N,N-diethylaniline

Endpoint summary

Description of key information

The skin sensitization potential of target chemical was assessedin various experimental studies which were conducted on guinea pigs and humans.The studies are based on in vivo experiments in guinea pigs for target chemicaland its structurally similar read across substances. Based on the available studies,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from authoritative database

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Skin sensitization test was conducted on guinea pigs to assess skin sensitization potential of test chemical.

GLP compliance:

no

Type of study:

not specified

Justification for non-LLNA method:

not specified

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Route:

other: epicutaneous

Vehicle:

not specified

Concentration / amount:

10%

Day(s)/duration:

not specified

Adequacy of induction:

not specified

No.:

#1

Route:

other: epicutaneous

Vehicle:

not specified

Concentration / amount:

1or 2%

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No. of animals per dose:

No data available.

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE

- Concentrations: 10%

B. CHALLENGE EXPOSURE
- Concentrations: 1or 2%
-

Positive control substance(s):

not specified

Reading:

rechallenge

Group:

test chemical

Dose level:

1or 2%

No. with + reactions:

0

Clinical observations:

No sensitization observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material was considered to be not sensitizing on guinea pig skin.

Executive summary:

The skin sensitization study was conducted in guinea pigs to observe the skin sensitization effects of test chemical.

 

In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of test chemical .

 

Since the test animals failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studieshas been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs for target chemicaland its structurally similar read across substancesthat have beensummarized as below;

 

The skin sensitization study of test chemical was conducted in guinea pigs to observe its skin sensitization effects. In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of test chemical. Since the test animals failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

 

The above result is supported by modified draize test conducted on guinea pigs to assess the skin sensitization potential of test chemical. In a this test, induction was carried out by means of four simultaneous intracutaneous injections of 2.5% test chemical solution above the axillary and inguinal lymph nodes. Intracutaneous challenge treatment was carried out on the opposite shaved flanks 14 days later using a 1% concentration. No known evidence of skin sensitization was observed in treated guinea pigs. Hence the test chemical was considered to be not sensitizing to the skin of treated guinea pigs.

 

The overall results were further supported by the another skin sensitization study of test chemical performed in 10 female guinea pigs by using modified FCA and guinea pig maximization test. In the induction phase, the test compound was dissolved in FCA, 15 mg in 4 ml. Then physiological saline was added and an emulsion was prepared by mixing the material by mean of a 5ml syringe, until emulsification was completed. The intradermal injections of 6 X 0.10-0.15 ml of this emulsion was applied in a semi-circle arc on clipped and shaved shoulder from left to right in such a way that whole quantity of emulsion was used up for 10 animals. This procedure was repeated on 5thand 9thday. , leaving a gap of 2-3 cm between the rows of injection. After induction phase of 11 days, animals were challenged by applying 0.05ml of test chemical in a sub irritant concentration, with further dilution to the clipped and shaved skin of the right flank of the treated animals, allowing 5 mins for drying. Control animals were also used. Mean Observations were made after 24, 48 and 72 hours. As no sensitization effects were observed, the test material can be considered as non -sensitizing to the female guinea pigs.

 

Based on the available data for the target chemical, supporting studies and read across substance,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance and its structurally similar read across substancewere observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.