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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin Irritation:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline was estimated to be not irritating to skin.

Eye Irritation:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential of 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.

4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline was estimated to be not irritating to eyes.

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:
other: Weight of evidence based on structurally similar read across chemicals
Justification for type of information:
Weight of evidence based on structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
other: Weight of evidence based on structurally similar substances
Principles of method if other than guideline:
Weight of evidence based on structurally similar substances
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline
- IUPAC name: 4-[(2-chloro-4-nitrophenyl)diazenyl]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline
- Molecular formula: C22H29ClN4O4
- Molecular weight: 448.9481 g/mole
- Smiles : CCN(CCOC(C)OCC(C)C)c1ccc(cc1)/N=N/c2ccc(cc2Cl)[N+](=O)[O-]
- InChl: 1S/C22H29ClN4O4/c1-5-26(12-13-30-17(4)31-15-16(2)3)19-8-6-18(7-9-19)24-25-22-11-10-20(27(28)29)14-21(22)23/h6-11,14,16-17H,5,12-13,15H2,1-4H3/b25-24+
- Substance type: Organic
- Physical state: Solid crystalline powder (white)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
500 mg moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed
Interpretation of results:
other: not irritating
Conclusions:
On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline was estimated to be not irritating to skin.
Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.

A study was performed to determine the irritation potential of the structurally similar read across chemical following the procedures outlined in OECD 404.One day prior to the application of the test chemical, the dorsal area of the trunk of 3 female New Zealand White rabbits was clipped free of fur. 500 mg of the test chemical was moistened with water was applied clipped skin of 3 rabbits under semi-occlusive conditions for 4 hours. Subsequently, the dressings were removed, any residual test substance was wiped off. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches.

No signs of irritation were noted on the rabbit skin. Brown/yellow skin discolouration was observed at the 1-hour time-point but did not prevent the accurate assessment of erythema.

Based on the observations, the test chemical can be considered not irritating to rabbit skin.

The above results were supported by a study performed in accordance with OECD 404 and 92/69/EEC Annex V Guidelines to determine the irritation potential of the structurally similar read across chemical. 0.5 g of the test chemical was moistened with water and applied to 6.25 cm² area of intact skin of 3 female New Zealand albino rabbits under semi-occlusive conditions for 4 hours. Remaining test substance was removed by swabbing with cotton wool swabs soaked in warm water. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches. An index of Cutaneous Primary Irritation was calculated from the mean scores at the sites and at each time point.

No signs of irritation were noted on the rabbit skin. Red/orange staining was reported at all time points. The primary irritation index was reported to be 0.0.

Based on the scores and observations, the test chemical can be considered not irritating to rabbit skin.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

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:
other: Weight of evidence based on structurally similar substances
Justification for type of information:
Weight of evidence based on structurally similar substances
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
other: Weight of evidence based on structurally similar substances
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the ocular irritation potential of 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline
- IUPAC name: 4-[(2-chloro-4-nitrophenyl)diazenyl]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline
- Molecular formula: C22H29ClN4O4
- Molecular weight: 448.9481 g/mole
- Smiles : CCN(CCOC(C)OCC(C)C)c1ccc(cc1)/N=N/c2ccc(cc2Cl)[N+](=O)[O-]
- InChl: 1S/C22H29ClN4O4/c1-5-26(12-13-30-17(4)31-15-16(2)3)19-8-6-18(7-9-19)24-25-22-11-10-20(27(28)29)14-21(22)23/h6-11,14,16-17H,5,12-13,15H2,1-4H3/b25-24+
- Substance type: Organic
- Physical state: Solid crystalline powder (white)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
other: undiluted; aqueous saline suspension
Controls:
not specified
Amount / concentration applied:
100 mg of the powdered dye; 0.1 ml of 33% aqueous saline suspension
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed
Interpretation of results:
other: not irritating
Conclusions:
On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential of 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.
4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline was estimated to be not irritating to eyes.
Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of 4-((2-Chloro-4 -nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.

The ocular irritation potential of the structurally similar read across chemical was assessed in rabbits. 100 mg of the powdered dye was instilled in one eye of 6 rabbits and the other eye served as control. The treated eyes were observed and scored at 1, 2, 3, and 7 days. The maximum attainable score was 110.

No signs of irritation were observed in the treated eyes of rabbits at any time point.

The scores obtained at 1, 2, 3, and 7 days were 0.0. Hence, the test chemical can be considered to be not irritating to rabbit eyes.

This result is further supported by an eye irritation study performed in rabbits to determine the irritation potential of the structurally similar read across chemical.

0.1 ml of 33% aqueous suspension in saline was instilled in to rabbit eyes and observed for effects (duration, number of rabbits and observation period not mentioned). No signs of irritation were observed. Hence, the test chemical was considered to be not irritating to rabbit eyes.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to eyes and it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of 4-((2-Chloro-4 -nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.

A study was performed to determine the irritation potential of the structurally similar read across chemical following the procedures outlined in OECD 404.One day prior to the application of the test chemical, the dorsal area of the trunk of 3 female New Zealand White rabbits was clipped free of fur. 500 mg of the test chemical was moistened with water was applied clipped skin of 3 rabbits under semi-occlusive conditions for 4 hours. Subsequently, the dressings were removed, any residual test substance was wiped off. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches.

No signs of irritation were noted on the rabbit skin. Brown/yellow skin discolouration was observed at the 1-hour time-point but did not prevent the accurate assessment of erythema.

Based on the observations, the test chemical can be considered not irritating to rabbit skin.

The above results were supported by a study performed in accordance with OECD 404 and 92/69/EEC Annex V Guidelines to determine the irritation potential of the structurally similar read across chemical. 0.5 g of the test chemical was moistened with water and applied to 6.25 cm² area of intact skin of 3 female New Zealand albino rabbits under semi-occlusive conditions for 4 hours. Remaining test substance was removed by swabbing with cotton wool swabs soaked in warm water. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches. An index of Cutaneous Primary Irritation was calculated from the mean scores at the sites and at each time point.

No signs of irritation were noted on the rabbit skin. Red/orange staining was reported at all time points. The primary irritation index was reported to be 0.0.

Based on the scores and observations, the test chemical can be considered not irritating to rabbit skin.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Eye Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of 4-((2-Chloro-4 -nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline.

The ocular irritation potential of the structurally similar read across chemical was assessed in rabbits. 100 mg of the powdered dye was instilled in one eye of 6 rabbits and the other eye served as control. The treated eyes were observed and scored at 1, 2, 3, and 7 days. The maximum attainable score was 110.

No signs of irritation were observed in the treated eyes of rabbits at any time point.

The scores obtained at 1, 2, 3, and 7 days were 0.0. Hence, the test chemical can be considered to be not irritating to rabbit eyes.

This result is further supported by an eye irritation study performed in rabbits to determine the irritation potential of the structurally similar read across chemical.

0.1 ml of 33% aqueous suspension in saline was instilled in to rabbit eyes and observed for effects (duration, number of rabbits and observation period not mentioned). No signs of irritation were observed. Hence, the test chemical was considered to be not irritating to rabbit eyes.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be not irritating to eyes and it can be further classified under the category “Not Classified” as per CLP regulation.

 

Justification for classification or non-classification

The results of the experimental studies from the structurally similar read across substances indicate a possibility that 4-[(2-chloro-4-nitrophenyl)diazenyl]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline can be not irritating to skin and eyes.

Hence by applying the weight of evidence approach, 4-[(2-chloro-4-nitrophenyl)diazenyl]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline can be considered to be not irritating to skin and eyes. It can be classified under the category “Not Classified” as per CLP regulation.