2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.

Endpoint summary

Description of key information

The substance 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. does not exhibit repeated dose toxicity via oral,inhalation or dermal route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Prediction report OECD QSAR Toolbox 3.2 Prediction

GLP compliance:

not specified

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

not specified

Duration of treatment / exposure:

90 days

Remarks:

Doses / Concentrations:
60,150 and 250 mg/kg/day
Basis:
no data

Control animals:

not specified

Observations and examinations performed and frequency:

General signs

Sacrifice and pathology:

Histopathology

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Organ weight findings including organ / body weight ratios:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Details on results:

No effects observed in any of the examined parameters

Dose descriptor:

NOEL

Effect level:

120.165 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Organ weight,body weight,General signs,haematological and histopathological findings

Critical effects observed:

not specified

The prediction was based on dataset comprised from the following descriptors: NOEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: Out of Domain

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

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Aryl AND Azo AND Fused carbocyclic aromatic AND Naphtalene AND Phenol AND Precursors quinoid compounds by Organic functional groups

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Azo AND Fused carbocyclic aromatic AND Naphtalene AND Overlapping groups AND Precursors quinoid compounds by Organic functional groups (nested)

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, aromatic attach [-OH] AND Olefinic carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] by Organic functional groups (US EPA)

Domain logical expression index: "d"

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

Domain logical expression index: "e"

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

Domain logical expression index: "f"

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

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Moderate binder, NH2 group OR Moderate binder, OH grooup OR Non binder, impaired OH or NH2 group OR Non binder, MW>500 OR Non binder, non cyclic structure OR Non binder, without OH or NH2 group OR Strong binder, NH2 group OR Weak binder, NH2 group OR Weak binder, OH group OR Very strong binder, OH group by Estrogen Receptor Binding

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Aryl AND Azo AND Fused carbocyclic aromatic AND Naphtalene AND Phenol AND Precursors quinoid compounds by Organic functional groups

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Azo AND Fused carbocyclic aromatic AND Naphtalene AND Overlapping groups AND Precursors quinoid compounds by Organic functional groups (nested)

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, aromatic attach [-OH] AND Olefinic carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] by Organic functional groups (US EPA)

Domain logical expression index: "k"

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

Domain logical expression index: "l"

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

Domain logical expression index: "m"

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

Domain logical expression index: "n"

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 OR Acylation >> Direct Acylation Involving a Leaving group >> Acyl halides (including benzyl and carbamoyl deriv.) OR Acylation >> Direct Acylation Involving a Leaving group >> Sulphonyl halides OR Acylation >> Isocyanates and Related Chemicals OR Acylation >> Isocyanates and Related Chemicals >> Isothiocyanates OR Acylation >> Isocyanates and Related Chemicals >> Thiocyanates-Acylation OR Acylation >> Ring Opening Acylation OR Acylation >> Ring Opening Acylation >> alpha-Lactams OR Acylation >> Ring Opening Acylation >> beta-Lactones-Acylation OR Michael addition OR Michael addition >> Polarised Alkenes OR Michael addition >> Polarised Alkenes >> Polarised alkene - aldehydes OR Michael addition >> Polarised Alkenes >> Polarised alkene - amides OR Michael addition >> Polarised Alkenes >> Polarised alkene - cyano OR Michael addition >> Polarised Alkenes >> Polarised alkene - esters OR Michael addition >> Polarised Alkenes >> Polarised alkene - ketones OR Michael addition >> Polarised Alkenes >> Polarised alkene - nitro OR Michael addition >> Polarised Alkenes >> Polarised alkene - pyridines OR Michael addition >> Polarised Alkenes >> Polarised alkene - sulfonate OR Michael addition >> Quinones and Quinone-type Chemicals OR Michael addition >> Quinones and Quinone-type Chemicals >> Pyranones (and related nitrogen chemicals) OR Michael addition >> Quinones and Quinone-type Chemicals >> Quinone-diimine OR Michael addition >> Quinones and Quinone-type Chemicals >> Quinone-imine OR Michael addition >> Quinones and Quinone-type Chemicals >> Quinone-methides OR Schiff Base Formers OR Schiff Base Formers >> Direct Acting Schiff Base Formers OR Schiff Base Formers >> Direct Acting Schiff Base Formers >> Mono-carbonyls OR SN2 OR SN2 >> Epoxides and Related Chemicals OR SN2 >> Epoxides and Related Chemicals >> Epoxides OR SN2 >> Ring Opening SN2 Reaction OR SN2 >> Ring Opening SN2 Reaction >> beta-Lactones-SN2 OR SN2 >> SN2 reaction at a sp2 carbon atom OR SN2 >> SN2 reaction at a sp2 carbon atom >> Polarised alkenes with a halogen leaving group OR SN2 >> SN2 reaction at a sulphur atom OR SN2 >> SN2 reaction at a sulphur atom >> Disulfides OR SN2 >> SN2 reaction at a sulphur atom >> Thiocyanates-SN2 OR SN2 >> SN2 reaction at a sulphur atom >> Thiols OR SN2 >> SN2 reaction at sp3 carbon atom OR SN2 >> SN2 reaction at sp3 carbon atom >> Alkyl diazo OR SN2 >> SN2 reaction at sp3 carbon atom >> Alkyl halides OR SN2 >> SN2 reaction at sp3 carbon atom >> Allyl acetates and related chemicals OR SN2 >> SN2 reaction at sp3 carbon atom >> alpha-Halobenzyls (and related cyano, sulfate and sulphonate subs. chem.) OR SN2 >> SN2 reaction at sp3 carbon atom >> alpha-Halocarbonyls OR SN2 >> SN2 reaction at sp3 carbon atom >> beta-Halo ethers OR SN2 >> SN2 reaction at sp3 carbon atom >> Phosphonates OR SNAr OR SNAr >> Nucleophilic aromatic substitution OR SNAr >> Nucleophilic aromatic substitution >> Activated halo-benzenes OR SNAr >> Nucleophilic aromatic substitution >> Activated halo-pyridines OR SNAr >> Nucleophilic aromatic substitution >> Halo-pyrimidines OR SNAr >> Nucleophilic aromatic substitution >> Halo-triazines by Protein binding by OECD

Domain logical expression index: "o"

Referential boundary: The target chemical should be classified as Aryl AND Azo AND Fused carbocyclic aromatic AND Naphtalene AND Phenol AND Precursors quinoid compounds by Organic functional groups

Domain logical expression index: "p"

Referential boundary: The target chemical should be classified as Azo AND Fused carbocyclic aromatic AND Naphtalene AND Overlapping groups AND Precursors quinoid compounds by Organic functional groups (nested)

Domain logical expression index: "q"

Referential boundary: The target chemical should be classified as Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, aromatic attach [-OH] AND Olefinic carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] by Organic functional groups (US EPA)

Domain logical expression index: "r"

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

Domain logical expression index: "s"

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

Domain logical expression index: "t"

Referential boundary: The target chemical should be classified as No alert found by DNA binding by OASIS v.1.1

Domain logical expression index: "u"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct acyation involving a leaving group OR Acylation >> Direct acyation involving a leaving group >> Geminal Polyhaloalkanes OR Elimination (E2) OR Elimination (E2) >> E2 elimination reaction with epoxide formation OR Elimination (E2) >> E2 elimination reaction with epoxide formation >> Haloalcohols OR Michael addition OR Michael addition >> alpha, beta-unsaturated carabonyl compounds OR Michael addition >> alpha, beta-unsaturated carabonyl compounds >> Alpha, Beta-Unsaturated Aldehydes OR Michael addition >> alpha, beta-unsaturated carabonyl compounds >> Four- and Five-Membered Lactones OR Michael addition >> Quinone type compounds OR Michael addition >> Quinone type compounds >> Quinoneimine Derivatives OR Michael addition >> Quinone type compounds >> Quinones OR Nucleophilic addition OR Nucleophilic addition >> Nucleophilic addition reaction with cycloisomerization OR Nucleophilic addition >> Nucleophilic addition reaction with cycloisomerization >> Hydrazine Derivatives OR Radical OR Radical >> Generation of reactive oxygen species OR Radical >> Generation of reactive oxygen species >> Coumarins OR Radical >> Generation of reactive oxygen species >> Thiols OR Radical >> Radical mechanism by ROS formation OR Radical >> Radical mechanism by ROS formation >> Diazenes OR Radical >> Radical mechanism by ROS formation >> Geminal Polyhaloalkanes OR Radical >> Radical mechanism by ROS formation >> Hydrazine Derivatives OR Radical >> Radical mechanism by ROS formation >> Nitro Compounds OR Radical >> Radical mechanism by ROS formation >> Nitroso compounds OR Radical >> Radical mechanism by ROS formation >> Organic Peroxy Compounds OR Radical >> Radical mechanism by ROS formation >> Quinones OR Radical >> Radical mechanism by ROS formation >> Specific Imine and Thione Derivatives OR Radical >> ROS formation after GSH depletion OR Radical >> ROS formation after GSH depletion >> Aromatic and Heterocyclic Primary Amines OR Radical >> ROS formation after GSH depletion >> Haloalcohols OR Radical >> ROS formation after GSH depletion >> Quinoneimine Derivatives OR Schiff base fomers OR Schiff base fomers >> Direct acting Schiff base formers OR Schiff base fomers >> Direct acting Schiff base formers >> Alpha, Beta-Unsaturated Aldehydes OR Schiff base fomers >> Direct acting Schiff base formers >> Geminal Polyhaloalkanes OR Schiff base fomers >> Direct acting Schiff base formers >> Specific Acetate Esters OR Schiff base fomers >> Multi-step Shiff base formation OR Schiff base fomers >> Multi-step Shiff base formation >> Haloalkanes Containing Electron-Withdrawing Groups OR SN1 OR SN1 >> Carbenium ion formation OR SN1 >> Carbenium ion formation >> Nitroso compounds OR SN1 >> Carbenium ion formation >> Polycyclic Aromatic Hydrocarbons OR SN1 >> Carbenium ion formation >> Specific Acetate Esters OR SN1 >> Glutathione-induced nitrenium ion formation OR SN1 >> Glutathione-induced nitrenium ion formation >> Nitroso compounds OR SN1 >> Nitrenium and/or Carbenium ion formation OR SN1 >> Nitrenium and/or Carbenium ion formation >> Urea Derivatives OR SN1 >> Nitrenium ion formation OR SN1 >> Nitrenium ion formation >> Aromatic and Heterocyclic Primary Amines OR SN1 >> Nitrenium ion formation >> N-hydroxylamines OR SN1 >> Nitrenium ion formation >> Nitro Compounds OR SN1 >> Nitrenium ion formation >> Sulfonyl Azides OR SN1 >> Non-enzymatic nitroso radical and/or nirtosonium cation formation OR SN1 >> Non-enzymatic nitroso radical and/or nirtosonium cation formation >> Nitroso compounds OR SN1 >> Non-enzymatic nitroso radical and/or nirtosonium cation formation >> Urea Derivatives OR SN2 OR SN2 >> Acylating agents OR SN2 >> Acylating agents >> Specific Acetate Esters OR SN2 >> Carbenium Ion Formation OR SN2 >> Carbenium Ion Formation >> Diazoalkanes OR SN2 >> Diazonium ion formation OR SN2 >> Diazonium ion formation >> Specific Imine and Thione Derivatives OR SN2 >> Direct Acting Epoxides and Related OR SN2 >> Direct Acting Epoxides and Related >> Epoxides, Aziridines OR SN2 >> Direct acylation involving a leaving group OR SN2 >> Direct acylation involving a leaving group >> Acyl Halides OR SN2 >> Epoxidation of Aliphatic Alkenes OR SN2 >> Epoxidation of Aliphatic Alkenes >> Polarized Haloalkene Derivatives OR SN2 >> Nucleophilic substitution at sp3 Carbon atom OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Geminal Polyhaloalkanes OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Haloalkanes Containing Electron-Withdrawing Groups OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Haloalkanes Containing Heteroatom OR SN2 >> P450-mediated epoxidation OR SN2 >> P450-mediated epoxidation >> Coumarins OR SN2 >> P450-mediated epoxidation >> Polarized Haloalkene Derivatives OR SN2 >> P450-mediated epoxidation >> Polycyclic Aromatic Hydrocarbons OR SN2 >> P450-mediated epoxidation >> Quinoline Derivatives OR SN2 >> Ring opening SN2 reaction OR SN2 >> Ring opening SN2 reaction >> Four- and Five-Membered Lactones OR SN2 >> SN2 at an activated sp2 (aromatic) carbon atom OR SN2 >> SN2 at an activated sp2 (aromatic) carbon atom >> Quinoline Derivatives OR SN2 >> SN2 at sp3 and activated sp2 carbon atom OR SN2 >> SN2 at sp3 and activated sp2 carbon atom >> Polarized Haloalkene Derivatives OR SN2 >> SN2 at sp3-carbon atom OR SN2 >> SN2 at sp3-carbon atom >> Alkylphosphates, Alkylthiophosphates and Alkylphosphonates OR SN2 >> SN2 at sp3-carbon atom >> Specific Acetate Esters OR SN2 >> SN2 at sulfur atom OR SN2 >> SN2 at sulfur atom >> Sulfonyl Halides by DNA binding by OASIS v.1.1

Domain logical expression index: "v"

Referential boundary: The target chemical should be classified as Not bioavailable by Lipinski Rule Oasis

Domain logical expression index: "w"

Similarity boundary:Target: c1(O)c(N=Nc2c(C)cc(N=Nc3c(C)cccc3)cc2)c2c(cccc2)cc1
Threshold=20%,
Dice(Atom centered fragments)

Domain logical expression index: "x"

Parametric boundary:The target chemical should have a value of log Kow which is >= 5.91

Domain logical expression index: "y"

Parametric boundary:The target chemical should have a value of log Kow which is <= 6.96

Conclusions:

The NOEL for 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. is estimated to be 360.496307373 mg/kg bw/day for rat for duration 28 days this subacute value when converted to subchronic value is equivalent to 120.1654 mg/kg bw/day for 90days duration using the toolbox version 3.1.

Executive summary:

The NOEL for 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. is estimated to be 360.496307373 mg/kg bw/dayfor rat for duration 28 days this subacute value when converted to subchronic value is equivalent to 120.1654 mg/kg bw/dayfor90days durationusing the toolbox version 3.1. The data is estimated to be based on the data summarized below

CAS no.	End point	Value	Species	Doses	Duration	Effects	Remarks
1843-05-6	NOEL	1000 mg/kg/day	Rat	Minimum dose-20 mg/kg/day Maximum dose-1000 mg/kg/day	28 days	General signs,body weight,mortality	-
104-40-5	NOEL	72 mg/kg/day	Rat	10 to 100 mg/kg/day	28 days	No effects on growth,hormones and morphology	-
25154-52-3	NOEL	224 mg/kg/day 172 mg/kg/day	Rat	60,150 and 250 mg/kg/day	28 days	Organ weight,body weight	-
84852-15-3	NOEL	211 mg/kg/day	Rat	10 ,50 and 250 mg/kg/day	28 days	General signs,haematological and histopathological findings	-
96-76-4	NOEL	273 mg/kg/day	Rat	5 to 300 mg/kg/day	28 days	General signs, histopathological findings,urinalysis,organ weight,food consumption	-
140-66-9	NOEL	263 mg/kg/day	Rat	15 to 300 mg/kg/day	28 days	General signs	-

 

All the valueswhen equalized to 90 days duration by using conversion factor of 3, the values are summarized as follows

Conversion-

CAS no.	End point	Value	Species	Duration
1843-05-6	NOEL	333.333mg/kg/day	Rat	90 days
104-40-5	NOEL	36mg/kg/day	Rat	90 days
25154-52-3	NOEL	74.66666mg/kg/day 57.3333 mg/kg/day	Rat	90 days
84852-15-3	NOEL	70.3333mg/kg/day	Rat	90 days
96-76-4	NOEL	91mg/kg/day	Rat	90 days
140-66-9	NOEL	87.666mg/kg/day	Rat	90 days

 

Thus the calculated NOEL of analogues for 90 days for the species rat is within the range of36 – 333.333mg/kg/day. Thus the predicted NOEL value is (calculated to be)120.1654 mg/kg bw/daywith 90 days for rat (harmonized using assessment factors) falls within the domain using Log Kow as the descriptor and justified to be used as NOEL for further DNEL calculation for the purpose of risk assessment. Also it does not impact the classification of the substance thus the predicted value considered to be acceptable.

 

Justified to be used as NOEL for the purpose of weight of evidence

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

120.165 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

Data from QSAR Toolbox versionn 3.2

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated dose toxicity oral-

Based on the various studies available with Klimish rating 2 and 4 for the target as well as read across substances for CAS 70879-65-1 also from category based on organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. The results for target as well as analogues are summarized as follows

Sr. No	End point	Value	Species	Route	Effects	Remarks
1.	NOEL	120.1654 mg/kg bw/day (nominal)	Rat	oral	Organ weight,body weight,General signs,haematological and histopathological findings	Predicted data
2.	NOAEL LOAEL	1000 mg/kg 2000 mg/kg	Mouse	oral	No effects on body weight and histopathology. decrease in body weight and histopathological effects.	NTP Study report RA-842-07-9
3.	NOAEL-Male NOAEL-Female	1250 mg/kg bw/day 2500 mg/kg bw/day	Rat	Oral	No adverse effect observed on mean body weights except a slight decrease in high dose males,no effect on survival rate and histopathology.	Study report RA-2783-94-0
4.	NOAEL-Male LOAEL-Female	1250 mg/kg bw/day 2500 mg/kg bw/day	Mouse	Oral	No adverse effect observed on mean body weights except a slight decrease in high dose males,no effect on survival rate and histopathology.Mean body weights of male and female mice administered the high dose were slightly lower, hepatocellular carcinomas in high-dose males (32%)	Study report RA-2783-94-0
5.	NOAEL	2000 mg/kg bw/day	Rat	Oral	No carcinogenic or toxic effect reported.	Publication RA-2783-94-0

 

Based on the studies summarized in the above table it can be observed that NOAEL of target and readacross varies from 120 mg/kg bw/day-2500 mg/kg bw/day.Also the LOAEL value of readacross ranges from 2000-2500mg/kg bw/day which is a conservative value and falls within the above range. Following are the parameters on which no effects/effects were observed-

-General signs,haematological and histopathological findings

- No carcinogenic or toxic effect reported.

-Mean body weights of male and female mice administered the high dose were slightly  lower, hepatocellular carcinomas in high-dose males (32%)

 

Thus based on above values it can be concluded that substance CAS 70879-65-1 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. is expected to show the similar toxicological effect based on the effects observed on the other category members. Since no effective dose value is greater than 120.1654 mg/kg bw/day thus based on this value it can be concluded that substance 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. is considered to be not toxic to repeated dose via oral route for the above mentioned dose. Also there are no known evidence of adverse effect to Human of CAS 70879-65-1 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.as well as mechanistic trigger does not indicates any concern of test substance on toxicity to human. Repeated dose toxicity inhalation- Considering the very low vapour pressure of 0.00000000061 Pa estimated for 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs, there shall be negligible exposure of living organisms to this chemical via the inhalation route. Hence this end point was considered for waiver. Repeated dose toxicity dermal- There are studies that indicate the acute dermal toxicity (LD50) of 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs on rat to be greater than 2000 mg/kg body weight. Also, th chemical is not irritating to skin. Thus indicating that substance will not be toxic via repeated dose dermal route hence consideired to be waived off.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

The NOEL  for 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. is estimated to be 360.496307373 mg/kg bw/day for rat for duration 28 days  this subacute value when converted to subchronic value is equivalent to 120.1654 mg/kg bw/day for 90days duration based on this value it can be concluded that 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs is not toxic substance via oral route.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

Considering the very low vapour pressure of 0.00000000061 Pa estimated for 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs, there shall be negligible exposure of living organisms to this chemical via the inhalation route. Hence this end point was considered for waiver.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:

Considering the very low vapour pressure of 0.00000000061 Pa estimated for 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs, there shall be negligible exposure of living organisms to this chemical via the inhalation route. Hence this end point was considered for waiver.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:

There are studies that indicate the acute dermal toxicity (LD50) of 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs on rat to be greater than 2000 mg/kg body weight. Also, th chemical is not irritating to skin. Thus indicating that substance will not be toxic via repeated dose dermal route hence consideired to be waived off.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:

There are studies that indicate the acute dermal toxicity (LD50) of 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs on rat to be greater than 2000 mg/kg body weight. Also, th chemical is not irritating to skin. Thus indicating that substance will not be toxic via repeated dose dermal route hence consideired to be waived off.

Justification for classification or non-classification

The substance2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.is not expected toshow repeated dose toxicity effect for oral inhalation or dermal route and thus will not be considered for further classification.