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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
Weight of evidence approach based on the available data of the read-across chemicals.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 a secondary literature
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Equivalent or similar to OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
other: maximization test
Justification for non-LLNA method:
not specified.
Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No Data Available
Positive control results:
No Data Available
Reading:
1st reading
Group:
test chemical
Dose level:
2% in petrolatum
No. with + reactions:
0
Total no. in group:
27
Clinical observations:
No effects were observed.
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: The test chemical did not show any skin sensitization potential, since no positive reactions were observed at tested dose levels.
Conclusions:
Based on all the observations and results, it was concluded that the test chemical was is not likely to be sensitizing, when tested in 27 human volunteers.
Executive summary:

The skin sensitization study of the test chemical was performed in 27 volunteers to determine its sensitization potential by maximization test. The study was conducted by using 2% of the test chemical in petrolatum, which was used as vehicle and was applied on 27 volunteers and observations were made. All the 27 human volunteers did not show any signs of irritation or sensitization. Thus, from the above observations, the test chemical did not show any skin sensitization potential, since no positive reactions were observed at tested dose levels. Based on all the observations and results, it was concluded that the test chemical was is not likely to be sensitizing, when tested in 27 human volunteers.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
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 IUCLID dataset
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Equivalent or similar to OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
not specified.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No Data Available
Positive control results:
No Data Available
Reading:
1st reading
Group:
test chemical
Dose level:
2% in petrolatum
No. with + reactions:
0
Total no. in group:
35
Clinical observations:
No effects
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 2% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 35.0. Clinical observations: skin evaluation.
Interpretation of results:
other: The test chemical does not have a sensitization potential as there were no signs of irritation or sensitization in the tested animals.
Conclusions:
Based on all the observations and results, it was concluded that the test chemical is not likely to cause any sensitization in guinea pigs when tested in 35 animals.
Executive summary:

The skin sensitization study of the test chemical was performed in 35 guinea pigs to determine its sensitization potential. In this study, 2% of test chemical was in petrolatum, which was used as a vehicle was applied on guinea pigs and observations were made. After application of the test chemical, it was observed that no effect of the test chemical was observed in all the 35 animals that were tested. There was no signs of irritation or sensitization which was caused by the test chemical. Thus, based on all the observations and result, it was concluded that the test chemical is not likely to cause any sensitization in guinea pigs  when tested in 35 animals.

Data source

Reference
Reference Type:
other: Secondary literature
Title:
Assessment of skin sensitization potential of the test chemical.
Author:
Sustainability Support Services (Europe) AB
Year:
2019
Bibliographic source:
SSS_SkinSens_2019_86293

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Equivalent or similar to OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
not specified.

Test material

Constituent 1
Chemical structure
Reference substance name:
Diphenylacetonitrile
EC Number:
201-662-5
EC Name:
Diphenylacetonitrile
Cas Number:
86-29-3
Molecular formula:
C14H11N
IUPAC Name:
2,2-diphenylacetonitrile
Test material form:
not specified
Details on test material:
Name: Diphenylacetonitrile
Molecular Weight: 193.248 g/mol
Molecular Formula: C14-H11-N
SMILES: C(c1ccccc1)(c1ccccc1)C#N

In vivo test system

Test animals

Species:
other: Study 2: Human; Study 3: Guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No Data Available

Results and discussion

Positive control results:
No Data Available

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
2% in petrolatum (Study 2)
No. with + reactions:
0
Total no. in group:
27
Clinical observations:
No effects were observed. (Study 2)
Remarks on result:
no indication of skin sensitisation
Remarks:
Study 2
Reading:
1st reading
Group:
test chemical
Dose level:
2% in petrolatum (Study 3)
No. with + reactions:
0
Total no. in group:
35
Clinical observations:
No effects (Study 3)
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 2% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 35.0. Clinical observations: skin evaluation.
Remarks:
Study 3

Applicant's summary and conclusion

Interpretation of results:
other: The test chemical was not considered to be sensitizing, since it did not show any effects on the tested subjects.
Conclusions:
Based on all the observations and results, it was considered that the test chemical was not sensitizing since it did not show any positive reactions in the tested subjects.
Executive summary:

Skin Sensitization:

The studies of skin sensitization of the test chemicals are as follows:

Study 2:

The skin sensitization studyof the test chemicalwas performed in 27 volunteers to determine its sensitization potential by maximization test. The study was conducted by using2% of the test chemical in petrolatum, which was used asvehicle and was applied on 27 volunteers and observations were made.All the 27 human volunteers did not show any signs of irritation or sensitization. Thus, from the above observations, the test chemical did not show any skin sensitization potential, since no positive reactions were observed at tested dose levels. Based on all the observations and results, it was concluded that the test chemical was is not likely to be sensitizing, when tested in 27 human volunteers.

Study 3:

The skin sensitization studyof the test chemicalwas performed in 35 guinea pigs to determine its sensitization potential. In this study,2%of test chemical was in petrolatum, which was used as a vehicle was applied on guinea pigs and observations were made. After application of the test chemical, it was observed that no effect of the test chemical was observed in all the 35 animals that were tested. There was no signs of irritation or sensitization which was caused by the test chemical. Thus, based on all the observations and result, it was concluded that the test chemical is not likely to cause any sensitization in guinea pigs  when tested in 35 animals.