Diphenylacetonitrile

Endpoint summary

Description of key information

Skin Sensitization:

The skin sensitization study of the test chemicalwas performed in 27 volunteers to determine its sensitization potential by maximization test. .All the 27 human volunteers did not show any signs of irritation or sensitization. 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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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:

Weight of evidence approach based on the available data of the read-across chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

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:

other: Study 2: Human; Study 3: 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 (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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin Sensitisation:

Various studies for read across substances of the target chemical were reviewed for skin sensitisation and are summarized 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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on all the observations and results from the read-across chemicals, the test chemical was not observed to have skin sensitization potential. Thus, the test chemical is not likely to classify as 'skin sensitizer' as per CLP criteria of classification.