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

Endpoint summary

Description of key information

Skin irritation

Data available for the structurally similar read across chemicals has been reviewed to determine the skin irritation potential 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:

 

The skin irritation study of read across substance was conducted on intact skin of three rabbits. Under the conditions of this experiment the test material was observe to cause no irritation when applied to intact rabbit skin. In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period. No corrosion effect had occurred on the skin. The calculated Mean irritation index for intact skin was observed to be 0. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be a skin irritant.

 

The above result was further supported by another experimental study conducted for read across chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. 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. The overall irritation score of the substance was obtained 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 the test substance was non-Irritating to the skin of rats under the experimental conditions tested.

 

Based on the above summarized studies for target chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8)and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

Data available for the structurally similar read across chemicals has been reviewed to determine the ocular irritation potential 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:

 

Under the conditions of this experiment the test material was observed to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae, which could be related to compound effects, was observed. The Primary Irritation Index was found to be: Unrinsed Eyes: 1.6. No corrosion effect was observed at each of the measuring intervals. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be an eye irritant.

 

The above results were further supported by an eye irritation study conducted by authoritative database for another read across substance. This Ocular irritation was carried out in 2 albino rabbits to assess the irritation potential of test chemical. About 100 mg of undiluted diphenylamine was placed in rabbit’s eye and observed for any ocular changes for 10 days. Only slight iritis and moderate conjunctivitis were observed, which cleared after ten days.  Hence the test material was considered to be not irritating to the eyes of Albino rabbits.

 

Based on the above summarized studies for target chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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 closely related 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 skin irritation studies as- WoE-2 and WoE-3.
Skin irritation study of test chemical was conducted on rats and rabbits to assess its skin irritating effects.

GLP compliance:

not specified

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.Rabbit 2. Rat

Strain:

other: 1.New Zealand White 2.Sprague-Dawley

Details on test animals or test system and environmental conditions:

1. Details on test animals
TEST ANIMALS
- Source: KLEENTIERFARM MADOERIN AG; 4414 FUELLINSDORF; SWITZERLAND
- Age at study initiation: 12 -16 weeks
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: The animals were caged individually in stainless steel cages.
- Diet (e.g. ad libitum): Standard kliba rabbit maintenance food;ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degC
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours/day
2. TEST ANIMALS
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 Female
Mean : 241.18 g (= 100 %)
Minimum : 235.8 g (- 2.23 %)
Maximum : 251.9 g (+ 4.44 %)
Total No. of animals : 5 Mean : 221.08 g (= 100 %)
Minimum : 216.9 g (- 1.89 %)
Maximum : 228.5 g (+ 3.36 %)
Total No. of animals : 5

- Identification: Each rat was individually identified by the cage number.
- Fasting period before study: No data available
- 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): 20.1 to 22.3 degree centigrade.
- Humidity (%): 55.7% to 59.6%
- 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

Type of coverage:

other: 1. occlusive 2. semiocclusive

Preparation of test site:

clipped

Vehicle:

other: 1. Polyethylene glycol / Saline (70/30 PARTS) 2. unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1. - Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration : 50%
2.2000 mg/kg bw

Duration of treatment / exposure:

1. 4 hours
2. 24 hours

Observation period:

1.72 hours
2. 14 days

Number of animals:

1. 3 (2 male and 1 female)
2. 10 (5/sex).

Details on study design:

1. TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): Observed at 1, 24, 48 and 72 hours.
SCORING SYSTEM:
- Method of calculation: Draize method.


2. 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.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.

SCORING SYSTEM: Draize Method.

OTHER OBSERVATIONS
Type and Frequency of Tests, Analyses and Measurements
Viability: Twice daily.
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.
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.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

14 d

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

14 d

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1. 1,4-bis(p-tolylamino)anthraquinone showed no irritation,when applied to intact rabbit skin.No destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect had occured on the skin.

2.Overall result:
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.

Other effects:

1. In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period.

2.Other effects:
Clinical Signs of Toxicity and Mortality
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. All animals survived through 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. All animals survived through the study period of 14 days.


Body Weight
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.

Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.

1. Not specified

2.Individual Animal - Evaluation of Dermal Reaction

 Laboratory Test Item Code :TAS/ 122/041

Test System : Sprague Dawley Rat

Sex : Male  

Group : I

Dose  : 2000 mg/kg body weight

Animal	Dermal	D A Y S
No.	Reaction	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
4	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

 Sex : Female  

Group : I

Dose  : 2000 mg/kg body weight

Animal	Dermal	D A Y S
No.	Reaction	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
6	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
7	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
8	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
9	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
10	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Table No. I

Summary of Clinical Signs of Toxicity and Mortality

Test System : Sprague Dawley Rat

Sex : Male

Group  No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No clinical signs observed	5	1 - 5	Day 0 - Day 14	0/5

 

 

Sex : Female

Group  No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No clinical signs observed	5	6 - 10	Day 0 - Day 14	0/5

 

  

Table No. II

Summary of Evaluation of Dermal Reaction

Test System : Sprague Dawley Rat

Sex : Male 

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No dermal reaction observed	5	1 - 5	Day 0 - Day 14	0/5

 

Sex : Female

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No dermal reaction observed	5	6 - 10	Day 0 - Day 14	0/5

 

 

 

Table No.III

Mean Body Weight and Percent Body Weight Gain (g)

Test System : Sprague Dawley Rat

Sex : Male

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	241.18	263.58	9.30	284.84	8.09	18.14
		± SD	6.54	6.02	1.15	3.97	1.25	1.58

 

Sex : Female

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	221.08	231.26	4.60	241.14	4.27	9.06
		± SD	4.43	5.79	0.78	6.90	0.57	1.14

 

  

 Table No.IV

Summary of Gross Pathological Findings

Test System : Sprague Dawley Rat

Sex : Male

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	1 - 5	TS	No abnormality detected

 

Sex : Female

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	6 - 10	TS	No abnormality detected

   

 TS = Terminal Sacrifice

 

                        

Interpretation of results:

other: Not irritating

Conclusions:

The test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8) was considered to be not irritating to the skin of rats and rabbits.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the skin irritation potential 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:

 

The skin irritation study of read across substance was conducted on intact skin of three rabbits. Under the conditions of this experiment the test material was observe to cause no irritation when applied to intact rabbit skin. In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period. No corrosion effect had occurred on the skin. The calculated Mean irritation index for intact skin was observed to be 0. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be a skin irritant.

 

The above result was further supported by another experimental study conducted for the read cross chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. 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. The overall irritation score of the substance was obtained 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 the test substance was non-Irritating to the skin of rats under the experimental conditions tested.

 

 

Based on the above summarized studies for target chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8)and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation study of test chemical was conducted on rabbits to assess its eye irritating effects.

GLP compliance:

not specified

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:

rabbit

Strain:

other: 1. New Zealand White 2. albino

Details on test animals or tissues and environmental conditions:

1.1. Details on test animals
TEST ANIMALS
- Source: KLEENTIERFARM MADOERIN AG; 4414 FUELLINSDORF; SWITZERLAND
- Age at study initiation: 12 -16 weeks
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: The animals were caged individually in stainless steel cages.
- Diet (e.g. ad libitum): Standard kliba rabbit maintenance food;ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degC
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours/day

2. Not specified

Vehicle:

unchanged (no vehicle)

Controls:

other:

Amount / concentration applied:

1. 100mg

2.Amount:100mg (0.1 g)
concentration applied:100 %

Duration of treatment / exposure:

single application

Observation period (in vivo):

1.72 hours
2.10 days

Number of animals or in vitro replicates:

1.3 (2 male and 1 female)
2.No data available

Details on study design:

1.REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were not washed.

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: No data

2.No data available

Irritation parameter:

other: Primary irritation index

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

10 d

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1. The test chemical showed no irritation when applied on the rabbit eye mucosa.
No discoloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to compound effects.
No corrosion effect was observed at each of the measuring intervals.

2.only slight iritis and moderate conjunctivitis, which cleared after ten days

Other effects:

1. No acute toxicological signs were observed in the animals during the test period.
2.only slight iritis and moderate conjunctivitis, which cleared after ten days

Interpretation of results:

other: not irritating

Conclusions:

The test material showed no irritation when applied on the rabbit eye mucosa.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the ocular irritation potential 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:

 

Under the conditions of this experiment the test material was observed to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae, which could be related to compound effects, was observed. The Primary Irritation Index was found to be: Unrinsed Eyes: 1.6. No corrosion effect was observed at each of the measuring intervals. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be an eye irritant.

 

The above results were further supported by an eye irritation study conducted by authoritative database for another read across substance. This Ocular irritation was carried out in 2 albino rabbits to assess the irritation potential of test chemical. About 100 mg of undiluted diphenylamine was placed in rabbit’s eye and observed for any ocular changes for 10 days. Only slight iritis and moderate conjunctivitis were observed, which cleared after ten days.  Hence the test material was considered to be not irritating to the eyes of Albino rabbits.

 

Based on the above summarized studies for target chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Data available for the structurally similar read across chemicals has been reviewed to determine the skin irritation potential 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:

 

The skin irritation study of read across substance was conducted on intact skin of three rabbits. Under the conditions of this experiment the test material was observe to cause no irritation when applied to intact rabbit skin. In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period. No corrosion effect had occurred on the skin. The calculated Mean irritation index for intact skin was observed to be 0. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be a skin irritant.

 

The above result was further supported by another experimental study conducted for read across chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. 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. The overall irritation score of the substance was obtained 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 the test substance was non-Irritating to the skin of rats under the experimental conditions tested.

 

Based on the above summarized studies for target chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8)and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

Data available for the structurally similar read across chemicals has been reviewed to determine the ocular irritation potential 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:

 

Under the conditions of this experiment the test material was observed to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae, which could be related to compound effects, was observed. The Primary Irritation Index was found to be: Unrinsed Eyes: 1.6. No corrosion effect was observed at each of the measuring intervals. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be an eye irritant.

 

The above results were further supported by an eye irritation study conducted by authoritative database for another read across substance. This Ocular irritation was carried out in 2 albino rabbits to assess the irritation potential of test chemical. About 100 mg of undiluted diphenylamine was placed in rabbit’s eye and observed for any ocular changes for 10 days. Only slight iritis and moderate conjunctivitis were observed, which cleared after ten days.  Hence the test material was considered to be not irritating to the eyes of Albino rabbits.

 

Based on the above summarized studies for target chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8)  and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical  is unlikely to cause skin and eye irritation. Hence 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar’ and ar’’-Me derivs (CAS no.: 92257-28-8)  can be classified under the category “Not Classified” for skin and eye as per CLP.