4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide

Endpoint summary

Description of key information

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on various test chemicals

Justification for type of information:

Weight of evidence approach based on various test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on various test chemicals

Principles of method if other than guideline:

Weight of evidence approach based on various test chemicals

GLP compliance:

not specified

Type of study:

other: Weight of evidence approach based on various test chemicals

Justification for non-LLNA method:

no data available

Species:

other: humans

Strain:

not specified

Sex:

male/female

Route:

epicutaneous, occlusive

Vehicle:

other: white petrolatum

Concentration / amount:

2% in white petrolatum

Adequacy of induction:

not specified

Route:

other: epicutaneous

Vehicle:

water

Concentration / amount:

20% dye in water

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: white petrolatum

Concentration / amount:

2% in white petrolatum

Adequacy of challenge:

not specified

No.:

#1

Route:

other: epicutaneous

Vehicle:

water

Concentration / amount:

20% dye in water

Adequacy of challenge:

not specified

No. of animals per dose:

1. 32 patients
2. 15 patients

Details on study design:

The data is based on weight of evidence approach based on various test chemicals

Challenge controls:

no data available

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

No. with + reactions:

0

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Executive summary:

The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

 

A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.

The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.

The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.

Hence, the test chemical can be considered to be not sensitizing to skin.

This is supported by the results of another patch test performed to determine the skin sensitization potential of the test chemical.

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water was applied on the skin of 15 patients in Finn Chambers. The skin reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.

None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

 

A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.

The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.

The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.

Hence, the test chemical can be considered to be not sensitizing to skin.

This is supported by the results of another patch test performed to determine the skin sensitization potential of the test chemical.

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water was applied on the skin of 15 patients in Finn Chambers. The skin reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.

None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data for the various test chemicals and applying the weight of evidence approach,it can be concluded that the test chemical will also behave in similar manner.

The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.