Registration Dossier

Skin irritation:

The skin irritation potential of Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated using OECD QSAR toolbox v 3.4 with logPow as the primary descriptor. Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated to be not irritating to the skin of rabbit. Based on the estimated results, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate can be considered to be not irritating to skin and can be classified under the category “ Not Classified ” as per CLP regulation.

Eye irritation:

The eye irritation potential of Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated using OECD QSAR toolbox v 3.4 with logPow as the primary descriptor. Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated to be not irritating to the eye of rabbit. Based on the estimated results, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate can be considered to be not irritating to eye and can be classified under the category “ Not Classified ” as per CLP regulation.

Reference

Endpoint:

skin irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

Data is predicted using OECD QSAR toolbox version 3.4 and QMRF report has been attached

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Prediction was done by using OECD QSAR toolbox v3.4

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (IUPAC name): Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate
- Common name: Acid Red 151
- Molecular formula: C22H15N4O4S.Na
- Molecular weight: 455.448 g/mol
-Physical state: red to brown powder
- Smiles notation: c12c(\N=N\c3ccc(\N=N\c4ccc(S(O)(=O)=O)cc4)cc3)c(ccc1cccc2)O.[Na+]
- InChl: 1S/C22H16N4O4S.Na/c27-21-14-5-15-3-1-2-4-20(15)22(21)26-25-17-8-6-16(7-9-17)23-24-18-10-12-19(13-11-18)31(28,29)30;/h1-14,27H,(H,28,29,30);/q;+1/b24-23+,26-25+;
- Substance type: Organic

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data available

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

No data avilable

Duration of treatment / exposure:

No data avilable

Observation period:

No data avilable

Number of animals:

No data avilable

Details on study design:

No data avilable

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: No data avilable

Reversibility:

not specified

Remarks on result:

no indication of irritation

Estimation method: Takes mode value from the 6 nearest neighbours
Domain logical expression:Result: In Domain

((((((((((("a" or "b" or "c" ) and ("d" and ( not "e") ) ) and "f" ) and ("g" and ( not "h") ) ) and ("i" and ( not "j") ) ) and "k" ) and "l" ) and "m" ) and ("n" and ( not "o") ) ) and ("p" and ( not "q") ) ) and ("r" and "s" ) )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo by DNA binding by OECD

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Strong binder, OH group by Estrogen Receptor Binding

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Acid moiety AND Phenols AND Salt by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo by DNA binding by OECD

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Michael addition OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Alkyl phenols OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Arenes OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Hydroquinones OR Michael addition >> Polarised Alkenes-Michael addition OR Michael addition >> Polarised Alkenes-Michael addition >> Alpha, beta- unsaturated ketones OR No alert found OR SN1 >> Iminium Ion Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines OR SN1 >> Nitrenium Ion formation >> Aromatic nitro OR SN1 >> Nitrenium Ion formation >> Primary aromatic amine OR SN1 >> Nitrenium Ion formation >> Secondary aromatic amine OR SN1 >> Nitrenium Ion formation >> Tertiary aromatic amine OR SN1 >> Nitrenium Ion formation >> Unsaturated heterocyclic azo by DNA binding by OECD

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as No superfragment by Superfragments ONLY

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Aromatic diazo AND H-acceptor-path3-H-acceptor by in vivo mutagenicity (Micronucleus) alerts by ISS

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as 1,3-dialkoxy-benzene OR alpha,beta-unsaturated carbonyls OR Aromatic N-acyl amine OR Hydrazine OR No alert found OR Polycyclic Aromatic Hydrocarbons by in vivo mutagenicity (Micronucleus) alerts by ISS

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Group 17 - Halogens Cl OR Group 17 - Halogens F,Cl,Br,I,At OR Group 2 - Alkaline Earth Be,Mg,Ca,Sr,Ba,Ra by Chemical elements

Domain logical expression index: "k"

Similarity boundary:Target: Oc1ccc2ccccc2c1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "l"

Similarity boundary:Target: Oc1ccc2ccccc2c1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1
Threshold=80%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "m"

Similarity boundary:Target: Oc1ccc2ccccc2c1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1
Threshold=60%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "n"

Referential boundary: The target chemical should be classified as Anion AND Aromatic compound AND Azo compound AND Cation AND Hydroxy compound AND Phenol AND Sulfonic acid derivative by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "o"

Referential boundary: The target chemical should be classified as Amine by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "p"

Referential boundary: The target chemical should be classified as Alcohol, olefinic attach [-OH] AND Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, aromatic attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Olefinic carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfonate, aromatic attach [-SO2-O] by Organic functional groups (US EPA)

Domain logical expression index: "q"

Referential boundary: The target chemical should be classified as Ortho-hydroxy to misc. -CO- by Organic functional groups (US EPA)

Domain logical expression index: "r"

Parametric boundary:The target chemical should have a value of log Kow which is >= -0.233

Domain logical expression index: "s"

Parametric boundary:The target chemical should have a value of log Kow which is <= 3

Interpretation of results:

other: Not irritating

Conclusions:

Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was considered to be not irritating to skin.

Executive summary:

The skin irritation potential of Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated using OECD QSAR toolbox v 3.4 with logPow as the primary descriptor. Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated to be not irritating to the skin of rabbit. Based on the estimated results, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate can be considered to be not irritating to skin and can be classified under the category “ Not Classified ” as per CLP regulation.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

Data is predicted using OECD QSAR toolbox version 3.4 and QMRF report has been attached

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Prediction was done by using OECD QSAR toolbox v3.4

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (IUPAC name): Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate
- Common name: Acid Red 151
- Molecular formula: C22H15N4O4S.Na
- Molecular weight: 455.448 g/mol
-Physical state: red to brown powder
- Smiles notation: c12c(\N=N\c3ccc(\N=N\c4ccc(S(O)(=O)=O)cc4)cc3)c(ccc1cccc2)O.[Na+]
- InChl: 1S/C22H16N4O4S.Na/c27-21-14-5-15-3-1-2-4-20(15)22(21)26-25-17-8-6-16(7-9-17)23-24-18-10-12-19(13-11-18)31(28,29)30;/h1-14,27H,(H,28,29,30);/q;+1/b24-23+,26-25+;
- Substance type: Organic

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

No data available

Duration of treatment / exposure:

No data available

Observation period (in vivo):

No data available

Number of animals or in vitro replicates:

No data available

Details on study design:

No data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not specified

Reversibility:

not specified

Remarks on result:

no indication of irritation

Estimation method: Takes mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(((((((("a" or "b" or "c" ) and ("d" and ( not "e") ) ) and ("f" and ( not "g") ) ) and ("h" and ( not "i") ) ) and ("j" and ( not "k") ) ) and "l" ) and "m" ) and ("n" and "o" ) )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo by DNA binding by OECD

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Strong binder, OH group by Estrogen Receptor Binding

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Acid moiety AND Phenols AND Salt by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo by DNA binding by OECD

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Michael addition OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Alkyl phenols OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Arenes OR Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Hydroquinones OR Michael addition >> Polarised Alkenes-Michael addition OR Michael addition >> Polarised Alkenes-Michael addition >> Alpha, beta- unsaturated ketones OR No alert found OR SN1 >> Iminium Ion Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines OR SN1 >> Nitrenium Ion formation >> Aromatic nitro OR SN1 >> Nitrenium Ion formation >> Primary aromatic amine OR SN1 >> Nitrenium Ion formation >> Secondary aromatic amine OR SN1 >> Nitrenium Ion formation >> Tertiary aromatic amine OR SN1 >> Nitrenium Ion formation >> Unsaturated heterocyclic azo by DNA binding by OECD

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.4

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Acylation involving an activated (glucuronidated) carboxamide group OR Acylation >> Acylation involving an activated (glucuronidated) carboxamide group >> Carboxylic Acid Amides OR Acylation >> Acylation involving an activated (glucuronidated) ester group OR Acylation >> Acylation involving an activated (glucuronidated) ester group >> Arenecarboxylic Acid Esters OR Acylation >> Acylation involving an activated (glucuronidated) sulfonamide group OR Acylation >> Acylation involving an activated (glucuronidated) sulfonamide group >> Arenesulfonamides OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> Carboxylic Acid Amides OR Acylation >> Ester aminolysis OR Acylation >> Ester aminolysis >> Amides OR AN2 OR AN2 >> Michael addition to activated double bonds OR AN2 >> Michael addition to activated double bonds >> alpha,beta-Unsaturated Carbonyls and Related Compounds OR AN2 >> Michael type addition to activated double bond of pyrimidine bases OR AN2 >> Michael type addition to activated double bond of pyrimidine bases >> Pyrimidines and Purines OR AN2 >> Michael-type addition to quinoid structures OR AN2 >> Michael-type addition to quinoid structures >> Carboxylic Acid Amides OR AN2 >> Michael-type addition to quinoid structures >> N-Substituted Aromatic Amines OR AN2 >> Nucleophilic addition at polarized N-functional double bond OR AN2 >> Nucleophilic addition at polarized N-functional double bond >> Arenesulfonamides OR AN2 >> Schiff base formation with carbonyl group of pyrimidine and purine bases OR AN2 >> Schiff base formation with carbonyl group of pyrimidine and purine bases >> Pyrimidines and Purines OR SNAr OR SNAr >> Nucleophilic aromatic substitution on activated aryl and heteroaryl compounds OR SNAr >> Nucleophilic aromatic substitution on activated aryl and heteroaryl compounds >> Activated aryl and heteroaryl compounds by Protein binding by OASIS v1.4

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct Acylation Involving a Leaving group OR Acylation >> Direct Acylation Involving a Leaving group >> Acetates by Protein binding by OECD

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "k"

Referential boundary: The target chemical should be classified as Group 11 - Trans.Metals Cu,Ag,Au by Chemical elements

Domain logical expression index: "l"

Similarity boundary:Target: Oc1ccc2ccccc2c1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "m"

Similarity boundary:Target: Oc1ccc2ccccc2c1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1
Threshold=80%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "n"

Parametric boundary:The target chemical should have a value of log Kow which is >= -0.236

Domain logical expression index: "o"

Parametric boundary:The target chemical should have a value of log Kow which is <= 6.19

Interpretation of results:

other: Not irritating

Conclusions:

Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was considered to be not irritating to rabbit eye.

Executive summary:

The eye irritation potential of Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated using OECD QSAR toolbox v 3.4 with logPow as the primary descriptor. Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated to be not irritating to the eye of rabbit. Based on the estimated results, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate can be considered to be not irritating to eye and can be classified under the category “ Not Classified ” as per CLP regulation.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no adverse effect observed (not irritating)

Skin irritation:

In different studies, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo) benzene sulphonate has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with human data for target chemical Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate and its structurally similar read across substances Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate[CAS: 3567-66-6] and Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate; disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl) diazenyl]naphthalene-1-sulfonate(3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

The skin irritation potential of Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated using OECD QSAR toolbox v 3.4 with logPow as the primary descriptor. Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated to be not irritating to the skin of rabbit. Based on the estimated results, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate can be considered to be not irritating to skin and can be classified under the category “ Not Classified ” as per CLP regulation.

The above predicted data was supported by experimental study conducted by conducted(Sustainability Support Services (Europe) AB, 2016) ( Report no. SPL/122/023) to determine dermal irritation potential of structurally similar read across substanceDisodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate[CAS: 3567-66-6]

A study was designed and conducted to determine the dermal reaction profile of Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate (CAS: 3567-66-6) in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study.

The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.

The test item Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days.

The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal.

Hence, it was concluded that Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate (CAS: 3567-66-6) was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category-Not Classified” as per CLP Classification.

The above experimental study was further supported by experimental study conducted by Sustainability Support Services (Europe) AB, Sweden (2016) (Report no. SPL/122/027) for structurally similar read across substanceDisodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate; disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl) diazenyl]naphthalene-1-sulfonate(3567-69-9).

The study now reported was designed and conducted to determine the dermal reaction profile of Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo] naphthalenesulphonate in Sprague Dawley rats.

The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.

Animals exhibited normal body weight gain through the study period of 14 days.

Gross pathological examination did not reveal any abnormalities attributable to the treatment.

From the study, it can be concluded that the test substance ‘Disodium 4-hydroxy-3-[(4-sulphona tonaphthyl)azo] naphthalenesulphonate’ is nonirritant to the skin of Sprague Dawley rats when applied to the shorn skin of 5 male and 5 female animals at the tested dose level of 2000 mg/kg body weight.

Also the erythema and edema score of rats was calculated as 0. Thus it can be concluded that the substanceDisodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo] naphthalenesulphonate can be classified under non irritant category.

Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded that Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo) benzene sulphonate was not irritating to skin. Itcan be classified under the category “Not Classified” as per CLP regulation

Eye irritation:

In different studies, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo) benzene sulphonate has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with human data for target chemical Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate and its structurally similar read across substances ,Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate (633-96-5) and Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate[CAS: 3567-66-6] The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

The eye irritation potential of Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated using OECD QSAR toolbox v 3.4 with logPow as the primary descriptor. Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate was estimated to be not irritating to the eye of rabbit. Based on the estimated results, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate can be considered to be not irritating to eye and can be classified under the category “ Not Classified ” as per CLP regulation.

The above predicted data was supported by experimental study summarized in Scientific Committee on Consumer Safety SCCS OPINION ON Acid Orange 7 COLIPA n° C15;22 March 2011 for the structurally similar read across substances ,Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate (633-96-5).

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulphonate was used as a teat material to evaluate eye irritation potential .

The test material was administrated on the eye of 3 male rabbits in the concentration 100 mg . No sign of irritation was observed during experiment thus it is concluded that sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate dose not classify as eye irritant.

The above experimental data was further supported by experimental study summarized in Scientific Committee on Consumer Safety (SCCS)-SCCP/1102/07 for the structurally similar read across substance Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate[CAS: 3567-66-6]

A study was conducted to determine the irritation potential of Acid Red 33 on rabbit eyes.

0.2 ml of a 10% aqueous solution (20 mg) or suspension of the test material was applied twice daily, five times weekly, for four weeks to the conjunctival sac of one eye of each of a group of six or more albino rabbits (40 applications). One hour after each application, the eyes were examined for evidence of staining and the irritation was scored according to Draize.

The overall irritation score after 20 days of observation was 0.0. Hence, disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate was considered to be not irritating to rabbit eyes.

Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded that Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo) benzene sulphonate was not irritating to eye. Itcan be classified under the category “Not Classified” as per CLP regulation

Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded that Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo) benzene sulphonate was not irritating to skin and eye. It can be classified under the category “Not Classified” as per CLP regulation