Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Endpoint summary

Description of key information

Skin Sensitization

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate will also tend to behave in a similar that of the read across chemicals. Therefore the target chemical was estimated to be not sensitizing to skin and 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:

other: Weight of evidence approach based on structurally similar chemicals

Justification for type of information:

Weight of evidence approach based on structurally 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 barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate

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: barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Molecular formula: C18H14N2O6S.Ba- Molecular weight: 521.697 g/mol- Smiles notation: [Ba+2].c1c(c(c(c2ccccc12)\N=N\c1c(cc(cc1)C)S(=O)(=O)[O-])O)C(=O)[O-]- InChl: 1S/C18H14N2O6S.Ba/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Substance type: Organic- Physical State: Solid

Species:

other: humans, guinea pigs

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data available

Route:

epicutaneous, occlusive

Vehicle:

not specified

Adequacy of induction:

not specified

Route:

intradermal and epicutaneous

Vehicle:

CMC (carboxymethyl cellulose)

Concentration / amount:

5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline.

Day(s)/duration:

18hours

Adequacy of induction:

other: pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS)

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Adequacy of challenge:

not specified

No.:

#1

Route:

intradermal and epicutaneous

Vehicle:

CMC (carboxymethyl cellulose)

Day(s)/duration:

48 hours

Adequacy of challenge:

other: pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS)

No. of animals per dose:

1. 152.

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

Reading:

1st reading

Group:

test chemical

No. with + reactions:

0

Clinical observations:

no 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 that barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate will also tend to behave in a similar that of the read across chemicals. Therefore the target chemical was estimated to be not sensitizing to skin and it can be further classified under the category “Not Classified” as per CLP regulation. 

Executive summary:

Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal sensitization potential for barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate.

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on 15 patients in Finn Chambers and 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.

The above result is supported by a study conducted as per OECD 406 Guidelines performed on guinea pigs to assess the dermal sensitization potential of the structurally similar read across chemical. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed.

Hence the test chemical was considered to be not skin sensitizing in guinea pig.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate will also tend to behave in a similar that of the read across chemicals. Therefore the target chemical was estimated to be not sensitizing to skin and 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:

Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal sensitization potential for barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate.

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on15 patients in Finn Chambers and 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.

The above result is supported by a study conducted as per OECD 406 Guidelines performed on guinea pigs to assess the dermal sensitization potential of the structurally similar read across chemical. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed.

Hence the test chemical was considered to be not skin sensitizing in guinea pig.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that barium 3-hydroxy-4-[(4 -methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate will also tend to behave in a similar that of the read across chemicals. Therefore the target chemical was estimated to be not sensitizing to skin and 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

The results of the experimental studies from the structurally similar read across substances indicate a possibility that barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate can be not sensitizing to skin.

Hence by applying the weight of evidence approach, barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.