Registration Dossier

Administrative data

Description of key information

Skin Irritation

Based on the available data for the structurally similar read across substances and applying the weight ofevidence 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 manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Eye Irritation

Based on the available data for the structurally similar read across substances and applying the weight ofevidence 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 manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to eyesand it can be further classified under the category “Not Classified” as per CLP regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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 irritation potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]
GLP compliance:
not specified
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:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Age at study initiation: No data
Weight at study initiation: 3 kg
Fasting period before study: No data
Housing: singly housed, in suspended cages
Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
Water (e.g. ad libitum): water, ad libitum
Acclimation period: No data
Type of coverage:
other: Entire inner surface of one ear
Preparation of test site:
other: A colony of rabbits that had genetically good ears and which were free from mites were used for the assay
Vehicle:
other: The test chemical was mixed in propylene glycol at a 9 to 1 dilution for testing
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Dose of 1ml of the test material was applied once daily for five days per week for 2 weeks
Duration of treatment / exposure:
14 days
Observation period:
14 days
Number of animals:
3
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
14 d
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed
Interpretation of results:
other: not irritating
Conclusions:
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] will also tend to behave in the same manner as that of its structurally chemicals. Hence, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] can be considered to be not irritating 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 irritation potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol].

 

A study was performed to determine the Comedogenicity and irritancy potential of the structurally similar read across chemicals. The dyes were mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated (10% concentration). A colony of New Zealand albino rabbits that have genetically good ears and free from mites were used. Three rabbits, weighing two to three kilograms, were used for each assay. Animals were housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals were maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of the test material was applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control. The irritancy produced by repeated application of the chemical on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:

0 = No irritation; 1 = few scales, no Erythema; 2 = diffuse scaling, no Erythema; 3 = Generalized scaling

with Erythema; 4 = Scaling, Erythema and Edema; 5 = Epidermal necrosis and slough.

 

Both the structurally similar read across chemicals were graded 0 (no irritation observed). Hence, they can be considered to be not irritating to rabbit skin.

 

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] will also tend to behave in the same manner as that of its structurally chemicals. Hence, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] can be considered to be not irritating to skin. It can be classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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 read across chemicals
Justification for type of information:
Weight of evidence approach based on structurally similar read across 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 read across 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 ocular irritation potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]
GLP compliance:
not specified
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:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. 0.1 ml
2. undiluted test chemical
Duration of treatment / exposure:
1. 24 hours
2. 24 hours
Observation period (in vivo):
1. 1, 24, 48 and 72 hours
2. 24 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
1. 3
2. no data available
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed
Interpretation of results:
other: not irritating
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 irritating to eyesand 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 ocular irritation potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol].

A study was performed to determine the ocular irritation potential of the structurally similar read across chemical in accordance with OECD 405 Guidelines. 3 female New Zealand White rabbits were used for the study.

The test compound  in the amount of 0.1 ml applied in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball.  The eye lids were then gently held together for about one second to prevent the loss of the material.  The other eyes which remains untreated, served as control.

The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate. The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed. The Modified maximum average score (MMAS) of the test chemical was found to be 8.33.

Based on above results, it can be concluded that the test compound was practically non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the New Zealand White rabbits.

This result is supported by the experimental study performed as per OECD 405 Guidelines to assess the extent of ocular damage caused by the structurally similar chemical. The test chemical was instilled in the eyes of rabbits and exposed till 24 hours. No signs of irritation were observed after 24 hours exposure to the test chemical in rabbits.

Hence, the test chemical can be considered to be not irritating to rabbit eyes.

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 irritating to eyesand it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol].

 

A study was performed to determine the Comedogenicity and irritancy potential of the structurally similar read across chemicals. The dyes were mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated (10% concentration). A colony of New Zealand albino rabbits that have genetically good ears and free from mites were used. Three rabbits, weighing two to three kilograms, were used for each assay. Animals were housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals were maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of the test material was applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control. The irritancy produced by repeated application of the chemical on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:

0 = No irritation; 1 = few scales, no Erythema; 2 = diffuse scaling, no Erythema; 3 = Generalized scaling

with Erythema; 4 = Scaling, Erythema and Edema; 5 = Epidermal necrosis and slough.

 

Both the structurally similar read across chemicals were graded 0 (no irritation observed). Hence, they can be considered to be not irritating to rabbit skin.

 

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] will also tend to behave in the same manner as that of its structurally chemicals. Hence, 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] can be considered to be not irritating to skin. It can be classified under the category “Not Classified” as per CLP regulation.

Eye Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidenceapproach was applied to assess the ocular irritation potential of 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol].

A study was performed to determine the ocular irritation potential of the structurally similar read across chemical in accordance with OECD 405 Guidelines. 3 female New Zealand White rabbits were used for the study.

The test compound  in the amount of 0.1 ml applied in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball.  The eye lids were then gently held together for about one second to prevent the loss of the material.  The other eyes which remains untreated, served as control.

The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate. The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed. The Modified maximum average score (MMAS) of the test chemical was found to be 8.33.

Based on above results, it can be concluded that the test compound was practically non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the New Zealand White rabbits.

This result is supported by the experimental study performed as per OECD 405 Guidelines to assess the extent of ocular damage caused by the structurally similar chemical. The test chemical was instilled in the eyes of rabbits and exposed till 24 hours. No signs of irritation were observed after 24 hours exposure to the test chemical in rabbits.

Hence, the test chemical can be considered to be not irritating to rabbit eyes.

Based on the available data for the structurally similar read across substances and applying the weight ofevidence 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 manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to eyesand it can be further classified under the category “Not Classified” as per CLP regulation.

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 irritating to skin and eyes.

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 irritating to skin and eyes. It can be classified under the category “Not Classified” as per CLP regulation.