Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
2016
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

Constituent 1
Chemical structure
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
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