1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates

Endpoint summary

Description of key information

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswill also tend to behave in a similar manner that of the read across substances. Therefore,1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswas estimated to be not sensitizing to skin. It can be 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:

other: Weight of evidence approach based on similar chemicals

Justification for type of information:

Weight of evidence approach based on similar chemicals

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on similar chemicals

Principles of method if other than guideline:

The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of 1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates

GLP compliance:

not specified

Type of study:

other: Weight of evidence approach based on similar chemicals

Specific details on test material used for the study:

- Name of test material: 1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates
- Molecular formula: C26H34N8O8
- Molecular weight: 586.597 g/mol
- Smiles notation: CC(=O)O{-}.N{+}c1ccc(N=Nc2cccc(N=Nc3ccc(N{+}.O{-}C(C)=O)cc3N{+}.O{-}C(C)=O)c2)c(N{+}.O{-}C(C)=O)c1
- Substance type: Organic
- Physical state: Solid

Species:

other: humans

Strain:

not specified

Sex:

male/female

Route:

epicutaneous, occlusive

Vehicle:

other: white petrolatum

Concentration / amount:

2%

Day(s)/duration:

48 hours

Adequacy of induction:

other: Patients with well established p-aminoazobenzene allergy were selected for the patch tests

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: white petrolatum

Concentration / amount:

2%

Adequacy of challenge:

not specified

No. of animals per dose:

32

Details on study design:

The study is based on weight of evidence approach from the read across values

Challenge controls:

The study is based on weight of evidence approach from the read across values

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

2% in white petrolatum

No. with + reactions:

0

Total no. in group:

32

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 structurally similar read across substances and applying the weight of evidence approach, it can be concluded that1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswill also tend to behave in a similar manner that of the read across substances. Therefore,1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswas estimated to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.
 

Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates.

 

 

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.

Both structurally similar chemicals failed to elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.

Hence, both structurally similar chemicals can be considered to be not sensitizing to skin.

 

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswill also tend to behave in a similar manner that of the read across substances. Therefore,1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswas estimated to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates.

 

 

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.

Both structurally similar chemicals failed to elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.

Hence, both structurally similar chemicals can be considered to be not sensitizing to skin.

 

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswill also tend to behave in a similar manner that of the read across substances. Therefore,1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetateswas estimated to be not sensitizing to skin. It can be 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

The results of the experimental studies from the structurally similar read across substances indicate a possibility that 1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates can be not sensitizing to skin.

Hence by applying the weight of evidence approach, 1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.