2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated

Endpoint summary

Description of key information

Skin Irritation:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.

2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated was estimated to be not irritating to rabbit skin.

Eye Irritation:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential for target substance.

2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated was estimated to be not irritating to rabbit eyes

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 based on structurally similar substances

Justification for type of information:

Weight of evidence based on structurally similar substances

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 based on structurally similar substances

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-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated- IUPAC name: 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated- Molecular formula: C40H36N4O1 - Molecular wt. : 588.76 g/mole- smiles : Cc1ccccc1N=Nc2ccc(c(C)c2)N=Nc3c4ccc(C(C)c5ccccc5)cc4cc(C(C)c6ccccc6)c3O- Substance type: Organic- Physical state: solid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALSSource: No dataAge at study initiation: No dataWeight at study initiation: 3 kg Fasting period before study: No dataHousing: singly housed, in suspended cagesDiet (e.g. ad libitum): Purina Rabbit Chow, ad libitumWater (e.g. ad libitum): water, ad libitumAcclimation 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 vehicle

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:

2 weeks

Observation period:

2 weeks

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 irritation observed

Interpretation of results:

other: not irritating

Conclusions:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated was estimated to be not irritating to rabbit skin.

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-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated.

A study was performed by JAMES E. FULTON, JR 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, it can be concluded that the target chemical 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.

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 based on structurally similar substances

Justification for type of information:

Weight of evidence based on structurally similar substances

Reason / purpose for cross-reference:

read-across: supporting information

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 based on structurally similar substances

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-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated- IUPAC name: 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated- Molecular formula: C40H36N4O1 - Molecular wt. : 588.76 g/mole- smiles : Cc1ccccc1N=Nc2ccc(c(C)c2)N=Nc3c4ccc(C(C)c5ccccc5)cc4cc(C(C)c6ccccc6)c3O- Substance type: Organic- Physical state: solid

Species:

other: rabbits and guinea pigs

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

100 microliters, aqueous solution

Duration of treatment / exposure:

no data available

Observation period (in vivo):

no data available

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

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:

other: no data available

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:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated was estimated to be not irritating to rabbit eyes.

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-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated.

The ocular irritation potential of the structurally similar read across chemical was assessed (OECD SIDS, SIAM 9, 29/06/1999) in rabbits. The study was performed as per OECD 405 Guidelines. 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, it can be considered to be not irritating to rabbit eyes.

This result is suptely on ported by experimental study summarized in Scientific Committee on Cosmetology (seventh series), for the structurally similar read across chemical. 100 µl of undiluted chemical was instilled in the eyes of rabbits and observed for signs of irritation (duration of exposure not mentioned).No signs of irritation were observed, so the test chemical

can be considered to be not irritating to rabbit eyes.

The above experimental data was supported by study summarized in Scientific Committee on Cosmetology (seventh series) for the structurally similar read across chemical. 0.8 mg of test chemical in an aqueous solution was instilled into the eyes of guinea pigs and observed for signs of irritation. No signs of irritation were observed in the guinea pigs when exposed to the test chemical. Hence, the test chemical was considered to be not irritating to 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 the target chemical 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 eyes and 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-naphthalenol, 1 -[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated.

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, it can be concluded that the target chemical 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 studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of 2-naphthalenol, 1-[[2 -methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated.

The ocular irritation potential of the structurally similar read across chemical was assessed in rabbits. The study was performed as per OECD 405 Guidelines. 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, it can be considered to be not irritating to rabbit eyes.

This result is supported by experimental study summarized in Scientific Committee on Cosmetology (seventh series), for the structurally similar read across chemical. 100 µl of undiluted chemical was instilled in the eyes of rabbits and observed for signs of irritation (duration of exposure not mentioned).No signs of irritation were observed, so the test chemical can be considered to be not irritating to rabbit eyes.

The above experimental data was supported by study summarized in Scientific Committee on Cosmetology (seventh series) for the structurally similar read across chemical. 0.8 mg of test chemical in an aqueous solution was instilled into the eyes of guinea pigs and observed for signs of irritation. No signs of irritation were observed in the guinea pigs when exposed to the test chemical. Hence, the test chemical was considered to be not irritating to 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 the target chemical 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 eyes and 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 that 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated can be not irritating to skin and eyes.

Hence by applying the weight of evidence approach, 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated can be considered to be not irritating to skin and eyes. It can be classified under the category “Not Classified” as per CLP regulation.