Registration Dossier

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic nature of the test chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9).The studies are as mentioned below:

1.In a acute oral toxicity study,rats were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rats at 5000 mg/kg bw. Therefore,LD50 was considered to be > 5000 mg/kg bw,when rats were treated with test chemical orally.

2. Acute oral toxicity study was done in rats using test chemical.No mortality was observed at dose 2000 mg/kg bw. Hence,LD50 value was considered to be >2000 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised studies, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) and it’s structurally similar and closely related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(2-ethylhexyl)-1-[[2 -methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) cannot be classified for acute oral toxicity. Hence,based on the data available for the structurally similar and closely related across chemical,

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9)

is not likely to be toxic atleast in the dose range of >2000->5000 mg/Kg bw.

Acute inhalation toxicity:

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine has very low vapor pressure (8.07E-012 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.

Acute dermal toxicity:

Data available for the closely related read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9).The studies are as mentioned below:

1.In acute dermal toxicity study,10 male and female New Zealand white rabbits were treated with test chemical in the concentration of 2000 mg/kg bw according to OECD Guide-line 402 "Acute Dermal Toxicity"by dermal application for 14 days of observation period.No mortality was observed in treated rabbits at dose 2000 mg/kg bw.5 rabbits had abnormal defecation (soft stool, mucoid feces) on day 0 or 1. One of these animals also had wet, and subsequently, dry brown urogenital matting. These findings were considered to be a result of the bandage/restraint procedures used and not related to the test material. An additional spontaneaous occurrence of soft stool was noted on day 9 for one animal. There were no other findings. The test material induced generally very slight to slight erythema on all rabbits and very slight to slight edema on 8 rabbits. There was a single occurrence of moderate erythema at the day 1 observation. Desquamation was present on five sites by day 7. There were no other dermal findings. One site had very slight erythema at study termination (day 14). There were no remarkable changes or differences noted in body weights during the study. In necropsy findings, accessory splenic tissue, a common congenital abnormality in this strain of rabbit, was noted for four animals at the terminal necropsy. There were no other gross necropsy findings for all examined tissues.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rabbits were treated with test chemical by dermal application.

2.In acute dermal toxicity study,rabbits were treated with test chemical in the concentration of 5000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 5000 mg/kg bw.Therefore, LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.

Thus, based on the above summarised studies, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) and it’s closely related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) cannot be classified for acute dermal toxicity. Hence,based on the data available for the closely related across chemical,

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9)

is not likely to be toxic atleast in the dose range of >2000->5000 mg/Kg bw.

Reference

Endpoint:

acute toxicity: oral

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:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two acute oral toxicity studies as-
1.and 2. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

no

Specific details on test material used for the study:

- Name of the test material: N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Regulatory name: N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Molecular formula: C32H37N5
- Molecular weight: 491.6793 g/mol
- Smiles: CCCCC(CC)CNc1ccc2ccccc2c1/N=N/c3ccc(cc3C)/N=N/c4ccc(cc4)C
- InChI: 1S/C32H37N5/c1-5-7-10-25(6-2)22-33-31-19-15-26-11-8-9-12-29(26)32(31)37-36-30-20-18-28(21-24(30)4)35-34-27-16-13-23(3)14-17-27/h8-9,11-21,25,33H,5-7,10,22H2,1-4H3/b35-34+,37-36+
- Substance type: Organic
Physical form: Dark red clear liquid

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

1. not specified
2. not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

1. not specified
2. not specified

Doses:

1.5000 mg/kg bw
2.2000 mg/kg bw

No. of animals per sex per dose:

1. not specified
2. not specified

Control animals:

not specified

Details on study design:

1. not specified
2. not specified

Statistics:

1. not specified
2. not specified

Preliminary study:

1. not specified
2. not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 - <= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

1.No mortality was observed in treated rats at 5000 mg/kg bw
2.No mortality was observed in treated rats at 2000 mg/kg bw

Clinical signs:

1. not specified
2. not specified

Body weight:

1. not specified
2. not specified

Gross pathology:

1. not specified
2. not specified

Other findings:

1. not specified
2. not specified

Interpretation of results:

other: not classified

Conclusions:

The test chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) is not likely to be toxic atleast in the dose range of >2000->5000 mg/Kg bw.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic nature of the test chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9).The studies are as mentioned below:

1.In a acute oral toxicity study,rats were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rats at 5000 mg/kg bw. Therefore,LD50 was considered to be > 5000 mg/kg bw,when rats were treated with test chemical orally.

2. Acute oral toxicity study was done in rats using test chemical.No mortality was observed at dose 2000 mg/kg bw. Hence,LD50 value was considered to be >2000 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised studies, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) and it’s structurally similar and closely related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) cannot be classified for acute oral toxicity. Hence,based on the data available for the structurally similar and closely related across chemical,

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9)

is not likely to be toxic atleast in the dose range of >2000->5000 mg/Kg bw.

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimicsh 2 and from secondary source

Reference

Endpoint:: acute toxicity: inhalation
Data waiving:: other justification
Justification for data waiving:: other:

Quality of whole database:

waiver

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimicsh 2 and from secondary source

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic nature of the test chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9).The studies are as mentioned below:

1.In a acute oral toxicity study,rats were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rats at 5000 mg/kg bw. Therefore,LD50 was considered to be > 5000 mg/kg bw,when rats were treated with test chemical orally.

2. Acute oral toxicity study was done in rats using test chemical.No mortality was observed at dose 2000 mg/kg bw. Hence,LD50 value was considered to be >2000 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised studies, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) and it’s structurally similar and closely related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) cannot be classified for acute oral toxicity. Hence,based on the data available for the structurally similar and closely related across chemical,

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9)

is not likely to be toxic atleast in the dose range of >2000->5000 mg/Kg bw.

Acute inhalation toxicity:

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine has very low vapor pressure (8.07E-012 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.

Acute dermal toxicity:

Data available for the closely related read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9).The studies are as mentioned below:

1.In acute dermal toxicity study,10 male and female New Zealand white rabbits were treated with test chemical in the concentration of 2000 mg/kg bw according to OECD Guide-line 402 "Acute Dermal Toxicity"by dermal application for 14 days of observation period.No mortality was observed in treated rabbits at dose 2000 mg/kg bw.5 rabbits had abnormal defecation (soft stool, mucoid feces) on day 0 or 1. One of these animals also had wet, and subsequently, dry brown urogenital matting. These findings were considered to be a result of the bandage/restraint procedures used and not related to the test material. An additional spontaneaous occurrence of soft stool was noted on day 9 for one animal. There were no other findings. The test material induced generally very slight to slight erythema on all rabbits and very slight to slight edema on 8 rabbits. There was a single occurrence of moderate erythema at the day 1 observation. Desquamation was present on five sites by day 7. There were no other dermal findings. One site had very slight erythema at study termination (day 14). There were no remarkable changes or differences noted in body weights during the study. In necropsy findings, accessory splenic tissue, a common congenital abnormality in this strain of rabbit, was noted for four animals at the terminal necropsy. There were no other gross necropsy findings for all examined tissues.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rabbits were treated with test chemical by dermal application.

2.In acute dermal toxicity study,rabbits were treated with test chemical in the concentration of 5000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 5000 mg/kg bw.Therefore, LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.

Thus, based on the above summarised studies, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) and it’s closely related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) cannot be classified for acute dermal toxicity. Hence,based on the data available for the closely related across chemical,

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9)

is not likely to be toxic atleast in the dose range of >2000->5000 mg/Kg bw.

Based on the above experimental studies on N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) and it’s structurally similar and closely related read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(93964-07-9) cannot be classified for acute oral and dermal toxicity. For Acute inhalation toxicity wavier was added so, not possible to classify.