2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.

Endpoint summary

Description of key information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below:

1. Acute oral toxicity study was conducted using test chemical in groups of 5 Carworth-Wistar male rats at the concentration range of 1880-3230 mg/kg bw. The test chemical was dissolved in suitable vehicle and administered via oral route. The dosages are arranged in a logarithmic series differing by a factor of two. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality. 50% Mortality observed at 2410 mg/kg bw. Therefore, LD50 was considered to be 2410 mg/kg bw, wih 95% confidence limit of 1880-3230 mg/kg bw, when Carworth-Wistar male rats were treated with test chemical via oral route.

 2. Acute oral toxicity study was conducted using test chemical in rats at the concentration of 2000 mg/kg bw. No Mortality observed at 2000 mg/kg bw. Therefore, LD50 was considered to be >2000 mg/kg bw, when rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 2410 mg/Kg bw.

 

Acute Inhalation toxicity: 

2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) has very low vapour pressure (1.49E-10 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 structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below:

1. The acute dermal toxicity study was designed and conducted for test chemical 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

 2. Acute Dermal toxicity study was conducted using test chemical in groups of 4 albino New Zealand male rabbits at the concentration range of 2700-18500 mg/kg bw. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 is calculated as described by a technique closely akin to the one-day cuff method of Draize and associates. 50% Mortality observed at 7100 mg/kg bw. Therefore, LD50 was considered to be 7100 mg/kg bw, wih 95% confidence limit of 2700-18500 mg/kg bw, when groups of 4 albino New Zealand male rabbits were treated with test chemical by dermal application occlusively.

Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute dermal toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 7100 mg/Kg bw for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

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 2 acute oral toxicity studies as- WoE-2 and WoE-3.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material : 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.
- IUPAC name : N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine
- Molecular formula : C30H33N3
- Molecular weight : 435.60 g/mol
- Substance type : Organic
- Physical state : Liquid

Species:

rat

Strain:

other: 1. Carworth-Wistar rats 2. not specified

Sex:

male

Details on test animals or test system and environmental conditions:

1. TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90-120 grams
- Fasting period before study: Fasting was not done.
- Diet (e.g. ad libitum): Rockland rat diet
2. not specified

Route of administration:

other: 1. oral: gavage 2. oral: unspecified

Vehicle:

other: 1. Vehicle was used 2. unchanged (no vehicle)

Details on oral exposure:

1. not specified
2. not specified

Doses:

1. 2410 mg/kg (Range of 1880-3230 mg/kg bw)
2. 2000 mg/kg

No. of animals per sex per dose:

1. groups of 5
2. not specified

Control animals:

not specified

Details on study design:

1. not specified
2. not specified

Statistics:

1. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality.
2. not specified

Preliminary study:

1. not specified
2. not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

2 410 mg/kg bw

Based on:

test mat.

95% CL:

1 880 - 3 230

Remarks on result:

other: 50% Mortality observed

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No Mortality observed

Mortality:

1. 50% Mortality observed at 2410 mg/kg bw
2. No Mortality observed 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 chemcial 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) is not likely to be toxic atleast in the dose range of >2000 - 2410 mg/Kg bw.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below:

1. Acute oral toxicity study was conducted using test chemical in groups of 5 Carworth-Wistar male rats at the concentration range of 1880-3230 mg/kg bw. The test chemical was dissolved in suitable vehicle and administered via oral route. The dosages are arranged in a logarithmic series differing by a factor of two. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality. 50% Mortality observed at 2410 mg/kg bw. Therefore, LD50 was considered to be 2410 mg/kg bw, wih 95% confidence limit of 1880-3230 mg/kg bw, when Carworth-Wistar male rats were treated with test chemical via oral route.

 2. Acute oral toxicity study was conducted using test chemical in rats at the concentration of 2000 mg/kg bw. No Mortality observed at 2000 mg/kg bw. Therefore, LD50 was considered to be >2000 mg/kg bw, when rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 2410 mg/Kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 410 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from publication.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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 2 acute dermal toxicity studies as- WoE-2 and WoE-3.
Acute Dermal toxicity test was carried out to study the effects of the test chemicals on rodents.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material : 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.
- IUPAC name : N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine
- Molecular formula : C30H33N3
- Molecular weight : 435.60 g/mol
- Substance type : Organic
- Physical state : Liquid

Species:

other: 1. rat 2. rabbit

Strain:

other: 1. Sprague-Dawley 2. albino New Zealand rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

1. TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks were used.
- Weight at study initiation: The weight range of approximately 216.9 to 251.9 grams at initiation of dosing.
Body weights at the start : Male Mean: 241.18 g (= 100 %); Minimum : 235.8 g (- 2.23 %); Maximum : 251.9 g (+ 4.44 %)
Female Mean: 221.08 g (= 100 %); Minimum : 216.9 g (- 1.89 %); Maximum : 228.5 g (+ 3.36 %)
- Identification: Each rat was individually identified by the cage number.
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 to 21.8 degree centigrade.
- Humidity (%): 56.2% to 60.1%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: 11-07-2017 to 26-07-2017
2. TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg

Type of coverage:

other: 1. semiocclusive 2. occlusive

Vehicle:

other: 1. unchanged (no vehicle) 2. not specified

Details on dermal exposure:

1. TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
2. TEST SITE
- Area of exposure: The fur is removed from the entire trunk by clipping
- Type of wrap if used: impervious plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the film is removed
- Time after start of exposure:24-hour

Duration of exposure:

1. 24 hours
2. 24-hour

Doses:

1. 2000 mg/kg
2. 7100 mg/kg (Range of 2700-18500 mg/kg bw)

No. of animals per sex per dose:

1. 10 (5/sex)
2. groups of 4

Control animals:

other: 1. not specified 2. not specified

Details on study design:

1. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality, until sacrifice. Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time. The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction: Dermal reaction was observed daily for study period of 14 days.
Body weights: Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology: Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
2. not specified

Statistics:

1. No data
2. The LD50 is calculated as described by a technique closely akin to the one-day cuff method of Draize and associates.

Preliminary study:

1. No data
2. not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No morality was observed

Sex:

male

Dose descriptor:

LD50

Effect level:

7 100 mg/kg bw

Based on:

test mat.

95% CL:

2 700 - 18 500

Remarks on result:

other: 50% Mortality observed

Mortality:

1. Sex : Male Group I - All animals survived through the study period of 14 days.
Sex : Female Group I - All animals survived through the study period of 14 days.
2. 50% Mortality observed at 7100 mg/kg bw

Clinical signs:

1. Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.
2. not specified

Body weight:

1. Sex : Male Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 9.30% and 18.14% respectively.
Sex : Female Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 4.60% and 9.06% respectively.
2. not specified

Gross pathology:

1. Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
2. not specified

Other findings:

1. - Other observations: Evaluation of Dermal Reaction
Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
2. not specified

Interpretation of results:

other: Not classified

Conclusions:

The test chemcial 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) is not likely to be toxic in the dose range of >2000 - 7100 mg/Kg bw for acute dermal toxicity.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below:

1. The acute dermal toxicity study was designed and conducted for test chemical 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

 2. Acute Dermal toxicity study was conducted using test chemical in groups of 4 albino New Zealand male rabbits at the concentration range of 2700-18500 mg/kg bw. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 is calculated as described by a technique closely akin to the one-day cuff method of Draize and associates. 50% Mortality observed at 7100 mg/kg bw. Therefore, LD50 was considered to be 7100 mg/kg bw, wih 95% confidence limit of 2700-18500 mg/kg bw, when groups of 4 albino New Zealand male rabbits were treated with test chemical by dermal application occlusively.

Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute dermal toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 7100 mg/Kg bw for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

7 100 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from publication.

Additional information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below:

1. Acute oral toxicity study was conducted using test chemical in groups of 5 Carworth-Wistar male rats at the concentration range of 1880-3230 mg/kg bw. The test chemical was dissolved in suitable vehicle and administered via oral route. The dosages are arranged in a logarithmic series differing by a factor of two. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality. 50% Mortality observed at 2410 mg/kg bw. Therefore, LD50 was considered to be 2410 mg/kg bw, wih 95% confidence limit of 1880-3230 mg/kg bw, when Carworth-Wistar male rats were treated with test chemical via oral route.

 2. Acute oral toxicity study was conducted using test chemical in rats at the concentration of 2000 mg/kg bw. No Mortality observed at 2000 mg/kg bw. Therefore, LD50 was considered to be >2000 mg/kg bw, when rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 2410 mg/Kg bw.

 

Acute Inhalation toxicity: 

2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) has very low vapour pressure (1.49E-10 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 structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below:

1. The acute dermal toxicity study was designed and conducted for test chemical 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

 2. Acute Dermal toxicity study was conducted using test chemical in groups of 4 albino New Zealand male rabbits at the concentration range of 2700-18500 mg/kg bw. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 is calculated as described by a technique closely akin to the one-day cuff method of Draize and associates. 50% Mortality observed at 7100 mg/kg bw. Therefore, LD50 was considered to be 7100 mg/kg bw, wih 95% confidence limit of 2700-18500 mg/kg bw, when groups of 4 albino New Zealand male rabbits were treated with test chemical by dermal application occlusively.

Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute dermal toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 7100 mg/Kg bw for acute dermal toxicity.

Justification for classification or non-classification

Based on the above experimental studies on 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar related read across substances, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute oral and dermal toxicity. For Acute Inhalation toxicity wavier were added so, not possible to classify.