- no
- Type of study:
- patch test
Test material
- Reference substance name:
- N-(cyclohexylthio)phthalimide
- EC Number:
- 241-774-1
- EC Name:
- N-(cyclohexylthio)phthalimide
- Cas Number:
- 17796-82-6
- Molecular formula:
- C14H15NO2S
- IUPAC Name:
- 2-(cyclohexylsulfanyl)-1H-isoindole-1,3(2H)-dione
- Details on test material:
- - Name of test material (as cited in study report): 1H-Isoindole-1,3(2H)-dione, 2-(cyclohexylthio)-
- Molecular formula : C14H15NO2S
- Molecular weight: 261.36 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1H-Isoindole-1,3(2H)-dione, 2-(cyclohexylthio)-
- Molecular formula : C14H15NO2S
- Molecular weight: 261.36 g/mol
- Substance type: Organic
- Physical state: Solid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other:
- Remarks:
- Not applicable
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- 24 hour
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- 24 hour
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 53 Human volunteers
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 15
- Exposure period: 24 hrs
- Test groups: no data
- Control group: no data
- Site: no data
- Frequency of applications: 15 applications
- Duration: 24 hrs
- Concentrations: No data
B. CHALLENGE EXPOSURE
- No. of exposures: 24 hrs
- Day(s) of challenge: 10 days
- Exposure period: 24 hrs
- Test groups: No data
- Control group: No data
- Site: human skin
- Concentrations: No data
- Evaluation (hr after challenge): 24 hrs
OTHER: The dose level used in this study, 2 parts per hundred rubber (2 phr) is about five times higher than what is normally used in compounded rubber stocks. - Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 parts per hundred rubber stock (2 phr)
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- No sensitizing effects were observed
- Remarks on result:
- other: Not sensitizing; mild cumulative irritation
Any other information on results incl. tables
No sensitization was observed. Only mild cumulative irritation was observed in this study.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No sensitizing effects were observed for 1H-Isoindole-1,3(2H)-dione, 2-(cyclohexylthio)- when In vitro Shelanski Repeated Insult Patch Test was performed.
- Executive summary:
In vitro Shelanski Repeated Insult Patch Test was performed on human subjects to observe the skin sensitizing effects of 1H-Isoindole-1,3(2H)-dione, 2-(cyclohexylthio)-.
Patches, 1" square of the rubber stock were applied to the skin of 53 human volunteers and left in place for 24 hours. Readings were taken at the end of 24 hours, and the sites were rested for an additional 24 hours. Patches were reapplied and read again after 24 hours. Fifteen such applications were used. A 10-day rest period followed, and then the challenge application was applied for 24 hours.No positive reactions were observed following the initial application, any subsequent application or after the challenge application. Only mild cumulative irritation was observed in this study. The level used in this study, 2 parts per hundred rubber (2 phr) is about five times higher than what is normally used in compounded rubber stocks. Therefore 1H-Isoindole-1,3(2H)-dione, 2-(cyclohexylthio)- was considered to be non sensitizing in Human by in vitro Shelanski Repeated Insult Patch Test
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