Registration Dossier

Administrative data

Description of key information

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:
read-across: supporting information
Related information:
Composition 1
Reason / purpose:
read-across: supporting information
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on structurally 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 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on structurally similar chemicals
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material : 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]
- Common name: C.I. Solvent Yellow 107
- IUPAC name : 2-[(E)-2-(4-{4-[(E)-2-(2-hydroxy-5-nonylphenyl)diazen-1-yl]-3-methylphenyl}-2-methylphenyl)diazen-1-yl]-4-nonylphenol
- Molecular formula : C44H58N4O2
- Molecular weight : 674.9682 g/mol
- Smiles notation : CCCCCCCCCC1=CC(=NNC2=C(C=C(C=C2)C3=CC(=C(C=C3)NN=C4C=C(C=CC4=O)CCCCCCCCC)C)C)C(=O)C=C1
- InChl : 1S/C44H58N4O2/c1-5-7-9-11-13-15-17-19-35-21-27-43(49)41(31-35)47-45-39-25-23-37(29-33(39)3)38-24-26-40(34(4)30-38)46-48-42-32-36 (22-28-44(42)50)20-18-16-14-12-10-8-6-2/h21-32,49-50H,5-20H2,1-4H3/b47-45+,48-46+
- Substance type: Organic
- Physical state: Solid (Off white to slight yellow)
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
The study is based on weight of evidence approach from the read across values
Route:
epicutaneous, occlusive
Vehicle:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
The study is based on weight of evidence approach from the read across values
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
Group:
test group
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 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]will also tend to behave in a similar mannerthat of the read across substances. Therefore the target chemical was estimated to be not sensitizing to skinand 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 chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol].

Magnusson & Kligman guinea pig maximization test (GPMT) was conducted on six Female Hartley strain albino guinea pigs to assess the dermal sensitization potential of the test chemical.

Induction treatment consisted of 3 intra-dermal injections and one topical induction. On day 0, a row of 3 injections of 0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil was given on each side of the 2x4 cm clipped neck . In order to enhance the sensitization, sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction. On day 7, 0.5 g of 1.0% test chemicals in petrolatum were occlusively applied for 48 h. The samples were covered with lint pads which were lining with Blenderm tape.

The challenge treatment was given by open topical application. On day 21, the flank regions of the animals were clipped and shaved, and then 0.03 ml of test material in acetone was applied to the skin for 72 hrs. Observations were made 48 hrs after challenge. No positive reaction was elicited at the concentrations tested.

Hence, the test chemical was considered to be not sensitizing to guinea pig’s skin.

This study is supported by the results of the Modified guinea pig maximization test performed to determine the allergenic potential of the structurally similar chemical.

The test chemical was applied epicutaneously to the skin of guinea pigs and observed for dermal reactions.

The test chemical produced a sensitizing reaction when produced according to a traditional manufacturing process. When the contaminants were isolated , they were identified to be the reason for that reaction, because they showed sensitization effects. The purified test chemical and test chemical produced by modified manufacturing process didn’t cause any sensitization.

Hence, it was considered that the purified test chemical was indeed not sensitizing to guinea pig skin

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]will also tend to behave in a similar mannerthat of the read across substances. Therefore the target chemical was estimated to be not sensitizing to skinand 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 chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol].

Magnusson & Kligman guinea pig maximization test (GPMT) was conducted on six Female Hartley strain albino guinea pigs to assess the dermal sensitization potential of the test chemical.

Induction treatment consisted of 3 intra-dermal injections and one topical induction. On day 0, a row of 3 injections of 0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil was given on each side of the 2x4 cm clipped neck . In order to enhance the sensitization, sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction. On day 7, 0.5 g of 1.0% test chemicals in petrolatum were occlusively applied for 48 h. The samples were covered with lint pads which were lining with Blenderm tape.

The challenge treatment was given by open topical application. On day 21, the flank regions of the animals were clipped and shaved, and then 0.03 ml of test material in acetone was applied to the skin for 72 hrs. Observations were made 48 hrs after challenge. No positive reaction was elicited at the concentrations tested.

Hence, the test chemical was considered to be not sensitizing to guinea pig’s skin.

This study is supported by the results of the Modified guinea pig maximization test performed to determine the allergenic potential of the structurally similar chemical.

The test chemical was applied epicutaneously to the skin of guinea pigs and observed for dermal reactions.

The test chemical produced a sensitizing reaction when produced according to a traditional manufacturing process. When the contaminants were isolated , they were identified to be the reason for that reaction, because they showed sensitization effects. The purified test chemical and test chemical produced by modified manufacturing process didn’t cause any sensitization.

Hence, it was considered that the purified test chemical was indeed not sensitizing to guinea pig skin

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]will also tend to behave in a similar mannerthat of the read across substances. Therefore the target chemical was estimated to be not sensitizing to skinand 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 that2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]can be not sensitizing to skin.Hence by applying the weight of evidence approach,2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation